FIRST AID Have label with you when obtaining treatment advice. If swallowed • Call a poison control center, doctor, or 1 -800-222-1222 immediately for treatment advice. • Have person sip a glass of water if able to swallow. • Do not induce vomiting unless told to do so by the poison control center or doctor. If on skin or
10-31 generic line.pdf
Vol. 24, No. 21
Oct. 31, 2007
Good for Generics
New guidelines on determining obviousness issued by the U.S.
INSIDE THIS ISSUE Patent and Trademark Office (PTO) earlier this month might make itharder for brand companies to obtain and defend pharmaceutical Patents: GSK sues PTO
patents, one legal expert says.
over new rule .Page 3 In its precedential KSR International v. Teleflex Inc. decision Courts: Bayer wins Avelox
earlier this year, the Supreme Court decided that the standards put forth by the 1966 Graham v. John Deere Co. case are the basis fordetermining obviousness rather than rigid application of the teach- Litigation Briefs .Page 5
ing, suggestion or motivation test. The PTO guidelines emphasizethat patent examiners should use the same standards when reviewing Wyeth grants Sun covenant not to sue .Page 6 But according to Shannon Mrksich, attorney with Brinks Hofer Teva, Astellas settle over Gilson & Lione, the KSR and Graham obviousness standards, which (See Obviousness, Page 2)
GSK, Mylan enter agree-ment on Paxil CR.Page 7 Nears Approval in Europe
vokes AstraZeneca's Sym- Two more biosimilar epoetin products are close to entering the bicort patent .Page 7 market in Europe after the European Medicines Agency (EMEA) Spanish court rules for Pfiz- adopted positive opinions this month. er in Lipitor case .Page 7 Hospira's Retacrit (epoetin zeta) and Stada's Silapo (epoetin ze- FDA: Teva asks agency
ta) are biosimilar to Janssen-Cilag's Eprex (epoetin alfa) — market- about generic Kytril exclu- ed in the U.S. as Procrit — an erythropoiesis-stimulating agent (ESA) indicated for treating anemia associated with chronic kidneydisease and cancer chemotherapy. Experts give advice onsubmitting bioequivalence The EMEA's Committee for Medicinal Products for Human Use recommended approval of the products, and the European Com-mission (EC) will make the final decision. The companies expect to Drug Approvals .Page 10
receive approval before the end of the year. (See Biosimilar, Page 4)
Oct. 31, 2007
Obviousness, from Page 1
patent challengers to present pretty reasonableobviousness cases," Mrksich said.
are aimed at inventions that combine previouslyknown elements, can't be applied fairly to chemi- In addition to its obviousness guidelines, the cal patents.
PTO has issued a new final rule on patent claimsand continuations (Generic Line, Sept. 5). The In drug discovery, companies initially file a new rule is part of the PTO's efforts to reduce the patent for a whole family of compounds before application backlog, patent experts said at a re- narrowing in on the particular molecule and for- cent meeting with reporters.
mulation that is effective as a drug.
The brand industry is concerned that the rule Of particular concern to Mrksich, KSR and will make it harder to patent inventions. Indeed, the PTO guidelines reestablish "obvious to try" GlaxoSmithKline has sued the PTO seeking to as a basis obviousness, "which I think is going to prevent the rule from going into effect Nov. 1 be a boon for the generic industry," she told (see story, Page 3).
Under the new guidelines, PTO examiners may reject a claim based on the rationale that one The Patent Reform Act, S. 1145 and H.R.
of ordinary skill in the art chose the invention 1908, aims to narrow the inequitable conduct de- from among a "finite number of identified, pre- fense (Generic Line, Oct. 3). While this provision dictable potential solutions to the recognized has the support of brand companies, industry as a need or problem." In other words, the invention whole is mainly concerned with the provision on was obvious to try.
calculating damages, experts said.
As an example, the guidelines cite Pfizer "Damages is the thing that unifies all propo- Inc. v. Apotex Inc. in which the U.S. Court of Ap- nents and opponents of the bill," Hans Sauer, as- peals for the Federal Circuit invalidated Pfizer's sociate general counsel for the Biotechnology In- Norvasc (amlodipine besylate) patent (Generic dustry Organization (BIO), said. The damages Line, April 4).
provision would require judges in patent infringe-ment cases to calculate the economic value of a The court determined that one of ordinary patent, which would make infringement cheaper skill in the art "would have been able to narrow and undermine incentives for innovation, accord- the group of potential salt-formers to a group of 53 anions known to form pharmaceutically ac-ceptable salts." Negotiations on this provision are ongo- ing, and experts agreed that once it is settled, The guidelines also mention a case in which other key issues, such as post-grant review, can the Federal Circuit Court ruled that the patent for be addressed more easily. That leaves it up to Johnson & Johnson's incontinence drug Ditropan the Senate to act since the House has already XL (oxybutynin HCl) — a sustained-release for- passed its version of the bill (Generic Line, mulation of an older drug — was invalid. "The claims were obvious because it would have beenobvious to try the known methods for formulat- "It's very hard to predict whether patent re- ing sustained-release compositions," the guide- form will be successful in this Congress," Phil lines state.
Kiko from Foley & Lardner, former generalcounsel and chief of staff of the House Judiciary "These guidelines just make it so much easi- Committee, said. "It's important for Congress to er for examiners to reject cases and also for get this right." — Breda Lund Oct. 31, 2007
GSK Sues PTO
application, it must file an examination-support doc- Over New Final Rule
ument (ESD) and perform a preexamination search.
GlaxoSmithKline (GSK) filed a complaint However, GSK pointed out that neither the against the U.S. Patent and Trademark Office final rule nor its comments indicate whether the (PTO) seeking to permanently enjoin the agency applicant must undertake electronic searches, from implementing its final rule limiting the manual searches or both, or which libraries must number of continuing applications firms can file. be searched.
Under the final rule, any third or subsequent The company also argued that the final rule continuation or continuation-in-part application, as is an unconstitutional, arbitrary and capricious well as any second or subsequent request for contin- action amounting to the regulatory taking of ued examination, must contain justification of why GSK's property rights. the new evidence was not previously submitted.
"By imposing arbitrary restrictions on The Biotechnology Industry Organization GSK's ability to prosecute its patent applications, said the rule will make it more difficult for phar- the final rules diminish greatly the value of maceutical and biotech companies to patent their GSK's pending and future patent applications by inventions (Generic Line, Sept. 5). The rule goes depriving GSK the ability to claim fully and into effect Nov. 1.
completely its inventions, resulting in unconstitu-tional taking," the company said.
The House of Representatives recently passed the Patent Reform Act, H.R. 1908, which Information on the rule is available at www.
gives the PTO the authority to issue regulations relating to continuing applications, but the bill /clmcontfinalrule.html. — Christopher Hollis has not become law. GSK highlighted that fact in its complaint, EDITORIAL ADVISORY BOARD filed in the U.S. District Court for the Eastern Dis- trict of Virginia. "Congress has not yet granted the PTO the authority to make rules of practice that re- Quinn Emanuel Urquhart Oliver & Hedges strict continuing applications — if Congress had al- New York, N.Y.
ready given the PTO such authority … H.R. 1908 would be redundant and meaningless," GSK said.
Vice President, Government AffairsBarr Pharmaceuticals Another aspect of the rule that GSK object- Washington, D.C.
ed to concerns justifying continuing applications.
The justification presents firms with a dilemma in light of PTO rules of professional conduct that Synthon Pharmaceuticals bar knowingly false and misleading statements, Chapel Hill, N.C.
Kathleen JaegerPresident, Chief Executive Officer GSK also argued that the new limit on the Generic Pharmaceutical Association number of claims is inappropriate because com- Arlington, Va.
panies are specifically permitted to file "one or more claims" under current law. Managing Director, Healthcare Investment BankingFriedman, Billings, Ramsey Under the final rule, when an applicant files Arlington, Va.
more than 25 claims or five independent claims per Oct. 31, 2007
Biosimilar, from Page 1
Court Rules for
Last month, the EC approved the first Bayer in Avelox Case
biosimilar ESA: Sandoz's Eprex biosimilar A district court ruled in favor of Bayer in (Generic Line, Sept. 5). Sandoz also was the first patent litigation involving the antibiotic Avelox, company to receive European and U.S. clearance thwarting Dr. Reddy's Laboratories' attempt to for a biosimilar product with its human growth market a generic version of the drug before Bay- hormone Omnitrope (somatropin). er's patents expire.
The EMEA recently said it received eight Bayer filed suit in 2004 in the U.S. Dis- biosimilar applications in the first half of 2007 and trict Court for the District of Delaware after expects to receive eight more by the end of the year.
Dr. Reddy's submitted an abbreviated new Hospira and Stada have a co-development drug application (ANDA) for Avelox (moxi- agreement for biosimilar epoetin with Stada being floxacin HCl) challenging two patents on the responsible for developing the product and obtain- ing approval. Hospira holds rights to market epoet- The '517 patent covers the quinolone family in zeta in most of Europe while the companies will of compounds and expires in 2011, while the share marketing in Germany. The companies plan '942 patent covers specific stereoisomers and ex- to launch their products early next year.
pires in 2014.
Hospira said it is investing significantly in Dr. Reddy's argued that the '517 patent developing biosimilars even though there is no would have been obvious. But the court found biosimilar approval pathway in the U.S. that the company failed to demonstrate "that a While one bill aiming to establish a way for person of ordinary skill in the art would have had the FDA to approve biosimilars — the Biologics reason to attempt to make the claimed composi- Price Competition and Innovation Act, S. 1695 tions, or that such a person would have had a rea- — was voted out of the Senate Health, Educa- sonable expectation of success in doing so," ac- tion, Labor and Pensions Committee several cording to the Oct. 25 opinion.
months ago, it did not pass as part of the FDA The court also disagreed with Dr. Reddy's Amendments Act (Generic Line, Sept. 19).
argument that the '942 patent is invalid due to The bill's supporters, including Rep. Henry double patenting because a claim of the '942 Waxman (D-Calif.), are confident legislation patent is based on claims of the '517 patent. The could pass by the end of this Congress (Generic company failed to provide clear and convincing Line, Oct. 3).
evidence "to demonstrate that the compounds areobvious variants of each other," the court ruled.
"Creating an approval pathway for safe and ef- fective biogenerics is not only a fiscally responsible For both patents, Dr. Reddy's alleged that choice but also a socially responsible one," Hospira the patent applicants committed inequitable con- Chairman and CEO Christopher Begley said last duct by failing to disclose several prior art refer- month at GPhA's Annual Policy Conference. "When ences to patent examiners. The court, however, lifesaving drugs are not affordable — regardless of ruled that Dr. Reddy's failed to show an adequate their safety and efficacy — they are irrelevant." level of intent to deceive.
Upon the creation of an approval pathway, The court concluded that Dr. Reddy's AN- the first biosimilar products to hit the market in DA cannot be approved until the patents expire.
the U.S. will be biosimilar epoetin products, a re- A Dr. Reddy's spokeswoman said the company is cent Decision Resources report predicted (Gener- considering its options, including the possibility ic Line, Oct. 3). — Breda Lund of an appeal. — Breda Lund
Oct. 31, 2007
PATENT LITIGATION BRIEFS Alcon v. Barr
The company has asked the court to rule that Barr Laboratories recently submitted an ab- the FDA may not approve Barr's product until breviated new drug application (ANDA) for the patents expire.
generic Patanol with Paragraph IV certifications,prompting Alcon Laboratories to file suit last Sciele v. Mylan
week in the U.S. District Court for the Northern Sciele Pharma initiated patent litigation District of Illinois.
against Mylan after receiving notice that the com-pany submitted an abbreviated new drug applica- Patanol (olopatadine HCl) is indicated for tion seeking to market a generic version of the treating the signs and symptoms of allergic con- hypertension drug Sular.
Mylan's application contained a Paragraph The product had U.S. sales of approximate- IV certification for the '741 patent of which Sci- ly $320 million during the 12-month period that ele is the official licensee. The patent covers ended in August, according to Barr.
press-coated dihydropyridines tablets.
Unlike a previous ANDA filed by Apotex In its notice to Sciele, Mylan said its product that challenged only the '805 patent, which ex- would not infringe on this patent, but Sciele said in pires in 2015, Barr's application also chal- its Oct. 22 complaint that the letter does not pro- lenges the '863 patent, which expires in 2010.
vide enough information and asks the court to en- Alcon sued Apotex in the same court in No- join Mylan from marketing generic Sular (nisol- vember 2006.
dipine) until the patent expires in June 2008.
Oct. 31, 2007
Wyeth Won't Sue Sun for
Impax in April 2006 in the U.S. District Court Generic Effexor XR Filing
for the District of Delaware (Generic Line,April 19, 2006).
Wyeth has decided not to sue Sun Pharma- Final approval of Impax's product is de- ceutical Industries over its abbreviated new drug pendent on either the resolution of the lawsuit or application seeking to market generic Effexor the expiration of the 30-month stay, as well as the XR, despite the fact that Sun's application con- expiration of any generic exclusivity, Impax said.
tains Paragraph IV certifications for multiplepatents that expire in 2017.
"We intend to continue to vigorously defend the ongoing patent litigation with Wyeth and look Wyeth markets the antidepressant as Effexor forward to prevailing and bringing this important (venlafaxine HCl) immediate-release tablets and generic product to market," Larry Hsu, president Effexor XR extended-release capsules. Teva and CEO of Impax, said Oct. 18.
Pharmaceutical markets a generic version of Ef-fexor immediate-release tablets, which it Effexor is the highest-selling antidepressant in launched last year after settling with Wyeth in the world and Wyeth's top product. U.S. sales of patent litigation related to Effexor XR (Generic Effexor XR were approximately $2.7 billion during Line, Nov. 2, 2005).
the 12-month period that ended in August, accord-ing to Wolters-Kluwer Health. — Breda Lund Sun's generic product, in the form of ex- tended-release tablets, would be equivalent to Ef-fexor XR 37.5-, 75- and 150-mg capsules, thecompany said Oct. 16.
Teva to Launch Generic
Sun is the only company to submit an appli- Adenoscan Three Years Early
cation seeking approval for a generic venlafaxineHCl extended-release tablet, according to Wyeth.
Teva Pharmaceutical Industries will be able The covenant between Sun and Wyeth prevents to market generic Adenoscan under license in Sep- Sun from seeking a declaratory judgment of in- tember 2012 as part of a settlement agreement fringement, so the company cannot initiate patent with Astellas Pharma and King Pharmaceuticals.
litigation, Andrew Berdon, a partner with Quinn The agreement settles litigation filed in the Emanuel Urquhart, explained.
U.S. District Court for the District of Delaware.
A Wyeth spokeswoman told Generic Line Astellas and King sued Teva in 2005 after the that Sun's product won't be AB-rated and likely company filed an abbreviated new drug applica- won't win final approval until the 180-day peri- tion seeking approval to market generic od of marketing exclusivity Teva is entitled to as Adenoscan (adenosine) before the expiration of the first filer expires. Under its settlement with King's '877 patent in May 2009 (Generic Line, Wyeth, Teva will be able to launch generic Ef- fexor XR capsules in July 2010, unless the out- Subject to the district court's approval, the come of one of the other patent cases results in cases will be dismissed and the patents will re- an earlier launch.
main in place. The '296 patent expires in March Wyeth is involved in litigation with sever- 2015. The other terms of the settlement are confi- al firms seeking to market generic Effexor XR capsules, the company said in an August SEC Adenoscan, marketed by Astellas in the filing. Wyeth recently filed suit against Sandoz U.S., is a pharmacologic stress agent indicated as an adjunct to thallium-201 myocardial perfusion One of the companies, Impax Laborato- scintigraphy in diagnosing coronary artery dis- ries, has received tentative FDA approval for ease in patients unable to exercise adequately.
its generic Effexor XR capsules. Wyeth sued Oct. 31, 2007
Mylan to Market Generic
patent that covers the Symbicort (formoterol fu- Paxil CR Next Year
marate dihydrate/budesonide) combination and useas an asthma treatment in 17 European countries, GlaxoSmithKline (GSK) and Mylan have AstraZeneca said. The patent would have expired entered into a settlement agreement under which in 2015 in most of these countries.
Mylan will be able to market generic Paxil CR Two other patents covering the use of Sym- beginning Oct. 1, 2008. bicort for chronic obstructive pulmonary disease Mylan will market 12.5-, 25- and 37.5-mg are currently under appeal and opposition.
generic Paxil CR (paroxetine HCl) extended-re- In addition to these patents, Symbicort has lease tablets, which had U.S. sales of approxi- data exclusivity through at least August 2010 in mately $342 million during the 12-month period most major European markets. Worldwide sales that ended in June.
of Symbicort reached $1.18 billion in 2006 with Mylan was the first to file an abbreviated new Europe accounting for $1.02 billion, according to drug application (ANDA) for Paxil CR 12.5 and 25 mg containing several Paragraph IV certifications The EPO recently upheld four patents cover- and is eligible for 180 days of marketing exclusivi- ing AstraZeneca's heartburn drug Nexium (es- ty for these strengths. GSK didn't sue Mylan ini- omeprazole magnesium) (Generic Line, Oct. 17).
tially after it submitted its ANDA, and the FDA granted final approval to Mylan's ANDA in June.
But the U.S. Patent and Trademark Office granted GSK a new patent for Paxil CR, the '640 Pfizer Prevails in Spanish
patent, which was added to the Orange Book.
Mylan amended its ANDA to include a Paragraph Lipitor Patent Challenge
IV certification for the '640 patent, prompting A Spanish appeals court has handed Pfizer GSK to file suit June 25 in the U.S. District another victory in its effort to protect its block- Court for the District of New Jersey. buster cholesterol-lowering drug Lipitor, uphold- The '640 patent expires in 2016 and covers ing the patent covering the active ingredient and a controlled-release composition of paroxetine reversing a lower court decision. "that reduces the incidence of nausea and vomit- Lek Pharmaceuticals was one of four com- ing," according to court records. Under the settle- panies to challenge the Spanish Lipitor (atorvas- ment, the case will be dismissed with prejudice.
tatin calcium) patent, which expires in July 2010.
Earlier this month Mylan settled litigation with Lek can appeal the decision in the Supreme UCB involving Keppra (levetiracetam) and will be able to market a generic version of that drug in No- The drug is sold in Spain under the brand vember 2008. — Breda Lund names Zarator and Cardyl. Earlier this year, a lower Spanish court ruled in favor of Pfizer in a Lipitor patent challenge initiated by Ranbaxy Laboratories. Pfizer alsoprevailed in patent litigation with Ranbaxy in Ire- The European Patent Office (EPO) has re- land (Generic Line, Aug. 8).
voked AstraZeneca's combination patent for Ranbaxy successfully invalidated the active Symbicort following an appeal by a group of ingredient patent in Canada earlier this year, but the Canadian Federal Court has since upheld Pfiz- Liconsa, Miat, Generics UK and Norton er's patent covering a crystalline form of atorvas- Healthcare were successful in challenging the tatin (Generic Line, Sept. 19). — Breda Lund Oct. 31, 2007
Teva Requests Assurance of
Under the MMA, the first applicant forfeits Generic Kytril Exclusivity
its 180-day exclusivity if it doesn't launch itsproduct by the later date from among two sets of Teva Parenteral Medicines recently made its possible deadlines. One set has to do with when case to the FDA that it is entitled to 180-day ex- the ANDA was submitted and approved, and the clusivity for its generic version of Kytril.
other set relates to judicial actions. This is the latest in a string of correspon- Teva called these two sets of forfeiture pro- dence with the FDA on exclusivity issues. Lupin visions "baskets." The company noted that is has and another company sent letters to the agency triggered a deadline in the first basket by failing last month disputing Cobalt Pharmaceuticals' to launch within 30 months of submitting the claim to generic Altace (ramipril) exclusivity ANDA. Since none of the judicial provisions in (Generic Line, Oct. 17). Previously, the FDA's the second basket has been triggered, the compa- Office of Generic Drugs wrote to firms that sub- ny's exclusivity remains intact.
mitted abbreviated new drug applications (AN-DAs) for generic Precose (acarbose) for input on "Until both baskets have been ‘closed,' it is exclusivity (Generic Line, Oct. 3).
impossible to determine which potential forfei-ture trigger … occurs ‘later' and thus results in a In its Sept. 28 letter, posted on the FDA's forfeiture of the first applicant's entitlement to website Oct. 17, Teva argued that it has not for- exclusivity," Teva wrote.
feited the exclusivity period it deserves as thefirst to submit an ANDA containing a Paragraph IV certification for Roche's anti-emetic Kytril(granisetron HCl).
The company added that Roche could still decide to sue, and Teva could realistically choose Teva submitted its ANDA in May 2004 with to initiate a declaratory judgment. "Short of gaz- a Paragraph III certification for Roche's '808 ing into a crystal ball, there is simply no conceiv- patent, which expires this December, and a Para- able mechanism for determining whether these graph IV certification for the '548 patent, which contingencies will come to pass and thus whether expires in 2019. The FDA tentatively approved any such occurrence is (or would be) ‘later' than Teva's application in August 2005.
the passage of 30 months since Teva submitted itspath-breaking Paragraph IV ANDA for generic Although Roche has never sued the compa- Teva also noted that Congress' intent in the ny for patent infringement, Teva "remains subject MMA was to prevent first filers from "parking" to the possibility of a patent infringement suit by their exclusivity and delaying generic entry. But Roche, and it retains the statutory right to file a the issue here is that Teva submitted its applica- declaratory judgment actions seeking patent cer- tion too early, so the 30-month period expired be- tainty," the company wrote.
fore any of the provisions in the second basketcame to pass.
Teva said it expects to receive final approval for its product when the '808 patent expires Dec.
The company assured the FDA that it fully 29, and it will begin marketing generic Kytril intends to launch its product on receiving final then. But the company is unsure about the status approval in December.
of its exclusivity, due to the forfeiture provisionsin the Medicare Modernization Act (MMA), and The letter is available at www.fda.gov/ohr has asked the agency to confirm its eligibility for 180-day exclusivity for generic Kytril.
Oct. 31, 2007
takes roughly six months less time than standard Submissions Speed Review
review, Conner noted.
With the FDA struggling to overcome the con- Conner said sponsors should consult the siderable generic application backlog, agency offi- agency's online dissolution database and the on- cials recently shared tips on how to make sure bioe- line individual product bioequivalence recom- quivalence submissions enjoy a speedy review.
mendations, which the agency unveiled earlierthis year (Generic Line, June 13).
The Office of Generic Drugs said it has re- ceived and approved more generic drug applica- Clinical Endpoint Studies
tions this year than any other year (Generic Line,Oct. 17). Dale Conner, director of the Division of Locally acting drugs, such as topical prod- Bioequivalence, told attendees at GPhA's Fall ucts, require clinical endpoint studies to demon- Technical Conference earlier this month that there are actions sponsors can take to ensure theirapplications don't get sent to the back of the line, One way to help the agency efficiently review such as making sure bioequivalence submissions study protocol is to ensure the study design is similar are well organized and complete.
to the late-phase studies of the reference drug butwith key differences, Associate Director for Medical Roughly 25 percent of applicants fail to in- Affairs Dena Hixon said at the conference.
clude necessary frozen storage stability studies inbioequivalence submissions, leading to a defi- For one, test the indication that provides the ciency letter and delayed review, Conner said.
greatest sensitivity but that is also practical. Forexample, pediatric trials can raise ethical issues, Generic drug applicants frequently don't in- and there are very few drugs that are approved clude potency data in the bioequivalence section only for use in children, so most studies of pedi- of the application. Applications are divided up so atric drugs can be conducted in older children or more than one division or office can review them adults, Hixon said.
simultaneously, so it's important that the data isincluded in each relevant section, he said.
Studies should be placebo-controlled, but if that isn't possible, sponsors should provide an ex- In addition, applications sometimes include planation. To conduct a trial without a placebo repeated pharmacokinetic studies without criteria arm, it is necessary to show that past studies of within the standard operating procedures (SOPs) the product have shown low placebo response about which samples should be reanalyzed. "We and spontaneous resolution rates, she said.
could believe that you're picking and choosingdata to try to clean things up," Conner said.
Clinical endpoint studies can have a shorter "Your SOPs should clearly delineate the criteria." duration of treatment than the studies conductedon the reference drug. "The shorter study duration Some sponsors submit improper or incom- is more likely to give us a sense of the study, plete electronic tables. Submitting proper bioe- whereas the longer study duration will likely wash quivalence data summary tables that are compli- out differences between products," Hixon said.
ant with electronic common technical documentstandards "can cut anywhere from days to a week Finally, "the lowest-labeled starting dose is or two off review time," he said. usually the dose that we would recommend,"Hixon said. "We don't want to use the higher Proper tables also can make a low-risk ap- doses, because the higher doses are more likely to plication eligible for administrative or abbreviat- be on the upper end of the dose-response curve." ed review. This type of review process generally Oct. 31, 2007
GENERIC DRUG APPROVALS Apotex Relaunches Generic Prilosec
Sun Wins Generic Exelon OK
After having its final approval for generic The FDA has granted final approval to Sun Prilosec withdrawn in June, Apotex is once again Pharmaceutical Industries' abbreviated new drug able to market its product.
application (ANDA) for a generic version of Ex-elon capsules.
The FDA converted the company's final ap- proval, which it received in October 2003, to a As one of the first companies to file an AN- tentative approval after AstraZeneca prevailed in DA for Exelon (rivastigmine tartrate) capsules patent litigation (Generic Line, June 13).
with a Paragraph IV certification, Sun will besharing 180-day marketing exclusivity. The com- Apotex then sued the FDA in the U.S. Dis- pany is involved in litigation with Novartis and trict Court for the District of Columbia, but the said it is evaluating its launch options.
court denied the company's motions for injunc-tive relief and stay pending appeal (Generic Line, Exelon capsules, indicated for treating de- Oct. 3). AstraZeneca's pediatric-exclusivity peri- mentia, have sales of approximately $200 million od for Prilosec (omeprazole) has now expired.
in the U.S., Sun said.
FDA OKs Ranbaxy's Generic Diovan
Companies Launch Generic Estrostep Fe
Ranbaxy Laboratories has received tentative Barr Laboratories received approval to mar- approval for its generic version of Novartis' hy- ket a generic version of Warner Chilcott's oral pertension drug Diovan with 180 days of market- contraceptive Estrostep Fe.
ing exclusivity upon launch.
The launch is the result of a 2004 agreement Recently, Novartis dismissed its lawsuit that Warner Chilcott and Barr entered to settle against Ranbaxy after the company converted its patent litigation, Barr said last week. Warner Paragraph IV certification for Diovan (valsartan) Chilcott granted Barr a nonexclusive license to to a Paragraph III (Generic Line, Oct. 3). Ran- launch a generic version of Estrostep Fe (norethin- baxy said it did not plan to market its product un- drone acetate/ethinyl estradiol tablets) six months til after the patents and pediatric exclusivity for before the expiration of the last patent.
the drug expire in 2017.
In addition, Warner Chilcott and Watson Diovan had sales of $1.3 billion during the Pharmaceuticals have launched an authorized 12-month period that ended in June, Ranbaxy said.
generic version of the drug.
Editor: Breda Lund
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