Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
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Category: Pediatric Exclusivity
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Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston. The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity. You can download a copy of my slides here. In June, I gave a talk about…
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FDA Law Blog has a great post about a very interesting district court decision concerning Apotex’s attempt to market generic Prilosec before AstraZeneca’s pediatric exclusivity expires. Congress passed FDA reform legislation this week, albeit without provisions for biosimilars. (AP article; FDA Law Blog; PhRMA release). In the Pipeline is a great blog by a medicinal…
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SCOTUSblog reported on Wednesday that the Supreme Court has denied Pfizer’s emergency application for relief from the Federal Circuit’s ruling in the Norvasc case. TheStreet.com also has an article on the Supreme Court’s decision. On Tuesday, the Federal Circuit granted Mylan’s motion for summary reversal of the district court decision that had found Pfizer’s Norvasc…
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In a May 14 Order, the district court in D.C. denied all motions for reconsideration of its April 30 decision on Norvasc pediatric and 180-day exclusivity. FDA Law Blog has all the reconsideration briefs. Apotex and Mylan have now appealed to the D.C. Circuit. The In Vivo Blog reports that "Democratic and Republican staffers involved…
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Mylan Labs. et al. v. Leavitt et al., No. 07-579 (D.D.C. 2007) In an April 18 decision, the FDA determined that Pfizer is entitled to six months of pediatric exclusivity on Norvasc (amlodipine besylate), that Mylan may continue to sell its generic version of Norvasc, that FDA will approve Apotex’s generic Norvasc ANDA if and…
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Apparently not too many companies other than Pfizer are happy with the FDA’s decision last week regarding Norvasc (amlodipine besylate) exclusivity. On Monday, Mylan, Apotex, and Teva all filed motions with the U.S. District Court for the District of Columbia for injunctive relief from FDA’s decision. Today, everyone filed briefs in opposition to each others’…
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Ever since March 22, when the Federal Circuit invalidated claims 1-3 of Pfizer’s last remaining unexpired patent on Norvasc–U.S. Patent No. 4,879,303–Pfizer, Mylan and other ANDA filers have been scrambling. On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic. On March 26,…
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Norvasc update: FDA Law Blog reports that the district court has extended FDA’s deadline and that Zydus has filed a new citizen petition. Pharmalot reports on Barr Labs’ efforts to protect its Seasonale oral contraceptive from generic competition. The WSJ Health Blog summarizes today’s front-page WSJ article on Amgen’s recent troubles. The Business Standard and…
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A dozen companies have submitted letters in response to FDA’s March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues. Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for…
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Adams Respiratory and Mutual Pharma settle guaifenesin patent litigation: press release FTC subpoenas Cephalon over Provigil patent litigation settlements: AP; Phil. Bus. J. Glenmark first to file Zetia ANDA with paragraph IV certification: Bloomberg Senate holds hearing on pediatric exclusivity: Reuters Takeda awarded $16.8 million in fees in pioglitazone patent case: NY Law J.; Reuters
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