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
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: 180-Day Exclusivity
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As reported by FDA Law Blog, FDA determined on May 7 that Cobalt forfeited its 180-day exclusivity on acarbose and Cobalt sued FDA on May 8 for injunctive relief. Last Friday, for some reason, Cobalt voluntarily dismissed its suit against FDA. Also last Friday, FDA appealed the D.C. district court’s decision requiring relisting of Janssen’s…
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In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb sued Apotex for infringing the Orange Book-listed patent, U.S. Patent No. 4,847,265, thereby initiating an automatic 30-month stay of FDA approval of Apotex’s…
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Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete. The decision was affirmed without an opinion, under Rule 36. Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a…
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Earlier this week, FDA Law Blog provided an update on Teva’s suit against the FDA, seeking relisting of Janssen’s patent on Risperdal (risperidone) and confirmation of Teva’s 180-day exclusivity on a generic version of the drug. Last week, FDA Law Blog reported on a recent FDA determination that Watson Labs forfeited its 180-day exclusivity on…
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The New York Times had another article Thursday on the investigation into the Chinese supply of heparin. Pharmalot had this related post Friday. FTC Commissioner Jon Leibowitz wrote an editorial for the Washington Post Monday on "reverse-payment" settlements (or "pay-for-delay" settlements), and the FTC’s recently filed case against Cephalon, in particular. Dow Jones reported Monday…
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As we reported last November, the Federal Circuit’s decision invalidating U.S. Patent No. 5,061,722 on Altace (ramipril) was followed by a flood of letters to FDA concerning 180-day exclusivity for ramipril. FDA responded last week, shedding some light on how pre-MMA 180-day exclusivity issues are decided. In FDA’s response, posted January 29, FDA explained that…
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Earlier this week, FDA released its highly anticipated response concerning granisetron 180-day exclusivity. This marks the first time that FDA has interpreted the "failure to market" forfeiture provisions of the 2003 MMA. FDA Law Blog posted a nice summary of FDA’s response. FDA Law Blog also posted on a very interesting case recently filed by…
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A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva’s right to 180-day exclusivity for risperidone tablets; and (3) refrain from approving any other ANDAs for…
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Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials). Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva’s citizen petition–namely, whether Teva’s failure to market its generic product within 30 months of ANDA submission caused forfeiture…
Orange Book Blog 