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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended primarily for other attorneys. Orange Book Blog is not edited by McDonnell Boehnen Hulbert & Berghoff LLP ("MBHB") or its clients. Therefore, no part of Orange Book Blog--whether information, commentary, or other--may be attributed to MBHB or its clients. Readers should be aware that MBHB represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MBHB clients. Orange Book Blog will always strive to be unbiased in its reporting. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-08

« FDA's Request for Comments on Ramipril 180-day Exclusivity Draws Letters from Eight Generic Companies | Main | Hatch-Waxman Tracker Update »

November 10, 2007

Pharma News Briefs

  • King Pharmaceuticals filed its 10-Q statement with the SEC on Friday, revealing that Cobalt Pharmaceuticals, the first ANDA filer for Altace (ramipril), recently notified King of its intent to launch its generic ramipril product, notwithstanding the settlement agreement between the two parties (see pages 12 and 20 of King's 10-Q filing).
  • Ranbaxy submitted new comments to FDA regarding granisetron 180-day exclusivity, largely supporting Teva's interpretation of the post-MMA "failure to market" forfeiture provisions.
  • Teva and Upsher-Smith recently submitted new comments to FDA regarding acarbose 180-day exclusivity (see FDA Law Blog).
  • Ranbaxy announced Thursday that it and Astellas/Boehringer Ingelheim settled their Hatch-Waxman case concerning generic Flomax (tamsulosin), and that it believes it is the first ANDA filer.
  • In other settlement news, GSK and Mylan recently announced settlement of their Hatch-Waxman case concerning generic Paxil CR (see this AP story).  Mylan is the first ANDA filer for a generic version of Paxil CR.
  • Momenta Pharmaceuticals announced Tuesday that FDA rejected its ANDA for a generic version of Lovenox (enoxaparin sodium injection), adding that "FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product" (see also Bloomberg.com).
  • Pharmalot posted a couple interesting stories this past week about a feud between Big Pharma and FDA over who's to blame for the recent decline in new drug approvals (see Nov. 5 post; Nov. 9 post).
  • There was more talk of replacing patents with prizes, this time at the World Health Organization meeting in Geneva (see WSJ Health Blog).
  • Eli Lilly & Co. created a buzz last week when it announced a deal with India's Glenmark Pharmaceuticals to acquire rights to a portfolio of TRPV1 antagonists (see also MarketWatch; Spicy IP).  Lilly also recently said it plans to ramp up its R&D spending in China (see Reuters).

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