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Your search for “patent exclusivity” returned the following results.
…is unable to go to market until patent expiration, then drug prices will remain high. If, however, a period of patent protection can be lopped off as a result of…
…a “reverse Photocure” scenario, the Patent and Trademark Office (“PTO”) has determined that U.S. Patent No. 6,132,766 (“the ‘766 patent”) covering Pacira Pharmaceuticals, Inc.’s (“Pacira’s”) EXPAREL (bupivacaine), approved on October…
…Term Extension (“PTE”) from the U.S. Patent and Trademark Office (“PTO”) for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62…
…vacating the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) and…
…LLC (“Inspirion”) – had previously been granted a period of 3-year exclusivity for it’s MORPHABOND (morphine sulfate) Extended-release Tablets drug product (approved under NDA 206544). Inspirion’s exclusivity is coded in…
…incentivize applicants to challenge patents by preserving (in many instances) the opportunity to obtain 180-day exclusivity. FDA recently reiterated this position in draft guidance on 180-day exclusivity (see our previous…
…reference listed drug (RLD) has forfeited its eligibility for 180-day generic drug exclusivity under section 505(j)(5)(B)(iv) of the act. Our presumption was that FDA stripped Ranbaxy of 180-day exclusivity eligibility…
…a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is…
…recognize a period of 5-year New Chemical Entity (“NCE”) exclusivity for certain Fixed-Dose Combination Drugs (“FDCs”) the Agency approved before announcing in February 2014 in a draft guidance document (and…
…FDA approved for VANCOCIN is not eligible for 3-year exclusivity because of the limitation on such exclusivity for a so-called “old antibiotic” like vancomycin set forth in FDC Act §…
…a bit of back story to the PREPOPIK NCE exclusivity dispute. In short, after denying NCE exclusivity for PREPOPIK, FDA seemed to indicate that the Agecny would grant the exclusivity…
…exclusivity, such as limiting ot to a specific abuse-deterrent formulation, or to a specific abuse-deterrent technology. Dissatisfied with FDA’s exclusivity determination, Egalet met with FDA officials in February 2017 and…
…any attached pediatric exclusivity). One type of exclusivity that is specifically not included in the new Purple Book is orphan drug exclusivity. Instead, FDA refers to the Agency’s searchable database…
…. . allows an ANDA applicant to omit from its labeling certain patent– and/or exclusivity-protected information concerning the pediatric use of a drug, and to include a disclaimer with respect…
…EXCLUSIVITY AND OTHER PROVISIONS.— This subsection does not affect— (A) the availability or scope of exclusivity under this section; (B) the availability or scope of exclusivity under section 505 for…