Menu
Your search for “patent exclusivity” returned the following results.
…Patent No. 6,716,867 (“the ‘867 patent”) listed in the Orange Book for PRECEDEX. The ‘867 patent is currently listed in the Orange Book for PRECEDEX with a “U-1472” patent use…
…Book patent listing, certification, and 180-day exclusivity for each ANDA applicant that not later than 120 dates after enactment of the QI Act (i.e., February 5, 2009) amends a pending…
…Tax Extenders Act (H.R. 4213) that could significantly curtail patent settlement agreements. As we previously reported, H.R. 4213 is also being eyed as a vehicle for legislatively granting a patent…
…lists one unexpired patent for the 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials strength at issue: U.S. Patent No. 6,716,867 (“the ‘867 patent”), which expires on March…
…(enoxaparin) and U.S. Patent No. 7,575,866 (“the ‘866 patent”) assigned to Momenta that generally relates “to methods for analyzing heterogeneous populations of sulfated polysaccharides” such as enoxaparin. Momenta sued generic…
…patent listed for ULTRAM, the pediatric exlusivity for which expires on April 12, 2020; and (2) U.S. Patent No. 6,254,887 (“the ‘887 patent”), a drug substance patent listed for ULTRAM…
…claimed that Sandoz’s approval for the unprotected methotrexate use and with labeling omitting the orphan drug exclusivity-protected colorectal cancer use violated the company’s orphan drug exclusivity. Spectrum’s Motion for Temporary…
…first generic drug challenges a patented drug, they get this treatment. This would extend that treatment for new generic drugs competing with off-patent brand drugs where there is no competition….
…would reinterpret the NCE exclusivity provisions of the FDC Act to award NCE exclusivity for a newly approved Fixed-Dose Combination Drug (“FDC”) containing an NCE and a previously approved drug. …
…exclusivity with respect to such drug under [FDC Act § 505(j)(2)(B)(iv)]; or (ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under [FDC Act §…
…and of itself, it is especially concerning for those companies that are “first applicants” who qualify for 180-day exclusivity for a particular drug product. One of the six 180-day exclusivity…
…to take stock of the cases in which FDA has made a determination about 180-day exclusivity forfeiture. The MMA added six 180-day exclusivity forfeiture provisions at FDC Act § 505(j)(5)(D)(i). Based…
…be a new chemical entity eligible for 5-year exclusivity. There are, however, several provisos . . . . The election of 5-year exclusivity can only be made if: (A)(i) the…
…IV certifications to four Orange Book-listed patents for the Reference Listed Drug, TOPROL-XL. In July 2006, subsequent to a lawsuit involving two of the patents and a decision by the…
…orphan drug exclusivity period. FDA approved Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adult patients in November 2018 with orphan drug exclusivity and subsequently approved a second…