Examples of Purepac in a sentence
Teva and Purepac had agreed to share the 180-day generic exclusivity period.
In that case, independent generic manufacturer Teva had previously entered into an arrangement with Purepac Pharmaceutical Co., the first paragraph IV ANDA applicant with respect to the drug gabapentin.
The thirteen defendants were: (1) Barr Laboratories, Inc.; (2) Dey, L.P. and Dey, Inc.; (3) Ethex Corporation; (4) Ivax Corporation/Ivax Pharmaceuticals, Inc.; (5) Mylan Laboratories/Mylan Pharmaceuticals, Inc., and UDL Laboratories, Inc.; (6) Par Pharmaceuticals Companies, Inc./Par Pharmaceutical, Inc.; (7) Purepac Pharmaceutical Co.; (8) Boehringer Ingelheim Roxane Inc.
As noted, the FDA told Purepac that ac- cording to Warner-Lambert the patent covered gabapentin’s use for treating epilepsy.
Courts have observed that the word “continuing” as it appears in the statute reflects atypographical error and should probably be read as “containing.” See Purepac Pharm.
In sum, we agree with the district court that ‘‘the FDA’s determination that the ’479 patent claims the use of treating epilepsy ‘runs counter to the evidence before the agency,’ and is thus arbitrary and capricious.’’ Purepac, 238 F.
Persantine and Dipyridamole (manufactured by Purepac or Barr) must have an indication on the prescription that it is being used as an adjunct to Coumarin anticoagulants for the prevention of post-operative thromboembolic complications of cardiac valve replacement.
These requirements ensure that generic applicants are aware of all potential patent barriers to entry, and FDA fulfills its publication duty by compiling the patent data it receives from NDA holders in a resource that commonly is called “the Orange Book.” Purepac Pharm.
We start our analysis with the district court’s Purepac decision.
Under the district court’s analysis, what use the patent actually covered had no relevance, and properly so.Having considered TorPharm’s other challenges to Purepac and finding them without merit, we will affirm the judgment of the district court.