Paragraph IV Patent Certifications

On December 16, 2016 FDA has announced that it received Abbreviated New Drug Application’s (ANDA; U.S.C. § 355(j)(2)(A)(vii)(IV)) containing a “Paragraph IV” patent certification for the following drugs.

Drug Name  Dosage Form  Strength  RLD  Date of Submission
Aspirin and Omeprazole Delayed-release Tablets 81 mg/40 mg and 325 mg/40 mg Yosprala 10/13/2016
Buprenorphine Hydrochloride Buccal Film 75 mcg and 150 mcg Belbuca 10/24/2016
Difluprednate Ophthalmic Emulsion 0.05% Durezol 5/1/2014
Treprostinil Extended-release Tablets 0.25 mg and 1 mg Orenitram 5/19/2016

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