Paragraph IV Patent Certifications

November 22, 2016

The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/2004). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Division of Filing Review at 240-402-8859, before making any decisions based on this information.


 Drug Name Dosage Form Strength RLD Date of Submission
BosutinibTablets100mg and 500mgBosulif9/6/2016
Buprenorphine HydrochlorideBuccal Film300 mcg, 450 mcg, 600 mcg and 750 mcgBelbuca10/4/2016
Methylphenidate HydrochlorideExtended-release Capsules10 mgAptensio XR12/24/2015
Methylphenidate HydrochlorideExtended-release Capsules15 mg, 20 mg, 40 mg and 50 mgAptensio XR12/28/2015
Methylphenidate HydrochlorideExtended-release Capsules30 mgAptensio XR3/28/2016
PerampanelTablets2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mgFycompa10/24/2016
Pemetrexed DisodiumFor Injection750 mg/vialAlimta10/6/2016
RegorafenibTablets40 mgStivarga9/27/2016

Page Last Updated: 11/21/2016
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