Paragraph IV Patent Certifications

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As of September 17, 2012

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 Regulatory Support Branch at 240-276-8400, before making any decisions based on this information.

New:

Paragraph IV Patent Certifications (PDF - 1.25 MB) 

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Oxycodone Hydrochloride	Tablets	5 mg and 7.5 mg	Oxecta	2/8/2012
Regadenoson	Injection	0.08 mg/mL, 5 mL vial	Lexiscan	4/10/2012
Tenofovir Disoproxil Fumarate	Tablets	150 mg, 200 mg, and 250 mg	Viread	5/17/2012

• FDA News: FDA announces measures to improve generic drug access
• Docket # 2000P-1556   Policy regarding ANDA holder confidentiality