Paragraph IV Patent Certifications

As of May 6, 2013

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:

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Drospirenone and Ethinyl Estradiol and Levomefolate Calcium and Levomefolate Calcium	Tablets	3 mg/0.03 mg/0.451 mg and 0.451 mg	Safyral	9/28/2012
Fesoterodine Fumarate	Extended-release Tablets	4 mg and 8 mg	Toviaz	10/31/2012
Imiquimod	Cream	3.75%	Zyclara	8/8/2012
Phentermine Hydrochloride	Orally Disintegrating Tablets	15 mg and 30 mg	Suprenza	10/19/2012
Ritonavir	Capsules	100 mg	Norvir	10/31/2012
Silodosin	Capsules	4 mg and 8 mg	Rapaflo	10/9/2012
Timolol Maleate	Ophthalmic Solution	0.5%	Istalol	10/19/2012
Treprostinil Sodium	Injection	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial	Remodulin	12/7/2012

Paragraph IV Patent Certifications (PDF - 1.3 MB)