Drugs

Paragraph IV Patent Certifications

December 16, 2014

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 NAMEDOSAGE FORMSTRENGTHRLDDATE OF SUBMISSION
AcetylcysteineInjection200 mg/mL, 30 mL vialsAcetadote4/4/2012
Lurasidone HydrochlorideTablets20 mg, 40 mg, 60 mg, 80 mg, and 120 mgLatuda10/28/2014
Micafungin SodiumFor Injection50 mg/vial and 100 mg/vialMycamine6/16/2014
Sorafenib TosylateTablets200 mgNexavar2/28/2014
ThalidomideCapsules150 mgThalomid2/3/2014
Unoprostone IsopropylOphthalmic Solution0.15%Rescula5/12/2014

Paragraph IV Patent Certifications (PDF - 2.1MB)

Page Last Updated: 12/17/2014
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