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U.S. Department of Health and Human Services

Drugs

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Paragraph IV Patent Certifications

August 19, 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 NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION
Asenapine Maleate Sublingual Tablets 5 mg and 10 mg Saphris 8/13/2013
Buprenorphine Transdermal System 5 mcg/hr, 10 mcg/hr, and 20 mcg/hr Butrans 6/6/2013
Calcium Acetate Oral Solution 667 mg/5 mL Phoslyra 12/5/2013
Eltrombopag Olamine Tablets 50 mg and 75 mg Promacta 1/7/2014
Glatiramer Acetate Injection 40 mg/mL, 1 mL pre-filled syringe Copaxone 1/29/2014
Hydrocodone Bitartrate Extended-release Capsules 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg Zohydro ER 2/26/2014
Nicotine Transdermal System 7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs Nicoderm CQ 5/30/2014
Tacrolimus Extended-release Capsules 0.5 mg, 1 mg, and 5 mg Astagraf XL 11/15/2013
Topiramate Extended-release Capsules 200 mg Trokendi XR 4/3/2014

Paragraph IV Patent Certifications (PDF - 2MB)