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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 NAMEDOSAGE FORMSTRENGTHRLDDATE OF SUBMISSION
Asenapine MaleateSublingual Tablets5 mg and 10 mgSaphris8/13/2013
BuprenorphineTransdermal System5 mcg/hr, 10 mcg/hr, and 20 mcg/hrButrans6/6/2013
Calcium AcetateOral Solution667 mg/5 mLPhoslyra12/5/2013
Eltrombopag OlamineTablets50 mg and 75 mgPromacta1/7/2014
Glatiramer AcetateInjection40 mg/mL, 1 mL pre-filled syringeCopaxone2/26/2014
Hydrocodone BitartrateExtended-release Capsules10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mgZohydro ER2/26/2014
NicotineTransdermal System7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrsNicoderm CQ5/30/2014
TacrolimusExtended-release Capsules0.5 mg, 1 mg, and 5 mgAstagraf XL11/15/2013
TopiramateExtended-release Capsules200 mgTrokendi XR4/3/2014

Paragraph IV Patent Certifications (PDF - 2MB)