Paragraph IV Patent Certifications

June 21, 2016

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 Division of Filing Review at 240-402-8859, before making any decisions based on this information.

Drug NameDosage FormStrengthRLDDate of Submission
Adapalene and Benzoyl PeroxideGel0.3%/2.5%Epiduo Forte5/4/2016
AvanafilTablets50 mg, 100 mg and 200 mgStendra4/27/2016
Benzyl AlcoholLotion5%Ulesfia4/11/2016
Methylphenidate HydrochlorideExtended-release Chewable Tablets20 mg, 30 mg and 40 mgQuillchew ER4/25/2016


Page Last Updated: 06/23/2016
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