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FDA Adds Transparency On Paragraph IVs In Bid To Spur Competition

 
• By Aidan Fry

By disclosing when the first paragraph IV patent challenges were filed, how many players are in the race, and whether it has decided on eligibility for 180-day exclusivity, the FDA is aiming to spur greater competition in the US generics arena.

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The FDA is offering greater transparency on pargraph IV patent challenges is a bid to spur greater generic competition • Source: Shutterstock

Decisions on 180-day generic market exclusivity, the number of potential first applicants qualifying for such exclusivity, the date of approval for the first applicant or applicants, the date of first commercial marketing, and the expiration date of last qualifying patent will henceforth all be added to the database of paragraph IV patent certifications published by the US Food and Drug Administration.

Acting FDA commissioner Ned Sharpless said the improvements to “one of the agency’s most viewed databases for industry” would “improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower-cost generic drugs

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