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US FDA's New Paragraph IV Data Further Illustrates Generic Competition Problems

 
• By Derrick Gingery

Data on the number of ANDAs submitted with valid paragraph IV certifications shows some products with strong generic interest and others with almost none.

Generics
The US FDA is releasing more patent-related information for generic drug sponsors. • Source: Shutterstock

The US Food and Drug Administration's enhanced paragraph IV patent certification data continues to illustrate the varying interest of sponsors in developing generics, depending on the product.

A count of the potential first applicant ANDAs submitted, those with valid paragraph IV certifications for at least one patent...

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