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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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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

More from Biosimilars & Generics

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).