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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
Julphar
Mallinckrodt
Teva
McKinsey
Daiichi Sankyo
UBS
Johnson and Johnson

Generated: August 22, 2018

DrugPatentWatch Database Preview

GOCOVRI Drug Profile

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When do Gocovri patents expire, and what generic alternatives are available?

Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in seven countries.

The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

US Patents and Regulatory Information for GOCOVRI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for GOCOVRI
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 137 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for GOCOVRI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,987,333 Composition and method for treating neurological disease ➤ Sign Up
9,072,697 Composition and method for treating neurological disease ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
Julphar
Mallinckrodt
Teva
McKinsey
Daiichi Sankyo
UBS
Johnson and Johnson

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