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.
Summary for GOCOVRI
| International Patents: | 18 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 106 |
| Patent Applications: | 1,448 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GOCOVRI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GOCOVRI |
| DailyMed Link: | GOCOVRI at DailyMed |
Medical Subject Heading (MeSH) Categories for GOCOVRI
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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International Patents for GOCOVRI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1845968 | ➤ Sign Up |
| Australia | 2015202356 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006058236 | ➤ Sign Up |
| Australia | 2010325960 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
