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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 fourteen patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-three patent family members in seven countries.
The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Gocovri
A generic version of GOCOVRI was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.
Summary for GOCOVRI
| International Patents: | 23 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 134 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,337 |
| 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 |
Recent Clinical Trials for GOCOVRI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oregon Health and Science University | Phase 4 |
| Adamas Pharmaceuticals, Inc. | Phase 4 |
| Columbia University | Phase 4 |
Pharmacology for GOCOVRI
| Drug Class | Influenza A M2 Protein Inhibitor |
| Mechanism of Action | M2 Protein Inhibitors |
Paragraph IV (Patent) Challenges for GOCOVRI
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GOCOVRI | CAPSULE, EXTENDED RELEASE;ORAL | amantadine hydrochloride | 208944 | 2020-04-30 |
| GOCOVRI | CAPSULE, EXTENDED RELEASE;ORAL | amantadine hydrochloride | 208944 | 2018-01-16 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Adamas Pharma | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-002 | Aug 24, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Adamas Pharma | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-002 | Aug 24, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Adamas Pharma | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-001 | Aug 24, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for GOCOVRI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2013512919 | Start Trial |
| Japan | 6038203 | Start Trial |
| China | 102883601 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006058236 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
