AMANTADINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Amantadine Hydrochloride, and when can generic versions of Amantadine Hydrochloride launch?
Amantadine Hydrochloride is a drug marketed by Zydus, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Rising, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, Endo Operations, G And W Labs Inc, Pharm Assoc, Teva Pharms, Xttrium Labs Inc, Adaptis, Athem, Jubilant Generics, and Zhejiang Jutai Pharm. and is included in thirty-six NDAs.
The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amantadine Hydrochloride
A generic version of AMANTADINE HYDROCHLORIDE was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.
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Summary for AMANTADINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 29 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 154 |
| Clinical Trials: | 114 |
| Patent Applications: | 1,822 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMANTADINE HYDROCHLORIDE |
| DailyMed Link: | AMANTADINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for AMANTADINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ohio State University | Phase 1 |
| Ain Shams University | Phase 3 |
| Shahid Beheshti University of Medical Sciences | Phase 2 |
Pharmacology for AMANTADINE HYDROCHLORIDE
| Drug Class | Influenza A M2 Protein Inhibitor |
| Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for AMANTADINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for AMANTADINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for AMANTADINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GOCOVRI | Extended-release Capsules | amantadine hydrochloride | 68.5 mg | 208944 | 1 | 2020-04-30 |
| GOCOVRI | Extended-release Capsules | amantadine hydrochloride | 137 mg | 208944 | 1 | 2018-01-16 |
US Patents and Regulatory Information for AMANTADINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jubilant Generics | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 210403-001 | Feb 7, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Adaptis | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 212407-001 | May 27, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 209035-001 | Jun 9, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | TABLET;ORAL | 214284-001 | Oct 15, 2020 | AB | RX | No | No | ⤷ 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 |
