AMANTADINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for amantadine hydrochloride and what is the scope of freedom to operate?
Amantadine hydrochloride
is the generic ingredient in five branded drugs marketed by Adamas Operations, 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, Solvay, Endo Pharms, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, G And W Labs Inc, Genus, Pharm Assoc, Teva Pharms, Vintage, Xttrium Labs Inc, Athem, Edenbridge Pharms, and Jubilant Generics, and is included in forty NDAs. There are twenty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amantadine hydrochloride has forty-five patent family members in eleven countries.
There are five drug master file entries for amantadine hydrochloride. Thirty-one suppliers are listed for this compound.
Summary for AMANTADINE HYDROCHLORIDE
International Patents: | 45 |
US Patents: | 28 |
Tradenames: | 5 |
Applicants: | 31 |
NDAs: | 40 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 31 |
Raw Ingredient (Bulk) Api Vendors: | 154 |
Clinical Trials: | 112 |
Patent Applications: | 2,684 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMANTADINE HYDROCHLORIDE |
What excipients (inactive ingredients) are in AMANTADINE HYDROCHLORIDE? | AMANTADINE HYDROCHLORIDE excipients list |
DailyMed Link: | AMANTADINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for AMANTADINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shahid Beheshti University of Medical Sciences | Phase 2 |
Hospital San Carlos, Madrid | Phase 3 |
University Hospital Tuebingen | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 074028-001 | Jun 28, 1993 | AA | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-004 | Apr 22, 2020 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AMANTADINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMANTADINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2549581 | ⤷ Try a Trial | |
European Patent Office | 3132793 | COMPOSITIONS D'AMANTADINE ET PROCÉDÉS D'UTILISATION (AMANTADINE COMPOSITIONS AND METHODS OF USE) | ⤷ Try a Trial |
Australia | 2015202356 | Amantadine compositions and methods of use | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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