Rimantadine hydrochloride - Generic Drug Details
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What are the generic sources for rimantadine hydrochloride and what is the scope of freedom to operate?
Rimantadine hydrochloride
is the generic ingredient in two branded drugs marketed by Forest Labs, Sun Pharm Inds Inc, Chartwell Rx, Impax Labs, and Impax Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for rimantadine hydrochloride. One supplier is listed for this compound.
Summary for rimantadine hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 149 |
Clinical Trials: | 6 |
Patent Applications: | 2,036 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in rimantadine hydrochloride? | rimantadine hydrochloride excipients list |
DailyMed Link: | rimantadine hydrochloride at DailyMed |
Recent Clinical Trials for rimantadine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Oxford | Phase 2/Phase 3 |
The Leeds Teaching Hospitals NHS Trust | |
Cancer Research UK |
Pharmacology for rimantadine hydrochloride
Drug Class | Influenza A M2 Protein Inhibitor |
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for rimantadine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for rimantadine hydrochloride
US Patents and Regulatory Information for rimantadine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Impax Labs Inc | RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 075916-001 | Nov 2, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Inc | FLUMADINE | rimantadine hydrochloride | TABLET;ORAL | 019649-001 | Sep 17, 1993 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chartwell Rx | RIMANTADINE HYDROCHLORIDE | rimantadine hydrochloride | TABLET;ORAL | 076375-001 | Jan 14, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Forest Labs | FLUMADINE | rimantadine hydrochloride | SYRUP;ORAL | 019650-001 | Sep 17, 1993 | DISCN | 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 |
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