Orphenadrine hydrochloride - Generic Drug Details
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What are the generic drug sources for orphenadrine hydrochloride and what is the scope of freedom to operate?
Orphenadrine hydrochloride
is the generic ingredient in one branded drug marketed by 3M and is included in one NDA. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for orphenadrine hydrochloride.
Summary for orphenadrine hydrochloride
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 12 |
Patent Applications: | 79 |
DailyMed Link: | orphenadrine hydrochloride at DailyMed |
Recent Clinical Trials for orphenadrine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Petrovsky National Research Centre of Surgery | N/A |
University of Puerto Rico | Phase 4 |
Ache Laboratorios Farmaceuticos S.A. | Phase 3 |
US Patents and Regulatory Information for orphenadrine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
3m | DISIPAL | orphenadrine hydrochloride | TABLET;ORAL | 010653-001 | Approved Prior to Jan 1, 1982 | 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 |