Orphenadrine citrate - Generic Drug Details
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What are the generic sources for orphenadrine citrate and what is the scope of freedom to operate?
Orphenadrine citrate
is the generic ingredient in two branded drugs marketed by Pai Holdings Pharm, Hikma, Rising, Sagent Pharms, Watson Labs, Bausch, Ascot, Lupin, Sandoz, Stevens J, and Unichem, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.Seventeen suppliers are listed for this compound.
Summary for orphenadrine citrate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,498 |
| Drug Prices: | Drug price trends for orphenadrine citrate |
| What excipients (inactive ingredients) are in orphenadrine citrate? | orphenadrine citrate excipients list |
| DailyMed Link: | orphenadrine citrate at DailyMed |
Recent Clinical Trials for orphenadrine citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Baghdad | PHASE4 |
Pharmacology for orphenadrine citrate
| Drug Class | Muscle Relaxant |
| Physiological Effect | Centrally-mediated Muscle Relaxation |
US Patents and Regulatory Information for orphenadrine citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 040249-001 | Jan 29, 1999 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Ascot | ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 088067-001 | Apr 6, 1983 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Unichem | ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 091158-001 | Jul 27, 2012 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | ORPHENADRINE CITRATE | orphenadrine citrate | INJECTABLE;INJECTION | 040463-001 | Mar 4, 2003 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sagent Pharms | ORPHENADRINE CITRATE | orphenadrine citrate | INJECTABLE;INJECTION | 090585-001 | Aug 30, 2011 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sandoz | ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 085046-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |
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