PROPOXYPHENE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for propoxyphene hydrochloride and what is the scope of patent protection?
Propoxyphene hydrochloride
is the generic ingredient in six branded drugs marketed by Xanodyne Pharm, Heritage Pharms Inc, Mk Labs, Halsey, Alra, Impax Labs, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Nexgen Pharma Inc, Par Pharm, Purepac Pharm, Pvt Form, Roxane, Sandoz, Teva, Valeant Pharm Intl, Vintage Pharms, Watson Labs, West Ward, Whiteworth Town Plsn, and Warner Chilcott, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for propoxyphene hydrochloride.
Summary for PROPOXYPHENE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 22 |
| NDAs: | 30 |
| Drug Master File Entries: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 24 |
| Clinical Trials: | 8 |
| Patent Applications: | 3,128 |
| What excipients (inactive ingredients) are in PROPOXYPHENE HYDROCHLORIDE? | PROPOXYPHENE HYDROCHLORIDE excipients list |
| DailyMed Link: | PROPOXYPHENE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PROPOXYPHENE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mansoura University | Phase 1/Phase 2 |
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
US Patents and Regulatory Information for PROPOXYPHENE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | PROPOXYPHENE HYDROCHLORIDE | propoxyphene hydrochloride | CAPSULE;ORAL | 040569-001 | Dec 16, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | PROPOXYPHENE HYDROCHLORIDE | propoxyphene hydrochloride | CAPSULE;ORAL | 085190-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | PROPOXYPHENE HYDROCHLORIDE | propoxyphene hydrochloride | CAPSULE;ORAL | 080908-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vintage Pharms | PROPOXYPHENE HYDROCHLORIDE | propoxyphene hydrochloride | CAPSULE;ORAL | 040908-001 | Jul 17, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pvt Form | PROPOXYPHENE HYDROCHLORIDE | propoxyphene hydrochloride | CAPSULE;ORAL | 083113-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roxane | PROPOXYPHENE HYDROCHLORIDE | propoxyphene hydrochloride | CAPSULE;ORAL | 083089-001 | 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 |
