Oxandrolone - Generic Drug Details
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What are the generic drug sources for oxandrolone and what is the scope of freedom to operate?
Oxandrolone
is the generic ingredient in one branded drug marketed by Par Pharm, Roxane, Sandoz, and Upsher Smith Labs, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for oxandrolone. One supplier is listed for this compound.
Summary for oxandrolone
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 10 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 23 |
| Patent Applications: | 4,107 |
| Drug Prices: | Drug price trends for oxandrolone |
| What excipients (inactive ingredients) are in oxandrolone? | oxandrolone excipients list |
| DailyMed Link: | oxandrolone at DailyMed |
Recent Clinical Trials for oxandrolone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| George F. Hatch | Phase 4 |
| University Hospital, Clermont-Ferrand | Phase 2 |
| United States Department of Defense | Phase 3 |
Medical Subject Heading (MeSH) Categories for oxandrolone
Anatomical Therapeutic Chemical (ATC) Classes for oxandrolone
Paragraph IV (Patent) Challenges for OXANDROLONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OXANDRIN | Tablets | oxandrolone | 2.5 mg and 10 mg | 013718 | 1 | 2006-06-19 |
US Patents and Regulatory Information for oxandrolone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roxane | OXANDROLONE | oxandrolone | TABLET;ORAL | 077249-002 | Jul 10, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | OXANDROLONE | oxandrolone | TABLET;ORAL | 076897-002 | Dec 1, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Par Pharm | OXANDROLONE | oxandrolone | TABLET;ORAL | 077827-002 | Jun 22, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roxane | OXANDROLONE | oxandrolone | TABLET;ORAL | 077249-001 | Jul 10, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Par Pharm | OXANDROLONE | oxandrolone | TABLET;ORAL | 077827-001 | Jun 22, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | OXANDROLONE | oxandrolone | TABLET;ORAL | 076761-001 | Dec 1, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | OXANDROLONE | oxandrolone | TABLET;ORAL | 078033-001 | Mar 22, 2007 | 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 |
