OXANDROLONE - Generic Drug Details
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What are the generic 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. Two suppliers are 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: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 23 |
Patent Applications: | 4,107 |
Formulation / Manufacturing: | see details |
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 |
Sunnybrook Health Sciences Centre | Phase 3 |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upsher Smith Labs | OXANDROLONE | oxandrolone | TABLET;ORAL | 078033-001 | Mar 22, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Pharm | OXANDROLONE | oxandrolone | TABLET;ORAL | 077827-001 | Jun 22, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Upsher Smith Labs | OXANDROLONE | oxandrolone | TABLET;ORAL | 076761-001 | Dec 1, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | OXANDROLONE | oxandrolone | TABLET;ORAL | 076897-002 | Dec 1, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |