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Last Updated: March 19, 2024

OXANDROLONE Drug Patent Profile


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When do Oxandrolone patents expire, and when can generic versions of Oxandrolone launch?

Oxandrolone is a drug marketed by Par Pharm, Roxane, Sandoz, and Upsher Smith Labs. and is included in five NDAs.

The generic ingredient in OXANDROLONE is oxandrolone. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.

Drug patent expirations by year for OXANDROLONE
Drug Prices for OXANDROLONE

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Recent Clinical Trials for OXANDROLONE

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SponsorPhase
University Hospital, Clermont-FerrandPhase 2
George F. HatchPhase 4
Sunnybrook Health Sciences CentrePhase 3

See all OXANDROLONE clinical trials

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
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
Roxane OXANDROLONE oxandrolone TABLET;ORAL 077249-002 Jul 10, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 077827-002 Jun 22, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane OXANDROLONE oxandrolone TABLET;ORAL 077249-001 Jul 10, 2007 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

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