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. 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

See drug prices for OXANDROLONE

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

See all OXANDROLONE clinical trials

Medical Subject Heading (MeSH) Categories for OXANDROLONE

Anabolic Agents
Androgens

Anatomical Therapeutic Chemical (ATC) Classes for OXANDROLONE

A14AA	Androstan derivatives
A14A	ANABOLIC STEROIDS
A14	ANABOLIC AGENTS FOR SYSTEMIC USE
A	Alimentary tract and metabolism

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

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Glossary

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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
>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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