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Last Updated: August 12, 2020

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OXAZEPAM Drug Profile

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

Oxazepam is a drug marketed by Actavis Elizabeth, Am Therap, Frontida Biopharm, Ivax Sub Teva Pharms, Mylan, Sandoz, Watson Labs, Watson Labs Teva, Parke Davis, and Sun Pharm Industries. and is included in twenty NDAs.

The generic ingredient in OXAZEPAM is oxazepam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

US ANDA Litigation and Generic Entry Outlook for Oxazepam

A generic version of OXAZEPAM was approved as oxazepam by FRONTIDA BIOPHARM on August 10th, 1987.

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Drug patent expirations by year for OXAZEPAM
Drug Prices for OXAZEPAM

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Recent Clinical Trials for OXAZEPAM

Identify potential brand extensions & 505(b)(2) entrants

National Institute on Drug Abuse (NIDA)Phase 1
Embera NeuroTherapeutics, Inc.Phase 1
National Institute on Drug Abuse (NIDA)Phase 0

See all OXAZEPAM clinical trials

Pharmacology for OXAZEPAM
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for OXAZEPAM
Paragraph IV (Patent) Challenges for OXAZEPAM
Tradename Dosage Ingredient NDA Submissiondate
SERAX TABLET;ORAL oxazepam 015539
SERAX CAPSULE;ORAL oxazepam 015539

US Patents and Regulatory Information for OXAZEPAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth OXAZEPAM oxazepam CAPSULE;ORAL 072253-002 Apr 14, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz OXAZEPAM oxazepam CAPSULE;ORAL 071814-001 Apr 19, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs OXAZEPAM oxazepam TABLET;ORAL 071494-001 Apr 21, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Frontida Biopharm OXAZEPAM oxazepam CAPSULE;ORAL 071026-002 Aug 10, 1987 AB RX No No   Start Trial   Start Trial   Start Trial
Am Therap OXAZEPAM oxazepam CAPSULE;ORAL 071955-001 Mar 3, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms OXAZEPAM oxazepam CAPSULE;ORAL 070945-001 Aug 3, 1987 DISCN No No   Start Trial   Start Trial   Start 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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