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Last Updated: November 2, 2024

TEMAZEPAM Drug Patent Profile


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Which patents cover Temazepam, and what generic alternatives are available?

Temazepam is a drug marketed by Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs. and is included in twenty-one NDAs.

The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Temazepam

A generic version of TEMAZEPAM was approved as temazepam by NOVEL LABS INC on April 21st, 1987.

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Drug patent expirations by year for TEMAZEPAM
Drug Prices for TEMAZEPAM

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Drug Sales Revenue Trends for TEMAZEPAM

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Recent Clinical Trials for TEMAZEPAM

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SponsorPhase
Turku University HospitalPhase 4
Saint-Joseph UniversityPhase 3
Hannover Medical SchoolPhase 3

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Pharmacology for TEMAZEPAM
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for TEMAZEPAM
Anatomical Therapeutic Chemical (ATC) Classes for TEMAZEPAM
Paragraph IV (Patent) Challenges for TEMAZEPAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RESTORIL Capsules temazepam 7.5 mg 018163 1 2006-11-01

US Patents and Regulatory Information for TEMAZEPAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries TEMAZEPAM temazepam CAPSULE;ORAL 071174-001 Jul 10, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc TEMAZEPAM temazepam CAPSULE;ORAL 201781-002 Jun 4, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries TEMAZEPAM temazepam CAPSULE;ORAL 071175-002 Sep 14, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc TEMAZEPAM temazepam CAPSULE;ORAL 201781-003 Jun 4, 2015 AB RX 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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