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Last Updated: August 8, 2020

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TEMAZEPAM - Generic Drug Details

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What are the generic drug sources for temazepam and what is the scope of patent protection?

Temazepam is the generic ingredient in three branded drugs marketed by Specgx Llc, Quantum Pharmics, Actavis Elizabeth, Alembic Pharms Ltd, Amneal Pharms, Duramed Pharms Barr, Mylan, Novel Labs Inc, Prinston Inc, Sandoz, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for temazepam. Twenty-nine suppliers are listed for this compound.

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
Saint-Joseph UniversityPhase 3
Massachusetts General HospitalN/A
H. Lundbeck A/SPhase 1

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Pharmacology for TEMAZEPAM
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for TEMAZEPAM
Paragraph IV (Patent) Challenges for TEMAZEPAM
Tradename Dosage Ingredient NDA Submissiondate
RESTORIL CAPSULE;ORAL temazepam 018163 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
Alembic Pharms Ltd TEMAZEPAM temazepam CAPSULE;ORAL 211542-004 Nov 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms TEMAZEPAM temazepam CAPSULE;ORAL 203482-003 May 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries TEMAZEPAM temazepam CAPSULE;ORAL 071175-001 Jul 10, 1986 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

Expired US Patents for TEMAZEPAM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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