➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Medtronic
Express Scripts
Colorcon
Mallinckrodt

Last Updated: March 2, 2021

DrugPatentWatch Database Preview

Temazepam - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for temazepam and what is the scope of freedom to operate?

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-six suppliers are listed for this compound.

Drug Prices for temazepam

See drug prices for temazepam

Drug Sales Revenue Trends for temazepam

See drug sales revenues for temazepam

Recent Clinical Trials for temazepam

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

SponsorPhase
Saint-Joseph UniversityPhase 3
Massachusetts General HospitalN/A
University of SurreyPhase 1

See all temazepam clinical trials

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
Novel Labs Inc TEMAZEPAM temazepam CAPSULE;ORAL 071457-001 Apr 21, 1987 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz TEMAZEPAM temazepam CAPSULE;ORAL 071427-001 Jan 12, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs TEMAZEPAM temazepam CAPSULE;ORAL 071446-001 May 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Usl Pharma TEMAZEPAM temazepam CAPSULE;ORAL 070490-001 Jul 7, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms TEMAZEPAM temazepam CAPSULE;ORAL 203482-004 May 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc TEMAZEPAM temazepam CAPSULE;ORAL 201781-003 Jun 4, 2015 AB RX 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Colorcon
Mallinckrodt
Harvard Business School
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.