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Last Updated: November 2, 2024

RESTORIL Drug Patent Profile


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

Restoril is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in RESTORIL 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 Restoril

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

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Summary for RESTORIL
Drug patent expirations by year for RESTORIL
Drug Prices for RESTORIL

See drug prices for RESTORIL

Recent Clinical Trials for RESTORIL

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

SponsorPhase
Massachusetts General HospitalN/A
State University of New York - Upstate Medical UniversityPhase 2

See all RESTORIL clinical trials

Pharmacology for RESTORIL
Drug ClassBenzodiazepine
Paragraph IV (Patent) Challenges for RESTORIL
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 RESTORIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-004 Nov 2, 2004 AB RX Yes 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

Expired US Patents for RESTORIL

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

International Patents for RESTORIL

See the table below for patents covering RESTORIL around the world.

Country Patent Number Title Estimated Expiration
Italy 1221509 COMPOSIZIONE FARMACEUTICA CONTENENTE UN DERIVATO BENZODIAZEPINICO ⤷  Sign Up
Japan S63101325 PHARMACOLOGICAL COMPOSITION CONTAINING BENZODIAZEPINE DERIVATIVE ⤷  Sign Up
United Kingdom 8722205 ⤷  Sign Up
Canada 1302886 COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE LA BENZODIAZEPINE (PHARMACEUTICAL COMPOSITION CONTAINING A BENZODIAZEPIN DERIVATIVE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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