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Last Updated: March 18, 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-six 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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Drug patent expirations by year for RESTORIL
Drug Prices for RESTORIL

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Recent Clinical Trials for RESTORIL

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

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Pharmacology for RESTORIL
Drug ClassBenzodiazepine
Anatomical Therapeutic Chemical (ATC) Classes for RESTORIL
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 RESTORIL

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

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