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 21^st, 1987.

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Summary for RESTORIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	2
Patent Applications:	5,415
Drug Prices:	Drug price information for RESTORIL
What excipients (inactive ingredients) are in RESTORIL?	RESTORIL excipients list
DailyMed Link:	RESTORIL at DailyMed

Drug patent expirations by year for RESTORIL

Recent Clinical Trials for RESTORIL

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

Sponsor	Phase
Massachusetts General Hospital	N/A
State University of New York - Upstate Medical University	Phase 2

See all RESTORIL clinical trials

Pharmacology for RESTORIL

Drug Class	Benzodiazepine

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

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Glossary

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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

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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.

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Country	Patent Number	Title	Estimated Expiration
Japan	S63101325	PHARMACOLOGICAL COMPOSITION CONTAINING BENZODIAZEPINE DERIVATIVE	⤷ Sign Up
Germany	3731840		⤷ Sign Up
Italy	1221509	COMPOSIZIONE FARMACEUTICA CONTENENTE UN DERIVATO BENZODIAZEPINICO	⤷ Sign Up
Canada	1302886	COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE LA BENZODIAZEPINE (PHARMACEUTICAL COMPOSITION CONTAINING A BENZODIAZEPIN DERIVATIVE)	⤷ Sign Up
Italy	8748408		⤷ Sign Up
Switzerland	673947		⤷ Sign Up
Belgium	1000318	NOUVELLES COMPOSITIONS PHARMACEUTIQUES A BASE D'UN DERIVE DE LA BENZODIAZEPINE.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration