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, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for temazepam

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	24
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	9
Patent Applications:	6,637
Drug Prices:	Drug price trends for temazepam
Drug Sales Revenues:	Drug sales revenues for temazepam
What excipients (inactive ingredients) are in temazepam?	temazepam excipients list
DailyMed Link:	temazepam at DailyMed

See drug prices for temazepam

See drug sales revenues for temazepam

Recent Clinical Trials for temazepam

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

Sponsor	Phase
Turku University Hospital	Phase 4
Saint-Joseph University	Phase 3
Hannover Medical School	Phase 3

See all temazepam clinical trials

Pharmacology for temazepam

Drug Class	Benzodiazepine

Medical Subject Heading (MeSH) Categories for temazepam

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for temazepam

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TEMAZEPAM

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 temazepam

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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
Alkem Labs Ltd	TEMAZEPAM	temazepam	CAPSULE;ORAL	217875-002	Aug 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	TEMAZEPAM	temazepam	CAPSULE;ORAL	217875-004	Aug 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	TEMAZEPAM	temazepam	CAPSULE;ORAL	201781-001	Jun 4, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	TEMAZEPAM	temazepam	CAPSULE;ORAL	078581-001	Sep 8, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	TEMAZEPAM	temazepam	CAPSULE;ORAL	070920-003	Jun 12, 2009		DISCN	No	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 temazepam

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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

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