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Last Updated: November 29, 2022

Temazepam - Generic Drug Details


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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, Aurobindo Pharma Usa, Duramed Pharms Barr, 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-five suppliers are listed for this compound.

Drug Prices for temazepam

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Drug Sales Revenue Trends for temazepam

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Recent Clinical Trials for temazepam

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SponsorPhase
Turku University HospitalPhase 4
Saint-Joseph UniversityPhase 3
Hannover Medical SchoolPhase 3

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Pharmacology for temazepam
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for temazepam
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms TEMAZEPAM temazepam CAPSULE;ORAL 203482-004 May 23, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Usa TEMAZEPAM temazepam CAPSULE;ORAL 070920-003 Jun 12, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs TEMAZEPAM temazepam CAPSULE;ORAL 071446-001 May 21, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 See Plans and Pricing See Plans and Pricing
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.