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 |
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 |
Pharmacology for temazepam
| Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for temazepam
Anatomical Therapeutic Chemical (ATC) Classes for temazepam
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | TEMAZEPAM | temazepam | CAPSULE;ORAL | 211542-003 | Nov 23, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071447-001 | May 21, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071174-001 | Jul 10, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novel Labs Inc | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071457-002 | Jun 22, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Duramed Pharms Barr | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071709-001 | Sep 29, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Duramed Pharms Barr | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071708-001 | Sep 29, 1988 | 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
| 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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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.
ISSN: 2162-2639
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