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 21st, 1987.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for RESTORIL?
- What are the global sales for RESTORIL?
- What is Average Wholesale Price for RESTORIL?
Summary for RESTORIL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 2 |
Patent Applications: | 4,095 |
Drug Prices: | Drug price information for RESTORIL |
What excipients (inactive ingredients) are in RESTORIL? | RESTORIL excipients list |
DailyMed Link: | RESTORIL at DailyMed |
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 |
Pharmacology for RESTORIL
Drug Class | Benzodiazepine |
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 | ⤷ 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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Italy | 1221509 | COMPOSIZIONE FARMACEUTICA CONTENENTE UN DERIVATO BENZODIAZEPINICO | ⤷ Sign Up |
Japan | S63101325 | PHARMACOLOGICAL COMPOSITION CONTAINING BENZODIAZEPINE DERIVATIVE | ⤷ Sign Up |
United Kingdom | 8722205 | ⤷ Sign Up | |
Canada | 1302886 | COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE LA BENZODIAZEPINE (PHARMACEUTICAL COMPOSITION CONTAINING A BENZODIAZEPIN DERIVATIVE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |