VALIUM Drug Patent Profile
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Which patents cover Valium, and what generic alternatives are available?
Valium is a drug marketed by Roche and Waylis Therap and is included in two NDAs.
The generic ingredient in VALIUM is diazepam. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diazepam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Valium
A generic version of VALIUM was approved as diazepam by MYLAN on September 4th, 1985.
Summary for VALIUM
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 46 |
Patent Applications: | 4,133 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VALIUM |
What excipients (inactive ingredients) are in VALIUM? | VALIUM excipients list |
DailyMed Link: | VALIUM at DailyMed |
Recent Clinical Trials for VALIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mayo Clinic | Phase 1/Phase 2 |
Ontario Ministry of Health and Long Term Care | N/A |
Canadian Institutes of Health Research (CIHR) | N/A |
Pharmacology for VALIUM
Drug Class | Benzodiazepine |
Anatomical Therapeutic Chemical (ATC) Classes for VALIUM
US Patents and Regulatory Information for VALIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Roche | VALIUM | diazepam | INJECTABLE;INJECTION | 016087-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-006 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-004 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 VALIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-004 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | VALIUM | diazepam | INJECTABLE;INJECTION | 016087-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-006 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |