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-nine 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VALIUM?
- What are the global sales for VALIUM?
- What is Average Wholesale Price for VALIUM?
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: | 4,197 |
| 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 |
| Canadian Institutes of Health Research (CIHR) | N/A |
| Centre for Addiction and Mental Health | N/A |
Pharmacology for VALIUM
| Drug Class | Benzodiazepine |
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-006 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-004 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Roche | VALIUM | diazepam | INJECTABLE;INJECTION | 016087-001 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Subscribe |
| Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-006 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Subscribe |
| Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-004 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Subscribe |
| Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-002 | Approved Prior to Jan 1, 1982 | 4,316,897 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
