DIAZEPAM Drug Patent Profile
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Which patents cover Diazepam, and what generic alternatives are available?
Diazepam is a drug marketed by Chartwell Molecular, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Endo Operations, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, and Virtus. and is included in seventy-eight NDAs.
The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the diazepam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diazepam
A generic version of DIAZEPAM was approved as diazepam by MYLAN on September 4th, 1985.
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Questions you can ask:
- What is the 5 year forecast for DIAZEPAM?
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- What is Average Wholesale Price for DIAZEPAM?
Summary for DIAZEPAM
| US Patents: | 0 |
| Applicants: | 33 |
| NDAs: | 78 |
| Finished Product Suppliers / Packagers: | 43 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 142 |
| Patent Applications: | 4,166 |
| Drug Prices: | Drug price information for DIAZEPAM |
| Drug Sales Revenues: | Drug sales revenues for DIAZEPAM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIAZEPAM |
| What excipients (inactive ingredients) are in DIAZEPAM? | DIAZEPAM excipients list |
| DailyMed Link: | DIAZEPAM at DailyMed |
Recent Clinical Trials for DIAZEPAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Jordan | Phase 3 |
| Assiut University | N/A |
| Walter Reed National Military Medical Center | Phase 2 |
Pharmacology for DIAZEPAM
| Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for DIAZEPAM
Anatomical Therapeutic Chemical (ATC) Classes for DIAZEPAM
Paragraph IV (Patent) Challenges for DIAZEPAM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VALTOCO | Nasal Spray | diazepam | 10 mg/spray | 211635 | 1 | 2024-02-14 |
| DIASTAT ACUDIAL | Rectal Gel | diazepam | 5 mg/mL, 2mL pre-filled syringe | 020648 | 1 | 2008-12-23 |
| DIASTAT ACUDIAL | Rectal Gel | diazepam | 5 mg/mL, 4mL pre- filled syringe | 020648 | 1 | 2008-12-08 |
| DIASTAT ACUDIAL | Rectal Gel | diazepam | 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL 15 mg/3 mL 20 mg/4 mL | 020648 | 1 | 2004-03-23 |
US Patents and Regulatory Information for DIAZEPAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nuvo Pharm | DIAZEPAM | diazepam | TABLET;ORAL | 070464-001 | Feb 25, 1986 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Barr | DIAZEPAM | diazepam | TABLET;ORAL | 070154-001 | Nov 1, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Molecular | DIAZEPAM | diazepam | SOLUTION;ORAL | 206477-001 | Jun 24, 2016 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Warner Chilcott | DIAZEPAM | diazepam | TABLET;ORAL | 070210-001 | Sep 4, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Duramed Pharms Barr | DIAZEPAM | diazepam | TABLET;ORAL | 070895-001 | Aug 27, 1986 | 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 |
