Diazepam - Generic Drug Details
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What are the generic sources for diazepam and what is the scope of patent protection?
Diazepam
is the generic ingredient in nine branded drugs marketed by Roche, Chartwell Molecular, Hikma, Bausch, Novel Labs Inc, Abraxis Pharm, Beloteca, Fresenius Kabi Usa, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Pharmacia And Upjohn, Neurelis Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dava Pharms Inc, Dr Reddys Labs Sa, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, Virtus, Quantum Pharmics, and Waylis Therap, and is included in eighty-eight NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diazepam has ninety-seven patent family members in twenty-eight countries.
There are eight drug master file entries for diazepam. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for diazepam
International Patents: | 97 |
US Patents: | 6 |
Tradenames: | 9 |
Applicants: | 37 |
NDAs: | 88 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 138 |
Patent Applications: | 6,439 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
Assiut University | N/A |
Kuwait University | Early Phase 1 |
University of Guadalajara | Phase 2 |
Generic filers with tentative approvals for DIAZEPAM
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 5MG | FILM;BUCCAL |
⤷ Try a Trial | ⤷ Try a Trial | 20MG | FILM;BUCCAL |
⤷ Try a Trial | ⤷ Try a Trial | 17.5MG | FILM;BUCCAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for diazepam
Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for diazepam
Paragraph IV (Patent) Challenges for DIAZEPAM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Warner Chilcott | DIAZEPAM | diazepam | TABLET;ORAL | 070210-001 | Sep 4, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Us Army | DIAZEPAM | diazepam | INJECTABLE;INJECTION | 020124-001 | Dec 5, 1990 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Quantum Pharmics | Q-PAM | diazepam | TABLET;ORAL | 072432-001 | Apr 29, 1988 | DISCN | No | 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 diazepam
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pharmacia And Upjohn | DIZAC | diazepam | INJECTABLE;INJECTION | 019287-001 | Jun 18, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | DIASTAT ACUDIAL | diazepam | GEL;RECTAL | 020648-007 | Sep 15, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-002 | Jul 29, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diazepam
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2011516425 | ⤷ Try a Trial | |
European Patent Office | 2629786 | COMPOSITIONS POUR L'ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) | ⤷ Try a Trial |
Japan | 6883918 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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