Diazepam - Generic Drug Details
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What are the generic drug sources for diazepam and what is the scope of freedom to operate?
Diazepam
is the generic ingredient in nine branded drugs marketed by Roche, Chartwell Molecular, Hikma, Bausch, Abraxis Pharm, Beloteca Inc, 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, Barr, Dava Pharms Inc, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mayne Pharma, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, Upsher Smith Labs, Virtus Pharms, Quantum Pharmics, and Waylis Therap, and is included in eighty-six NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diazepam has eighty-four patent family members in twenty-three countries.
There are eight drug master file entries for diazepam. Forty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for diazepam
International Patents: | 84 |
US Patents: | 5 |
Tradenames: | 9 |
Applicants: | 35 |
NDAs: | 86 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 135 |
Patent Applications: | 6,480 |
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 |
---|---|
University of Guadalajara | Phase 2 |
Institute of Experimental and Clinical Therapeutics | Phase 2 |
Hospital Civil de Guadalajara | Phase 2 |
Generic filers with tentative approvals for DIAZEPAM
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 10MG | FILM;BUCCAL |
See Plans and Pricing | See Plans and Pricing | 7.5MG | FILM;BUCCAL |
See Plans and Pricing | See Plans and Pricing | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-001 | Jan 10, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Pharmacia And Upjohn | DIZAC | diazepam | INJECTABLE;INJECTION | 019287-001 | Jun 18, 1993 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Hospira | DIAZEPAM | diazepam | INJECTABLE;INJECTION | 072079-001 | Dec 20, 1988 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Ivax Sub Teva Pharms | DIAZEPAM | diazepam | TABLET;ORAL | 071322-001 | Dec 10, 1986 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mylan | DIAZEPAM | diazepam | TABLET;ORAL | 070325-002 | Sep 4, 1985 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Beloteca Inc | DIAZEPAM | diazepam | INJECTABLE;INJECTION | 210363-001 | Mar 18, 2019 | AP | RX | No | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 |
---|---|---|---|---|---|---|---|
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-004 | Jul 29, 1997 | See Plans and Pricing | See Plans and Pricing |
Roche | VALRELEASE | diazepam | CAPSULE, EXTENDED RELEASE;ORAL | 018179-001 | Approved Prior to Jan 1, 1982 | See Plans and Pricing | See Plans and Pricing |
Pharmacia And Upjohn | DIZAC | diazepam | INJECTABLE;INJECTION | 019287-001 | Jun 18, 1993 | See Plans and Pricing | See Plans and Pricing |
Roche | VALIUM | diazepam | INJECTABLE;INJECTION | 016087-001 | Approved Prior to Jan 1, 1982 | See Plans and Pricing | See Plans and Pricing |
Bausch | DIASTAT ACUDIAL | diazepam | GEL;RECTAL | 020648-006 | Sep 15, 2005 | See Plans and Pricing | See Plans and Pricing |
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-005 | Jul 29, 1997 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diazepam
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2791775 | FORMULACIONES DE EPINEFRINA INTRANASAL Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE) | See Plans and Pricing |
Denmark | 2720699 | See Plans and Pricing | |
European Patent Office | 2720699 | ADMINISTRATION DE BENZODIAZÉPINE (ADMINISTRATION OF BENZODIAZEPINE) | See Plans and Pricing |
Canada | 2814927 | COMPOSITIONS POUR L'ADMINISTRATION DE MEDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) | See Plans and Pricing |
China | 103189068 | Compositions for drug administration | See Plans and Pricing |
Mexico | 2011006790 | COMPOSICIONES PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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