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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, Lannett Co Inc, Hikma, Bausch, Abraxis Pharm, Beloteca Inc, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, West-ward Pharms Int, 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, Teva Pharms, Upsher Smith Labs, Vintage Pharms, Virtus Pharms, and Quantum Pharmics, and is included in eighty-five 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 sixty-five patent family members in eighteen countries.
There are eight drug master file entries for diazepam. Thirty-nine suppliers are listed for this compound.
Summary for diazepam
International Patents: | 65 |
US Patents: | 5 |
Tradenames: | 9 |
Applicants: | 34 |
NDAs: | 85 |
Drug Master File Entries: | 8 |
Suppliers / Packagers: | 39 |
Bulk Api Vendors: | 59 |
Clinical Trials: | 114 |
Patent Applications: | 6,547 |
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 |
---|---|
Ehab Tarek Fahmy | Phase 1 |
Pfizer | Phase 4 |
Queen Sirikit National Institute of Child Health | N/A |
Pharmacology for diazepam
Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for diazepam
Paragraph IV (Patent) Challenges for DIAZEPAM
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
DIASTAT ACUDIAL | GEL;RECTAL | diazepam | 020648 | 2008-12-23 |
DIASTAT | GEL;RECTAL | diazepam | 020648 | 2008-12-23 |
DIASTAT ACUDIAL | GEL;RECTAL | diazepam | 020648 | 2008-12-08 |
DIASTAT | GEL;RECTAL | diazepam | 020648 | 2008-12-08 |
DIASTAT ACUDIAL | GEL;RECTAL | diazepam | 020648 | 2004-03-23 |
DIASTAT | GEL;RECTAL | diazepam | 020648 | 2004-03-23 |
VALIUM | TABLET;ORAL | diazepam | 013263 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-005 | Jul 29, 1997 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-001 | Jan 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Dava Pharms Inc | DIAZEPAM | diazepam | TABLET;ORAL | 070228-001 | Sep 26, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-001 | Jan 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Upsher Smith Labs | DIAZEPAM | diazepam | TABLET;ORAL | 070303-001 | Dec 20, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-002 | Jan 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Watson Labs | DIAZEPAM | diazepam | INJECTABLE;INJECTION | 070930-001 | Dec 1, 1986 | DISCN | No | No | Start Trial | Start Trial | Start 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 |
---|---|---|---|---|---|---|---|
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-002 | Jul 29, 1997 | Start Trial | Start Trial |
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-003 | Jul 29, 1997 | Start Trial | Start Trial |
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-004 | Jul 29, 1997 | Start Trial | Start Trial |
Roche | VALRELEASE | diazepam | CAPSULE, EXTENDED RELEASE;ORAL | 018179-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Roche | VALIUM | diazepam | TABLET;ORAL | 013263-004 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Roche | VALIUM | diazepam | INJECTABLE;INJECTION | 016087-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-005 | Jul 29, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diazepam
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 5752048 | Start Trial |
European Patent Office | 2271347 | Start Trial |
South Korea | 20110099049 | Start Trial |
Russian Federation | 2554814 | Start Trial |
European Patent Office | 3082817 | Start Trial |
Australia | 2009228093 | Start Trial |
Japan | 2019163273 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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