DrugPatentWatch Database Preview
Diazepam - Generic Drug Details
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 fifty-one patent family members in thirteen countries.
There are eight drug master file entries for diazepam. Forty suppliers are listed for this compound.
Summary for diazepam
| International Patents: | 51 |
| US Patents: | 5 |
| Tradenames: | 9 |
| Applicants: | 34 |
| NDAs: | 85 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 40 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 107 |
| Patent Applications: | 6,393 |
| 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 |
| DailyMed Link: | diazepam at DailyMed |
Recent Clinical Trials for diazepam
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Queen Sirikit National Institute of Child Health | N/A |
| TriHealth Inc. | Phase 4 |
| Swedish Medical Center | Phase 4 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Elizabeth | DIAZEPAM | diazepam | TABLET;ORAL | 070706-001 | Mar 19, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Quantum Pharmics | Q-PAM | diazepam | TABLET;ORAL | 072432-001 | Apr 29, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mayne Pharma | DIAZEPAM | diazepam | TABLET;ORAL | 071135-001 | Feb 3, 1987 | AB | RX | 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 | 020648-005 | 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 |
| Pharmacia And Upjohn | DIZAC | diazepam | INJECTABLE;INJECTION | 019287-001 | Jun 18, 1993 | 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 | 2011516425 | Start Trial |
| Denmark | 2720699 | Start Trial |
| European Patent Office | 2271347 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2020 - 2021
NCE-1 Patent Challenge Dates 2020 - 2021
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
