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 ten branded drugs marketed by Roche, Chartwell Molecular, Hikma, Aquestive, Bausch, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, 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, 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, Virtus, Quantum Pharmics, and Waylis Therap, and is included in ninety-one NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diazepam has one hundred and eighteen patent family members in twenty-eight countries.
There are eight drug master file entries for diazepam. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for DIAZEPAM
International Patents: | 118 |
US Patents: | 7 |
Tradenames: | 10 |
Applicants: | 40 |
NDAs: | 91 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 48 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 142 |
Patent Applications: | 6,729 |
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 Jordan | Phase 3 |
Assiut University | N/A |
Walter Reed National Military Medical Center | Phase 2 |
Generic filers with tentative approvals for DIAZEPAM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 17.5MG | FILM;BUCCAL |
⤷ Sign Up | ⤷ Sign Up | 15MG | FILM;BUCCAL |
⤷ Sign Up | ⤷ Sign Up | 12.5MG | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | DIASTAT ACUDIAL | diazepam | GEL;RECTAL | 020648-007 | Sep 15, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-002 | Jan 10, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Hikma | DIAZEPAM | diazepam | INJECTABLE;INJECTION | 070313-001 | Dec 16, 1985 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | DIAZEPAM INTENSOL | diazepam | CONCENTRATE;ORAL | 071415-001 | Apr 3, 1987 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | DIASTAT | diazepam | GEL;RECTAL | 020648-001 | Jul 29, 1997 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bausch | DIASTAT ACUDIAL | diazepam | GEL;RECTAL | 020648-006 | Sep 15, 2005 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for DIAZEPAM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-006 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-004 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Roche | VALRELEASE | diazepam | CAPSULE, EXTENDED RELEASE;ORAL | 018179-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | VALIUM | diazepam | TABLET;ORAL | 013263-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | DIASTAT ACUDIAL | diazepam | GEL;RECTAL | 020648-007 | Sep 15, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | DIASTAT ACUDIAL | diazepam | GEL;RECTAL | 020648-006 | Sep 15, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DIAZEPAM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103189068 | Compositions for drug administration | ⤷ Sign Up |
Japan | 2021193091 | 疾患の処置のための鼻腔内エピネフリン製剤及び方法 (INTRANASAL EPINEPHRINE PREPARATIONS AND METHODS FOR TREATMENT OF DISEASE) | ⤷ Sign Up |
Australia | 2011317202 | Compositions for drug administration | ⤷ Sign Up |
Canada | 2814927 | COMPOSITIONS POUR L'ADMINISTRATION DE MEDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) | ⤷ Sign Up |
China | 110505873 | 鼻内肾上腺素制剂及治疗疾病的方法 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE) | ⤷ Sign Up |
South Korea | 20200121818 | 비강내 에피네프린 제제 및 질환의 치료 방법 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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