A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Diazepam's patents.
Latest Legal Activities on Diazepam's Patents
Given below is the list recent legal activities going on the following patents of Diazepam.
Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List
Diazepam Generic API Manufacturers
Several generic applications have been filed for Diazepam. The first generic version for Diazepam was by Mylan Pharmaceuticals Inc and was approved on Sep 4, 1985. And the latest generic version is by Nuvo Pharmaceutical Inc and was approved on Sep 10, 2024.
Given below is the list of companies who have filed for
Diazepam generic, along with the locations of their manufacturing plants worldwide.
1. ABRAXIS PHARM
Abraxis Pharmaceutical Products has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Abraxis Pharm.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
injectable
Discontinued
INJECTION
N/A
Jun 25, 1986
2. ACTAVIS ELIZABETH
Actavis Elizabeth Llc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Actavis Elizabeth.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Discontinued
ORAL
N/A
Mar 19, 1986
10MG
tablet
Discontinued
ORAL
N/A
Mar 19, 1986
5MG
tablet
Discontinued
ORAL
N/A
Mar 19, 1986
Manufacturing Plant Locations
New
Actavis Elizabeth's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Elizabeth as present at those locations.
Country
City
Firm Name
United States
Elizabeth
Actavis Elizabeth LLC, A Company of Teva
3. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Alembic.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/2ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Apr 25, 2024
Manufacturing Plant Locations
New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Aurobindo Pharma Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Prescription
ORAL
AB
Dec 14, 2023
5MG
tablet
Prescription
ORAL
AB
Dec 14, 2023
10MG
tablet
Prescription
ORAL
AB
Dec 14, 2023
Manufacturing Plant Locations
New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
Country
City
Firm Name
India
Medchal
Aurobindo Pharma Ltd
5. BARR
Barr Laboratories Inc has filed for 2 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Barr.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Discontinued
ORAL
N/A
Nov 1, 1985
10MG
tablet
Discontinued
ORAL
N/A
Nov 1, 1985
Manufacturing Plant Locations
New
Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.
Country
City
Firm Name
Mexico
Aldama
Barra La Coma, S. De R.L
Singapore
Singapore
Barramundi Asia Pte Ltd
United States
Somerset
Barrett Distribution Centers Inc
Englewood
Barrett E. Cowan, MD
Curtis Bay
Barrett Distribution Center
Hereford
Barrett and Crofoot Feedyard, West
Forest
Barr Laboratories Inc.
Arecibo
Barreto Dairy, Inc.
Barrett
Barrett Farm Supply, Inc.
Randolph
Barrett Farm
Davie
Barrier Technologies LLC
Belvidere
Barred Woods, LLC
Harrison
Barrington Chemical Corporation
Franklin
Barrett Distribution Centers, Inc.
Lee
Barrington Coffee Roasting Company, Inc.
Buffalo
Barrel and Brine Inc
Commerce
Barreras Meat Co
Live Oak
Barrington Dairy Farm
Newton
Barrett Technology, LLC
Memphis
Barrett Distribution Centers
Swartz Creek
Barrett Donut Mixes, Inc..
Paso Robles
Barreto Cellars
Lake Barrington
Barrington Ventures, Ltd
Greenwood
Barr Enterprises, Inc.
Hereford
Barrett and Crofoot, LLP
Machipongo
Barrier Island Seafood
Dillon
Barretts Minerals Inc
Brainerd
Barrett Ag Service, Inc.
Montezuma
Barrington Dairies
Madison
Barriques Holding Company, LLC
Philippines
Bulacan
Barrio Fiesta Manufacturing Corporation
6. BELOTECA
Beloteca Inc has filed for 2 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Beloteca.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/2ML (5MG/ML)
(reference standard)
injectable
Prescription
INJECTION
AP
Mar 18, 2019
50MG/10ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Dec 26, 2019
7. CHARTWELL MOLECULAR
Chartwell Molecular Holdings Llc has filed for 2 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Chartwell Molecular.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
concentrate
Prescription
ORAL
AA
Apr 14, 2014
5MG/5ML
solution
Prescription
ORAL
AA
Jun 24, 2016
8. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Chartwell Rx.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Discontinued
ORAL
N/A
Dec 20, 1985
2MG
tablet
Discontinued
ORAL
N/A
Dec 20, 1985
10MG
tablet
Discontinued
ORAL
N/A
Dec 20, 1985
9. DAVA PHARMS INC
Dava Pharmaceuticals Inc has filed for 2 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Dava Pharms Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Prescription
ORAL
AB
Sep 26, 1985
5MG
tablet
Discontinued
ORAL
N/A
Sep 26, 1985
10. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Dr Reddys.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/2ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Jul 18, 2024
11. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Dr Reddys Labs Sa.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Prescription
ORAL
AB
Feb 3, 1987
2MG
tablet
Prescription
ORAL
AB
Feb 3, 1987
10MG
tablet
Prescription
ORAL
AB
Feb 3, 1987
12. DURAMED PHARMS BARR
Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Duramed Pharms Barr.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Discontinued
ORAL
N/A
Aug 27, 1986
10MG
tablet
Discontinued
ORAL
N/A
Aug 27, 1986
2MG
tablet
Discontinued
ORAL
N/A
Aug 27, 1986
13. ENDO OPERATIONS
Endo Operations Ltd has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Endo Operations.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG
tablet
Discontinued
ORAL
N/A
Sep 26, 1985
2MG
tablet
Discontinued
ORAL
N/A
Sep 26, 1985
5MG
tablet
Discontinued
ORAL
N/A
Sep 26, 1985
14. FERNDALE LABS
Ferndale Laboratories Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Ferndale Labs.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Discontinued
ORAL
N/A
Apr 1, 1987
10MG
tablet
Discontinued
ORAL
N/A
Apr 1, 1987
2MG
tablet
Discontinued
ORAL
N/A
Apr 1, 1987
15. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Fresenius Kabi Usa.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/2ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Nov 10, 2022
Manufacturing Plant Locations
New
Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.
Country
City
Firm Name
United States
Melrose Park
Fresenius Kabi USA LLC
Grand Island
Fresenius Kabi USA, LLC
Melrose Park
Fresenius Kabi USA, LLC
Lake Zurich
Fresenius Kabi USA, LLC
Bensenville
Fresenius Kabi USA LLC (FK USA)
Skokie
Fresenius Kabi USA LLC
North Andover
Fresenius Kabi USA, LLC
Wilson
Fresenius Kabi USA, LLC
16. HALSEY
Halsey Drug Co Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Halsey.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG
tablet
Discontinued
ORAL
N/A
Aug 15, 1986
2MG
tablet
Discontinued
ORAL
N/A
Aug 15, 1986
5MG
tablet
Discontinued
ORAL
N/A
Aug 15, 1986
Manufacturing Plant Locations
New
Halsey's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Halsey as present at those locations.
Country
City
Firm Name
United States
Madison
Halsey Foodservice
17. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Hikma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML (5MG/ML)
injectable
Discontinued
INJECTION
N/A
Dec 16, 1985
10MG/2ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Dec 16, 1985
5MG/ML
injectable
Discontinued
INJECTION
N/A
Jul 17, 1987
50MG/10ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Dec 16, 1985
5MG/5ML
(reference standard)
solution
Prescription
ORAL
AA
Apr 3, 1987
Manufacturing Plant Locations
New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
Country
City
Firm Name
United States
Eatontown
Hikma Pharmaceuticals USA, Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Dayton
Hikma Injectables USA Inc
Portugal
Terrugem Snt
Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman
Hikma Pharmaceuticals LLC
18. HOSPIRA
Hospira Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Hospira.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/10ML (5MG/ML)
(reference standard)
injectable
Prescription
INJECTION
AP
Oct 13, 1987
5MG/ML
injectable
Discontinued
INJECTION
N/A
Oct 13, 1987
10MG/2ML (5MG/ML)
injectable
Prescription
INJECTION
AP
Dec 20, 1988
Manufacturing Plant Locations
New
Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.
Country
City
Firm Name
Australia
Mulgrave
Hospira Australia Pty Ltd.
United States
Pleasant Prairie
Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Clayton
Hospira, Inc.
Morgan Hill
Hospira Inc
Rocky Mount
Hospira, Inc.
Lake Forest
Hospira Inc
Mcpherson
Hospira, Inc., A Pfizer Company
Dominican Republic (the)
Haina, San Cristobal
Hospira, Ltd.
19. IVAX SUB TEVA PHARMS
Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Ivax Sub Teva Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG
tablet
Prescription
ORAL
AB
Dec 10, 1986
5MG
tablet
Prescription
ORAL
AB
Dec 10, 1986
2MG
tablet
Prescription
ORAL
AB
Dec 10, 1986
20. MARSAM PHARMS LLC
Marsam Pharmaceuticals Llc has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Marsam Pharms Llc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
injectable
Discontinued
INJECTION
N/A
Jan 29, 1993
21. MARTEC USA LLC
Martec Usa Llc has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Martec Usa Llc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG
tablet
Discontinued
ORAL
N/A
Apr 25, 1989
22. MYLAN
Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Mylan.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Prescription
ORAL
AB
Sep 4, 1985
10MG
tablet
Prescription
ORAL
AB
Sep 4, 1985
2MG
tablet
Prescription
ORAL
AB
Sep 4, 1985
Manufacturing Plant Locations
New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
Country
City
Firm Name
United States
Saint Albans
Mylan Technologies, Inc.
Santa Barbara
Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos
Mylan Pharmaceuticals Inc.
Rockford
Mylan Institutional, Inc.
Morgantown
Mylan Specialty, L.P.
Morgantown
MYLAN CONSUMER HEALTHCARE Inc.
Greensboro
Mylan Pharmaceuticals Inc
India
Sarigam
Mylan Laboratories Limited
Hyderabad
Mylan Laboratories Limited
Anekal Taluk, Bangalore
Mylan Laboratories Limited
Sinnar
Mylan Laboratories Limited
Aurangabad
Mylan Laboratories Limited (FDF-2)
Hosur
Mylan Laboratories Limited
Bangalore
Mylan Laboratories Limited
Pithampur, District Dhar
Mylan Laboratories Limited
Canada
Etobicoke
Mylan Pharmaceuticals ULC
Ireland
Inverin
Mylan Teoranta
23. NOVEL LABS INC
Novel Laboratories Inc has filed for 2 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Novel Labs Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/2ML (5MG/ML)
gel
Prescription
RECTAL
AB
May 30, 2023
20MG/4ML (5MG/ML)
gel
Prescription
RECTAL
AB
May 30, 2023
24. NUVO PHARM
Nuvo Pharmaceutical Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Nuvo Pharm.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG
tablet
Prescription
ORAL
AB
Feb 25, 1986
5MG
tablet
Prescription
ORAL
AB
Sep 10, 2024
2MG
tablet
Prescription
ORAL
AB
Sep 10, 2024
Manufacturing Plant Locations
New
Nuvo Pharm's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Nuvo Pharm as present at those locations.
Country
City
Firm Name
Canada
Varennes
Nuvo Pharmaceuticals Inc.
25. PARENTA PHARMS
Parenta Pharmaceuticals Inc has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Parenta Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
injectable
Discontinued
INJECTION
N/A
Apr 15, 2004
26. PIONEER PHARMS
Pioneer Pharmaceuticals Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Pioneer Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Discontinued
ORAL
N/A
Aug 2, 1988
10MG
tablet
Discontinued
ORAL
N/A
Aug 2, 1988
5MG
tablet
Discontinued
ORAL
N/A
Aug 2, 1988
27. QUANTUM PHARMICS
Quantum Pharmics Ltd has filed for 3 different strengths of generic version for Diazepam. All of these versions come by the name Q-PAM. Given below are the
details of the strengths of this generic introduced by
Quantum Pharmics.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Discontinued
ORAL
N/A
Apr 29, 1988
2MG
tablet
Discontinued
ORAL
N/A
Apr 29, 1988
10MG
tablet
Discontinued
ORAL
N/A
Apr 29, 1988
28. ROXANE
Roxane Laboratories Inc has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Roxane.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Discontinued
ORAL
N/A
Jun 17, 1986
5MG
tablet
Discontinued
ORAL
N/A
Jun 17, 1986
10MG
tablet
Discontinued
ORAL
N/A
Jun 17, 1986
29. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Strides Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Prescription
ORAL
AB
Mar 31, 2006
10MG
tablet
Prescription
ORAL
AB
Mar 31, 2006
2MG
tablet
Prescription
ORAL
AB
Mar 31, 2006
Manufacturing Plant Locations
New
Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.
Country
City
Firm Name
United States
East Brunswick
Strides Pharma Inc.
Chestnut Ridge
Strides Pharma, Inc.
India
Bangalore
Strides Pharma Science Limited
Puducherry
Strides Pharma Science Limited
30. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Teva Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Discontinued
ORAL
N/A
Nov 1, 1985
31. VIRTUS
Virtus Pharmaceuticals Llc has filed for 2 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Virtus.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Discontinued
ORAL
N/A
Feb 25, 1986
5MG
tablet
Discontinued
ORAL
N/A
Feb 25, 1986
Manufacturing Plant Locations
New
Virtus's manufacturing plants are situated in 2 countries - Chile, United States. Given below are the details of these plant locations as well as the firm names of Virtus as present at those locations.
Country
City
Firm Name
Chile
Linares
Virtus Natura Chile SpA
United States
Bristol
VIRTUS PHARMACEUTICALS, LLC
Nashville
VIRTUS PHARMACEUTICALS OPCO II L
Newtown
VIRTUS PHARMACEUTICALS LLC.
32. WARNER CHILCOTT
Warner Chilcott Div Warner Lambert Co has filed for 4 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Warner Chilcott.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2MG
tablet
Discontinued
ORAL
N/A
Sep 4, 1985
5MG
tablet
Discontinued
ORAL
N/A
Sep 4, 1985
10MG
tablet
Discontinued
ORAL
N/A
Sep 4, 1985
5MG/ML
injectable
Discontinued
INJECTION
N/A
Oct 22, 1987
Manufacturing Plant Locations
New
Warner Chilcott's manufacturing plants are situated in 2 countries - United States, Germany. Given below are the details of these plant locations as well as the firm names of Warner Chilcott as present at those locations.
Country
City
Firm Name
United States
Rockaway
Warner Chilcott US LLC
Manati
Warner Chilcott Company LLC
Norwich
Warner Chilcott Pharmaceuticals, Inc.
Germany
Weiterstadt
Warner Chilcott Deutschland GmbH
33. WATSON LABS
Watson Laboratories Inc has filed for 4 different strengths of generic version for Diazepam. Given below are the
details of the strengths of this generic introduced by
Watson Labs.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG
tablet
Discontinued
ORAL
N/A
Nov 1, 1985
2MG
tablet
Discontinued
ORAL
N/A
Nov 1, 1985
10MG
tablet
Discontinued
ORAL
N/A
Nov 1, 1985
5MG/ML
injectable
Discontinued
INJECTION
N/A
Dec 1, 1986
34. WATSON LABS INC
Watson Laboratories Inc has filed for 1 generic for Diazepam. Given below are the
details of the strengths of this generic introduced by
Watson Labs Inc.
