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 Nitroglycerin's patents.
Latest Legal Activities on Nitroglycerin's Patents
Given below is the list recent legal activities going on the following patents of Nitroglycerin.
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Nitroglycerin Generic API Manufacturers
Several generic applications have been filed for Nitroglycerin. The first generic version for Nitroglycerin was by International Medication Systems Ltd and was approved on Sep 10, 1985. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Apr 15, 2025.
Given below is the list of companies who have filed for
Nitroglycerin generic, along with the locations of their manufacturing plants worldwide.
1. ABRAXIS PHARM
Abraxis Pharmaceutical Products has filed for 1 generic for Nitroglycerin. 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
May 8, 1987
2. ACRUX DDS
Acrux Dds Pty Ltd has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Acrux Dds.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4%
ointment
Prescription
INTRA-ANAL
AB
Nov 29, 2024
3. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Actavis Labs Fl Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.6MG
tablet
Discontinued
SUBLINGUAL
N/A
Oct 16, 2017
0.4MG
tablet
Discontinued
SUBLINGUAL
N/A
Oct 16, 2017
0.3MG
tablet
Discontinued
SUBLINGUAL
N/A
Oct 16, 2017
4. AM REGENT
American Regent Inc has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Am Regent.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
(reference standard)
injectable
Prescription
INJECTION
N/A
May 24, 1988
5. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Aurobindo Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.6MG
tablet
Prescription
SUBLINGUAL
AB
Oct 26, 2023
0.3MG
tablet
Prescription
SUBLINGUAL
AB
Oct 26, 2023
0.4MG
tablet
Prescription
SUBLINGUAL
AB
Oct 26, 2023
Manufacturing Plant Locations
New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
Country
City
Firm Name
India
Sangareddy
Aurobindo Pharma Limited
Bachupally
Aurobindo Pharma Limited
Polepally, Mahaboob Nagar
Aurobindo Pharma Limited
Medchal
Aurobindo Pharma Ltd
United States
East Windsor
Aurobindo Pharma USA Inc
6. BAUSCH
Bausch Health Us Llc has filed for 1 generic for Nitroglycerin. This 0.4mg/hr version comes by the name MINITRAN. Given below are the
details of the strengths of this generic introduced by
Bausch.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Aug 30, 1996
Manufacturing Plant Locations
New
Bausch's manufacturing plants are situated in 2 countries - United States, Canada. Given below are the details of these plant locations as well as the firm names of Bausch as present at those locations.
Country
City
Firm Name
United States
Manchester
Bausch & Lomb, Inc.
Bridgewater
Bausch Health Companies, Inc.
Saint Louis
Bausch & Lomb Inc
Rochester
Bausch Health Americas, Inc.
Bridgewater
Bausch and Lomb, Inc
Petaluma
Bausch Health Americas, Inc.
Greenville
Bausch & Lomb Incorporated
Rochester
Bausch & Lomb Incorporated
Irvine
Bausch and Lomb, Incorporated
Wilmington
Bausch & Lomb Incorporated
Rancho Cucamonga
Bausch and Lomb, Incorporated
Woodruff
Bausch & Lomb Inc
Lancaster
Bausch & Lomb Incorporated
Canada
Laval
Bausch Health Companies Inc.
Steinbach
Bausch Health Companies Inc.
7. COSETTE
Cosette Pharmaceuticals Inc has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Cosette.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4%
ointment
Prescription
INTRA-ANAL
AB
Feb 16, 2024
Manufacturing Plant Locations
New
Cosette'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 Cosette as present at those locations.
Country
City
Firm Name
United States
South Plainfield
Cosette Pharmaceuticals, Inc.
Lincolnton
Cosette Pharmaceuticals NC Laboratories, LLC
8. DR REDDYS
Dr Reddys Laboratories Inc has filed for 3 different strengths of generic version for Nitroglycerin. 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
0.4MG
tablet
Prescription
SUBLINGUAL
AB
Aug 26, 2016
0.6MG
tablet
Prescription
SUBLINGUAL
AB
Aug 26, 2016
0.3MG
tablet
Prescription
SUBLINGUAL
AB
Aug 26, 2016
9. ENCUBE
Encube Ethicals Private Ltd has filed for 2 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Encube.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4%
ointment
Prescription
INTRA-ANAL
AB
Dec 16, 2024
2%
ointment
Prescription
TRANSDERMAL
AB
Apr 15, 2025
Manufacturing Plant Locations
New
Encube'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 Encube as present at those locations.
Country
City
Firm Name
India
Ponda
Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai
Encube Ethicals Private Ltd
10. FOUGERA PHARMS INC
Fougera Pharmaceuticals Inc has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Fougera Pharms Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
2%
(reference standard)
ointment
Prescription
TRANSDERMAL
AB
Jul 8, 1988
11. GLENMARK SPECLT
Glenmark Specialty Sa has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Glenmark Speclt.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.3MG
tablet
Prescription
SUBLINGUAL
AB
Sep 19, 2017
0.4MG
tablet
Prescription
SUBLINGUAL
AB
Sep 19, 2017
0.6MG
tablet
Prescription
SUBLINGUAL
AB
Sep 19, 2017
12. HOSPIRA
Hospira Inc has filed for 4 different strengths of generic version for Nitroglycerin. All of these versions come by the name NITROGLYCERIN IN DEXTROSE 5%. Given below are the
details of the strengths of this generic introduced by
Hospira.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
20MG/100ML
injectable
Discontinued
INJECTION
N/A
Aug 31, 1990
10MG/100ML
injectable
Discontinued
INJECTION
N/A
Aug 31, 1990
40MG/100ML
injectable
Discontinued
INJECTION
N/A
Aug 31, 1990
0.1MG/ML
injectable
Discontinued
INJECTION
N/A
Oct 26, 1994
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
Mcpherson
Hospira, Inc., A Pfizer Company
Pleasant Prairie
Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill
Hospira Inc
Clayton
Hospira, Inc.
Lake Forest
Hospira Inc
Rocky Mount
Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal
Hospira, Ltd.
13. INTL MEDICATION
International Medication Systems Ltd has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Intl Medication.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
injectable
Discontinued
INJECTION
N/A
Sep 10, 1985
14. LANNETT CO INC
Lannett Co Inc has filed for 2 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Lannett Co Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Aug 10, 2004
0.2MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Aug 10, 2004
15. LUITPOLD
Luitpold Pharmaceuticals Inc has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Luitpold.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
injectable
Discontinued
INJECTION
N/A
May 24, 1988
16. MANKIND PHARMA
Mankind Pharma Ltd has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Mankind Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4MG
tablet
Prescription
SUBLINGUAL
AB
Dec 5, 2023
0.6MG
tablet
Prescription
SUBLINGUAL
AB
Dec 5, 2023
0.3MG
tablet
Prescription
SUBLINGUAL
AB
Dec 5, 2023
Manufacturing Plant Locations
New
Mankind Pharma'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 Mankind Pharma as present at those locations.
Country
City
Firm Name
India
Imt Manesar
Mankind Pharma Limited
Paonta Sahib
Mankind Pharma Limited
17. MYLAN TECHNOLOGIES
Mylan Technologies Inc has filed for 4 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Mylan Technologies.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.6MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Nov 12, 1999
0.4MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Nov 12, 1999
0.2MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Nov 12, 1999
0.1MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Nov 12, 1999
Manufacturing Plant Locations
New
Mylan Technologies'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 Mylan Technologies as present at those locations.
Country
City
Firm Name
United States
Saint Albans
Mylan Technologies, Inc.
18. NATCO
Natco Pharma Ltd has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Natco.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.6MG
tablet
Prescription
SUBLINGUAL
AB
Apr 30, 2019
0.3MG
tablet
Prescription
SUBLINGUAL
AB
Apr 30, 2019
0.4MG
tablet
Prescription
SUBLINGUAL
AB
Apr 30, 2019
Manufacturing Plant Locations
New
Natco's manufacturing plants are situated in 2 countries - United Kingdom, India. Given below are the details of these plant locations as well as the firm names of Natco as present at those locations.
Country
City
Firm Name
United Kingdom
Hayes
Natco Cash and Carry
Buckingham
Natco Foods Ltd
India
Rangareddy District
Natco Pharma Ltd. - Chemical Division
Hyderabad
NATCO PHARMA LTD
Rangareddy
NATCO Pharma Limited
Chennai
NATCO Pharma Limited Chemical Division Chennai
Hyderabad
Natco Pharma Limited
Paravada
Natco Pharma Limited
19. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Padagis Israel.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4MG/SPRAY
spray, metered
Prescription
SUBLINGUAL
AB
Sep 20, 2013
Manufacturing Plant Locations
New
Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.
Country
City
Firm Name
Israel
Yerucham
Padagis Israel Pharmaceuticals Ltd.
20. PARKE DAVIS
Parke Davis Div Warner Lambert Co has filed for 2 different strengths of generic version for Nitroglycerin. All of these versions come by the name NITROSTAT. Given below are the
details of the strengths of this generic introduced by
Parke Davis.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/ML
injectable
Discontinued
INJECTION
N/A
Jan 8, 1987
5MG/ML
injectable
Discontinued
INJECTION
N/A
Jan 8, 1987
21. RUBICON
Rubicon Research Private Ltd has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Rubicon.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.3MG
tablet
Prescription
SUBLINGUAL
AB
May 3, 2021
0.4MG
tablet
Prescription
SUBLINGUAL
AB
May 3, 2021
0.6MG
tablet
Prescription
SUBLINGUAL
AB
May 3, 2021
Manufacturing Plant Locations
New
Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.
Country
City
Firm Name
United States
Indianapolis
Rubicon Foods LLC
Geismar
Rubicon, LLC
Canada
Concord
Rubicon Research Canada Limited
India
Ambarnath
Rubicon Research Private Limited
22. SANOFI AVENTIS US
Sanofi Aventis Us Llc has filed for 1 generic for Nitroglycerin. This 10mg/ml version comes by the name NITRO-BID. Given below are the
details of the strengths of this generic introduced by
Sanofi Aventis Us.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
10MG/ML
injectable
Discontinued
INJECTION
N/A
Feb 28, 1990
23. SIGMAPHARM LABS LLC
Sigmapharm Laboratories Llc has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Sigmapharm Labs Llc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.3MG
tablet
Discontinued
SUBLINGUAL
N/A
May 7, 2018
0.4MG
tablet
Discontinued
SUBLINGUAL
N/A
May 7, 2018
0.6MG
tablet
Discontinued
SUBLINGUAL
N/A
May 7, 2018
24. SMITH AND NEPHEW
Smith And Nephew Solopak Div Smith And Nephew has filed for 1 generic for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Smith And Nephew.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
5MG/ML
injectable
Discontinued
INJECTION
N/A
Jun 19, 1986
Manufacturing Plant Locations
New
Smith And Nephew'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 Smith And Nephew as present at those locations.
Country
City
Firm Name
United States
Goodlettsville
Smith and Nephew
25. VALEANT PHARMS
Valeant Pharmaceuticals North America Llc has filed for 2 different strengths of generic version for Nitroglycerin. All of these versions come by the name MINITRAN. Given below are the
details of the strengths of this generic introduced by
Valeant Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.6MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Aug 30, 1996
0.1MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Aug 30, 1996
26. VALEANT PHARMS NORTH
Valeant Pharmaceuticals North America Llc has filed for 1 generic for Nitroglycerin. This 0.2mg/hr version comes by the name MINITRAN. Given below are the
details of the strengths of this generic introduced by
Valeant Pharms North.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.2MG/HR
film, extended release
Discontinued
TRANSDERMAL
N/A
Aug 30, 1996
27. VIWIT PHARM
Viwit Pharmaceutical Co Ltd has filed for 3 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Viwit Pharm.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.4MG
tablet
Prescription
SUBLINGUAL
AB
Oct 15, 2024
0.6MG
tablet
Prescription
SUBLINGUAL
AB
Oct 15, 2024
0.3MG
tablet
Prescription
SUBLINGUAL
AB
Oct 15, 2024
Manufacturing Plant Locations
New
Viwit Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Viwit Pharm as present at those locations.
Country
City
Firm Name
China
Tengzhou
Viwit Pharmaceutical Co., Ltd.
28. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 7 different strengths of generic version for Nitroglycerin. Given below are the
details of the strengths of this generic introduced by
Zydus Pharms.
