Nitroglycerin Patent Expiration
Nitroglycerin was first introduced by Hospira Inc
Nitroglycerin Patents
Given below is the list of patents protecting Nitroglycerin, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Gonitro | US9101592 | Stabilized granules containing glyceryl trinitrate | Mar 11, 2032 | Pohl Boskamp |
| Nitrolingual Pumpspray | US7872049 | Long-term stable pharmaceutical preparation containing the active ingredient glyceryl trinitrate | Mar 12, 2029 | Pohl Boskamp |
| Nitromist | US5869082 | Buccal, non-polar spray for nitroglycerin |
Apr 16, 2016
(Expired) | Evus |
| Nitrostat | US6500456 | Compressed nitroglycerin tablet and its method of manufacture |
Sep 16, 2018
(Expired) | Viatris |
| Rectiv | US7189761 | Nitric oxide donor composition and method for treatment of anal disorders |
May 27, 2014
(Expired) | Abbvie |
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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 15 Apr, 2019 | US7189761 |
| Maintenance Fee Reminder Mailed | 29 Oct, 2018 | US7189761 |
| Recordation of Patent Grant Mailed | 13 Mar, 2007 | US7189761 |
| Patent Issue Date Used in PTA Calculation | 13 Mar, 2007 | US7189761 |
| Issue Notification Mailed | 21 Feb, 2007 | US7189761 |
| Application Is Considered Ready for Issue | 30 Jan, 2007 | US7189761 |
| Dispatch to FDC | 30 Jan, 2007 | US7189761 |
| Issue Fee Payment Verified | 26 Jan, 2007 | US7189761 |
| Issue Fee Payment Received | 26 Jan, 2007 | US7189761 |
| Mail Notice of Allowance | 30 Oct, 2006 | US7189761 |
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Nitroglycerin Generics
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 Cosette Pharmaceuticals Inc and was approved on Feb 16, 2024.
Given below is the list of companies who have filed for Nitroglycerin generic.
1. 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 |
|---|---|---|---|---|---|
| 0.6MG | tablet | Discontinued | SUBLINGUAL | N/A | May 7, 2018 |
| 0.3MG | tablet | Discontinued | SUBLINGUAL | N/A | May 7, 2018 |
| 0.4MG | tablet | Discontinued | SUBLINGUAL | N/A | May 7, 2018 |
2. 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 |
|---|---|---|---|---|---|
| 0.4MG | tablet | Prescription | SUBLINGUAL | AB | Apr 30, 2019 |
| 0.3MG | tablet | Prescription | SUBLINGUAL | AB | Apr 30, 2019 |
| 0.6MG | tablet | Prescription | SUBLINGUAL | AB | Apr 30, 2019 |
3. 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 |
|---|---|---|---|---|---|
| 0.2MG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 10, 2004 |
| 0.4MG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 10, 2004 |
4. 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 |
5. 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 |
|---|---|---|---|---|---|
| 0.1MG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 30, 1996 |
| 0.6MG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 30, 1996 |
6. 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 |
|---|---|---|---|---|---|
| 0.4MG | tablet | Prescription | SUBLINGUAL | AB | Oct 26, 2023 |
| 0.6MG | tablet | Prescription | SUBLINGUAL | AB | Oct 26, 2023 |
| 0.3MG | tablet | Prescription | SUBLINGUAL | AB | Oct 26, 2023 |
7. 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 |
|---|---|---|---|---|---|
| 5MG/ML | injectable | Discontinued | INJECTION | N/A | Jan 8, 1987 |
| 10MG/ML | injectable | Discontinued | INJECTION | N/A | Jan 8, 1987 |
8. 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 |
9. 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) (reference listed drug) | ointment | Prescription | TRANSDERMAL | N/A | Jul 8, 1988 |
10. 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 |
11. 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 |
12. 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 |
13. 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.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.6MG/HR | film, extended release | Prescription | TRANSDERMAL | AB2 | Oct 30, 1998 |
| 0.2MG/HR | film, extended release | Prescription | TRANSDERMAL | AB2 | Oct 30, 1998 |
| 0.4MG/HR | film, extended release | Prescription | TRANSDERMAL | AB2 | Oct 30, 1998 |
| 0.1MG/HR | film, extended release | Prescription | TRANSDERMAL | AB2 | Oct 30, 2017 |
| 0.6MG | tablet | Discontinued | SUBLINGUAL | N/A | Mar 8, 2022 |
| 0.3MG | tablet | Discontinued | SUBLINGUAL | N/A | Mar 8, 2022 |
| 0.4MG | tablet | Discontinued | SUBLINGUAL | N/A | Mar 8, 2022 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |
18. 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 |
|---|---|---|---|---|---|
| 0.4MG | tablet | Prescription | SUBLINGUAL | AB | May 3, 2021 |
| 0.3MG | tablet | Prescription | SUBLINGUAL | AB | May 3, 2021 |
| 0.6MG | tablet | Prescription | SUBLINGUAL | AB | May 3, 2021 |
19. 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 |
20. 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 |
|---|---|---|---|---|---|
| 0.6MG | tablet | Prescription | SUBLINGUAL | AB | Aug 26, 2016 |
| 0.4MG | tablet | Prescription | SUBLINGUAL | AB | Aug 26, 2016 |
| 0.3MG | tablet | Prescription | SUBLINGUAL | AB | Aug 26, 2016 |
21. 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 |
|---|---|---|---|---|---|
| 10MG/100ML | injectable | Discontinued | INJECTION | N/A | Aug 31, 1990 |
| 40MG/100ML | injectable | Discontinued | INJECTION | N/A | Aug 31, 1990 |
| 20MG/100ML | injectable | Discontinued | INJECTION | N/A | Aug 31, 1990 |
| 0.1MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 26, 1994 |
22. 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 |
23. 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 |
24. 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 |
|---|---|---|---|---|---|
| 0.3MG | tablet | Discontinued | SUBLINGUAL | N/A | Oct 16, 2017 |
| 0.4MG | tablet | Discontinued | SUBLINGUAL | N/A | Oct 16, 2017 |
| 0.6MG | tablet | Discontinued | SUBLINGUAL | N/A | Oct 16, 2017 |
25. 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 |