Nitroglycerin Patent Expiration

Nitroglycerin was first introduced by Hospira Inc in its drug Tridil on Approved Prior to Jan 1, 1982. Other drugs containing Nitroglycerin are Nitro Iv, Nitrolingual, Nitro-Bid, Transderm-Nitro, Nitromist, Nitrostat, Nitroglycerin, Nitro-Dur, Nitronal, Gonitro, Nitroglycerin In Dextrose 5%, Nitrolingual Pumpspray, Rectiv, Nitrol. 33 different companies have introduced drugs containing Nitroglycerin.


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
Nitrostat US6500456 Compressed nitroglycerin tablet and its method of manufacture Sep 16, 2018

(Expired)

Viatris
Nitromist US5869082 Buccal, non-polar spray for nitroglycerin Apr 16, 2016

(Expired)

Evus
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.

Given below is the list recent legal activities going on the following patents of Nitroglycerin.

Activity Date Patent Number
Patent litigations
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


Nitroglycerin's Family Patents

Family Patents

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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. 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. 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


3. 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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


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. 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


13. 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


14. 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


15. 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


16. 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


17. 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


18. 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


19. 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


20. 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


21. 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


22. 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


23. 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


24. 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


25. 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