Glycopyrrolate Patent Expiration

Glycopyrrolate is Used for managing chronic obstructive pulmonary disease (COPD) through maintenance treatment of airflow obstruction. It was first introduced by Ah Robins Co in its drug Robinul on Approved Prior to Jan 1, 1982. Other drugs containing Glycopyrrolate are Lonhala Magnair Kit, Robinul Forte, Cuvposa, Dartisla Odt, Glycopyrrolate, Seebri, Glyrx-Pf. 50 different companies have introduced drugs containing Glycopyrrolate.


Glycopyrrolate Patents

Given below is the list of patents protecting Glycopyrrolate, 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
Cuvposa US7638552 Method for increasing the bioavailability of glycopyrrolate Aug 20, 2023

(Expired)

Merz Pharms
Cuvposa US7816396 Method for increasing the bioavailability of glycopyrrolate Aug 20, 2023

(Expired)

Merz Pharms
Lonhala Magnair Kit US10376661 Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element Sep 14, 2035 Sumitomo Pharma Am
Lonhala Magnair Kit US10688518 Method of manufacturing a vibratable head for an aerosol generator and vibratable head for an aerosol generator Nov 12, 2036 Sumitomo Pharma Am
Lonhala Magnair Kit US10744277 Aerosol delivery device and method of operating the aerosol delivery device Dec 07, 2036 Sumitomo Pharma Am
Lonhala Magnair Kit US10940110 Method and system for the treatment of chronic COPD with nebulized anticholinergic administrations Feb 26, 2029 Sumitomo Pharma Am
Lonhala Magnair Kit US11278683 Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Aug 16, 2026 Sumitomo Pharma Am
Lonhala Magnair Kit US6962151 Inhalation nebulizer Oct 27, 2020

(Expired)

Sumitomo Pharma Am
Lonhala Magnair Kit US7316067 Forming a perforate membrane by laser drilling and a subsequent electro-polishing step Sep 06, 2022

(Expired)

Sumitomo Pharma Am
Lonhala Magnair Kit US7458372 Inhalation therapy device Nov 18, 2024 Sumitomo Pharma Am
Lonhala Magnair Kit US7931212 Fluid droplet production apparatus and method Nov 25, 2025 Sumitomo Pharma Am
Lonhala Magnair Kit US8511581 Fluid droplet production apparatus and method Nov 08, 2023

(Expired)

Sumitomo Pharma Am
Lonhala Magnair Kit US9168556 Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer Sep 01, 2032 Sumitomo Pharma Am
Lonhala Magnair Kit US9265900 Disposable ampoule for an aerosol generating device Dec 07, 2028 Sumitomo Pharma Am
Lonhala Magnair Kit US9604018 Aerosol therapy device May 16, 2033 Sumitomo Pharma Am
Lonhala Magnair Kit US9789270 Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Oct 30, 2030 Sumitomo Pharma Am
Robinul US7091236 Method for increasing the bioavailability of glycopyrrolate Apr 24, 2024

(Expired)

Casper Pharma Llc
Robinul Forte US7091236 Method for increasing the bioavailability of glycopyrrolate Apr 24, 2024

(Expired)

Casper Pharma Llc
Seebri US6521260 Carrier particles for use in dry powder inhalers Jan 31, 2016

(Expired)

Novartis
Seebri US6528678 Phosgene-free process for preparing carbamates Apr 24, 2018

(Expired)

Novartis
Seebri US6582678 Carrier particles for use in dry powder inhalers Apr 24, 2018

(Expired)

Novartis
Seebri US7229607 Treatment of respiratory disease Apr 09, 2021

(Expired)

Novartis
Seebri US7736670 Method of making particles for use in a pharmaceutical composition Jun 27, 2021

(Expired)

Novartis
Seebri US8029768 Treatment of respiratory diseases Apr 09, 2021

(Expired)

Novartis
Seebri US8048451 Pharmaceutical compositions for inhalation Jun 27, 2021

(Expired)

Novartis
Seebri US8182838 Dry powder composition comprising co-jet milled particles for pulmonary inhalation Oct 20, 2028 Novartis
Seebri US8303991 Method of making particles for use in a pharmaceutical composition Jun 27, 2021

(Expired)

Novartis
Seebri US8435567 Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation Jun 27, 2021

(Expired)

Novartis
Seebri US8479730 Inhaler device Oct 11, 2028 Novartis
Seebri US8580306 Particles for use in a pharmaceutical composition Jun 27, 2021

(Expired)

Novartis
Seebri US8956661 Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof Jun 27, 2021

(Expired)

Novartis
Seebri US9931304 Method of making particles for use in a pharmaceutical composition Jun 27, 2021

(Expired)

Novartis
Seebri US9962338 Method of making particles for use in a pharmaceutical composition Jun 27, 2021

(Expired)

Novartis


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 Glycopyrrolate's patents.

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

Event Date Patent/Publication
Patent litigations
Maintenance Fee Reminder Mailed 24 Jun, 2024 US8303991(Litigated)
Expire Patent 04 Dec, 2023 US8048451
Maintenance Fee Reminder Mailed 19 Jun, 2023 US8048451
Expire Patent 27 Mar, 2023 US8956661
Payment of Maintenance Fee, 12th Year, Large Entity 22 Mar, 2023 US8029768
Maintenance Fee Reminder Mailed 10 Oct, 2022 US8956661
Expire Patent 18 Jul, 2022 US7736670
Expire Patent 13 Jun, 2022 US9962338
Expire Patent 10 May, 2022 US9931304
Maintenance Fee Reminder Mailed 31 Jan, 2022 US7736670



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Glycopyrrolate Generics

Several generic applications have been filed for Glycopyrrolate. The first generic version for Glycopyrrolate was by Watson Laboratories Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Quagen Pharmaceuticals Llc and was approved on Jul 10, 2024.

Given below is the list of companies who have filed for Glycopyrrolate generic.


1. HERITAGE PHARMS INC

Heritage Pharmaceuticals Inc has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Heritage Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG tablet Prescription ORAL AA Jan 3, 2017
2MG tablet Prescription ORAL AA Jan 3, 2017


2. OXFORD PHARMS

Oxford Pharmaceuticals Llc has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Oxford Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AA Oct 19, 2011
1MG tablet Prescription ORAL AA Oct 19, 2011


3. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Oct 21, 2022


4. NATCO

Natco Pharma Ltd has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Natco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AA Jun 20, 2016
1MG tablet Prescription ORAL AA Jun 20, 2016


5. HIKMA FARMACEUTICA

Hikma Farmaceutica (portugal) Sa has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML

(reference standard)

injectable Prescription INJECTION AP Sep 21, 2011


6. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Jun 23, 2017


7. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Discontinued INJECTION N/A Nov 28, 2018


8. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Glycopyrrolate. 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
1MG tablet Prescription ORAL AA Apr 15, 2013
2MG tablet Prescription ORAL AA Oct 30, 2018


9. APOTEX

Apotex Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Oct 29, 2019


10. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG tablet Prescription ORAL AA Nov 30, 2018
2MG tablet Prescription ORAL AA Nov 30, 2018
0.2MG/ML injectable Prescription INJECTION AP Oct 26, 2022


11. QUAGEN

Quagen Pharmaceuticals Llc has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Quagen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG tablet Prescription ORAL AA Jul 10, 2024
2MG tablet Prescription ORAL AA Jul 10, 2024


12. HIKMA INTL PHARMS

Hikma International Pharmaceuticals Llc has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Hikma Intl Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Discontinued ORAL N/A Mar 5, 2009
1MG tablet Discontinued ORAL N/A Mar 5, 2009


13. SUVEN PHARMS

Suven Pharmaceuticals Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Suven Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/5ML solution Prescription ORAL AA Jul 5, 2022


14. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Sep 30, 2019


15. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Glycopyrrolate. 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
2MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
1MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
0.2MG/ML injectable Discontinued INJECTION N/A Jun 24, 1983


16. LUPIN LTD

Lupin Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Discontinued INJECTION N/A Feb 7, 2023


17. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AA Aug 18, 2009
1MG tablet Prescription ORAL AA Aug 18, 2009


18. LGM PHARMA

Lgm Pharma Solutions Llc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Lgm Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG tablet Prescription ORAL N/A Mar 12, 2012


19. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Jul 6, 2021


20. INDOCO

Indoco Remedies Ltd has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Indoco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AA Feb 3, 2014
1MG tablet Prescription ORAL AA Feb 3, 2014


21. PIRAMAL CRITICAL

Piramal Critical Care Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Piramal Critical.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Oct 25, 2018


22. SAGENT

Sagent Pharmaceuticals has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Sagent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Feb 21, 2020


23. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Glycopyrrolate. 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
0.2MG/ML injectable Discontinued INJECTION N/A Nov 9, 2021


24. TEVA PARENTERAL

Teva Parenteral Medicines Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Teva Parenteral.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Discontinued INJECTION N/A Sep 10, 1991


25. LEADING

Leading Pharma Llc has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Leading.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AA Sep 21, 2012
1MG tablet Prescription ORAL AA Sep 21, 2012


26. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Jul 8, 2020


27. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Glycopyrrolate. 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
1MG tablet Discontinued ORAL N/A Dec 22, 2004
2MG tablet Discontinued ORAL N/A Dec 22, 2004


28. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG tablet Prescription ORAL AA Mar 21, 2008
2MG tablet Prescription ORAL AA Mar 21, 2008


29. XIROMED

Xiromed Pharma Espana Sl has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Mar 4, 2021


30. SANDOZ

Sandoz Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP May 14, 2019


31. AM REGENT

American Regent Inc has filed for 1 generic for Glycopyrrolate. 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
0.2MG/ML injectable Prescription INJECTION AP Jul 23, 1986


32. NIVAGEN PHARMS INC

Nivagen Pharmaceuticals Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Nivagen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Oct 13, 2021


33. ABRAXIS PHARM

Abraxis Pharmaceutical Products has filed for 1 generic for Glycopyrrolate. 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
0.2MG/ML injectable Discontinued INJECTION N/A Jun 12, 1984


34. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Glycopyrrolate. 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
0.2MG/ML injectable Prescription INJECTION AP Oct 31, 2018


35. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Oct 31, 2018


36. CAPLIN

Caplin Steriles Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Caplin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Mar 20, 2019


37. RISING

Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AA Dec 29, 2008
1MG tablet Prescription ORAL AA Dec 29, 2008


38. HOSPIRA

Hospira Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Discontinued INJECTION N/A Jun 15, 1988


39. ENDO OPERATIONS

Endo Operations Ltd has filed for 3 different strengths of generic version for Glycopyrrolate. 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
2MG

(reference standard)

tablet Prescription ORAL AA Aug 31, 2006
1MG

(reference standard)

tablet Prescription ORAL AA Aug 31, 2006
1MG/5ML solution Prescription ORAL AA Aug 9, 2021


40. MANKIND PHARMA

Mankind Pharma Ltd has filed for 1 generic for Glycopyrrolate. 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
0.2MG/ML injectable Discontinued INJECTION N/A Feb 27, 2023


41. ANNORA PHARMA

Annora Pharma Private Ltd has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Annora Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/5ML solution Prescription ORAL AA Jul 5, 2022


42. ASPEN

Aspen Pharma Usa Inc has filed for 1 generic for Glycopyrrolate. Given below are the details of the strengths of this generic introduced by Aspen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG/ML injectable Prescription INJECTION AP Nov 29, 2022