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Indomethacin Patent Expiration

Indomethacin is Used for relieving pain. It was first introduced by Zyla Life Sciences Us Llc in its drug Indocin on Approved Prior to Jan 1, 1982. Other drugs containing Indomethacin are Indomethacin, Indocin Sr, Tivorbex. 40 different companies have introduced drugs containing Indomethacin.


Indomethacin Patents

Given below is the list of patents protecting Indomethacin, 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
Tivorbex US8734847 Formulation of indomethacin Apr 23, 2030 Genus
Tivorbex US8992982 Formulation of indomethacin Apr 23, 2030 Genus
Tivorbex US9089471 Formulation of indomethacin Apr 23, 2030 Genus



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 Indomethacin's patents.

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

Activity Date Patent Number
Patent litigations
7.5 yr surcharge - late pmt w/in 6 mo, Small Entity 07 Feb, 2023 US9089471
Payment of Maintenance Fee, 8th Yr, Small Entity 07 Feb, 2023 US9089471
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 06 Feb, 2023 US9089471
Payment of Maintenance Fee, 8th Yr, Small Entity 30 Sep, 2022 US8992982
Payment of Maintenance Fee, 8th Yr, Small Entity 01 Dec, 2021 US8734847
Payment of Maintenance Fee, 4th Year, Large Entity 28 Jan, 2019 US9089471
Payment of Maintenance Fee, 4th Yr, Small Entity 01 Oct, 2018 US8992982
Payment of Maintenance Fee, 4th Yr, Small Entity 27 Nov, 2017 US8734847
Application ready for PDX access by participating foreign offices
Critical
 31 Aug, 2015 US8992982
Application ready for PDX access by participating foreign offices
Critical
 31 Aug, 2015 US9089471


Indomethacin's Family Patents

Family Patents

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Indomethacin Generic API Manufacturers

Several generic applications have been filed for Indomethacin. The first generic version for Indomethacin was by Cycle Pharmaceuticals Ltd and was approved on Jun 18, 1985. And the latest generic version is by Amneal Pharmaceuticals Llc and was approved on Feb 24, 2025.

Given below is the list of companies who have filed for Indomethacin generic, along with the locations of their manufacturing plants worldwide.


1. ABLE

Able Laboratories Inc has filed for 3 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Able.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Discontinued ORAL N/A Feb 6, 2002
50MG

capsule Discontinued ORAL N/A Dec 17, 2003
25MG

capsule Discontinued ORAL N/A Dec 17, 2003


Manufacturing Plant Locations
New

Able's manufacturing plants are situated in 2 countries - United States, Malaysia. Given below are the details of these plant locations as well as the firm names of Able as present at those locations.

Country City Firm Name
United States
Catano Able Sales Company, Inc.
Cincinnati Ablecare Medical Inc
Roseville AbleNet, Inc.
Los Angeles Able Freight Services LLC
Sparks Able Groupe Inc
Raleigh Ablexan Corporation
Mayaguez Able Sales Company
Los Angeles ABLE INC
Malaysia
Telok Panglima Garang Able Dairies





2. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

suppository Prescription RECTAL AB Feb 24, 2025


Manufacturing Plant Locations
New

Amneal'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 Amneal as present at those locations.

Country City Firm Name
United States
Glasgow Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Bridgewater Amneal Complex Products Research LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





3. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Prescription ORAL AB Dec 1, 2010





4. ANI PHARMS

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Mar 18, 1987
50MG

capsule Discontinued ORAL N/A Mar 18, 1987





5. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Indomethacin. 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
75MG

capsule, extended release Discontinued ORAL N/A Dec 27, 2016


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
Medchal Aurobindo Pharma Ltd
Bachupally Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





6. AVANTHI INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Prescription ORAL AB Mar 6, 2009





7. CHARTWELL MOLECULES

Chartwell Molecules Llc has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Chartwell Molecules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Prescription ORAL AB Mar 5, 1986





8. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Indomethacin. 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
75MG

capsule, extended release Prescription ORAL AB Nov 30, 2010





9. COSETTE

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

(reference standard)

suppository Prescription RECTAL AB Aug 31, 1992


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





10. CYCLE

Cycle Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Cycle.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Jun 18, 1985
25MG

capsule Discontinued ORAL N/A Jun 18, 1985





11. DURAMED PHARMS BARR

Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 2 different strengths of generic version for Indomethacin. 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
25MG

capsule Discontinued ORAL N/A Oct 18, 1985
50MG

capsule Discontinued ORAL N/A Oct 18, 1985





12. GLENMARK PHARMS LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB Dec 22, 2010
50MG

(reference standard)

capsule Prescription ORAL AB Dec 22, 2010
75MG

capsule, extended release Prescription ORAL AB Jun 22, 2017





13. HALSEY

Halsey Drug Co Inc has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Halsey.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Jun 3, 1987
25MG

capsule Discontinued ORAL N/A Jun 3, 1987


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





14. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Feb 12, 1986
25MG

capsule Discontinued ORAL N/A Feb 12, 1986


Manufacturing Plant Locations
New

Heritage Pharma'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 Heritage Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS
East Brunswick Heritage Pharmaceuticals Inc





15. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 3 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Prescription ORAL AB Apr 12, 2011
25MG

capsule Prescription ORAL AB Apr 12, 2011
75MG

(reference standard)

capsule, extended release Prescription ORAL AB Sep 28, 2012





16. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/5ML

suspension Discontinued ORAL N/A Mar 18, 1987
50MG

suppository Prescription RECTAL AB Nov 19, 2024


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





17. INWOOD LABS

Inwood Laboratories Inc Sub Forest Laboratories Inc has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Inwood Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Discontinued ORAL N/A Mar 15, 1989





18. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 3 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Jubilant Generics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Discontinued ORAL N/A Oct 5, 2015
25MG

capsule Discontinued ORAL N/A Aug 25, 2017
50MG

capsule Discontinued ORAL N/A Aug 25, 2017


Manufacturing Plant Locations
New

Jubilant Generics'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 Jubilant Generics as present at those locations.

Country City Firm Name
India
Roorkee Jubilant Generics Limited





19. MUTUAL PHARM

Mutual Pharmaceutical Co Inc has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Mutual Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Feb 9, 1987
50MG

capsule Discontinued ORAL N/A Oct 3, 1986





20. MYLAN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Discontinued ORAL N/A Mar 20, 2014


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
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Saint Albans Mylan Technologies, Inc.
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Sinnar Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





21. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Prescription ORAL AB May 8, 2017





22. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/5ML

suspension Prescription ORAL AB Jan 12, 2024


Manufacturing Plant Locations
New

Novitium Pharma'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 Novitium Pharma as present at those locations.

Country City Firm Name
United States
East Windsor Novitium Pharma LLC





23. PIONEER PHARMS

Pioneer Pharmaceuticals Inc has filed for 2 different strengths of generic version for Indomethacin. 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
50MG

capsule Discontinued ORAL N/A Aug 11, 1986
25MG

capsule Discontinued ORAL N/A Aug 11, 1986





24. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Sep 4, 1985


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Fort Bragg Rising Tide Sea Vegetables
Rising Sun Rising Sun Veterinary Clinic
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





25. SANDOZ

Sandoz Inc has filed for 3 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB Apr 29, 1987
50MG

capsule Prescription ORAL AB Apr 29, 1987
75MG

capsule, extended release Discontinued ORAL N/A May 28, 1998


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





26. SUN PHARM INDS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Mar 28, 2013
50MG

capsule Discontinued ORAL N/A Mar 28, 2013





27. SUN PHARM INDUSTRIES

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Feb 9, 1987
25MG

capsule Discontinued ORAL N/A Feb 9, 1987





28. SUPERPHARM

Superpharm Corp has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Superpharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Oct 10, 1986
25MG

capsule Discontinued ORAL N/A Oct 10, 1986





29. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Apr 18, 1988
50MG

capsule Discontinued ORAL N/A Apr 18, 1988


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Fort Dodge TEVA Animal Health Inc
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Markham Teva Canada Limited
Stouffville Teva Canada Limited
Scarborough Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





30. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Indomethacin. 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
25MG

capsule Discontinued ORAL N/A Jul 31, 1991
50MG

capsule Discontinued ORAL N/A Jul 31, 1991





31. WATSON LABS INC

Watson Laboratories Inc has filed for 1 generic for Indomethacin. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

capsule, extended release Discontinued ORAL N/A Dec 9, 2013





32. ZYDUS LIFESCIENCES

Zydus Lifesciences Global Fze has filed for 2 different strengths of generic version for Indomethacin. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB Nov 15, 2010
50MG

suppository Prescription RECTAL AB Aug 2, 2023


Manufacturing Plant Locations
New

Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Jarod Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Matoda Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited





33. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Indomethacin. 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
75MG

capsule, extended release Prescription ORAL AB Sep 25, 2017