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 Indocin Sr, Tivorbex, Indomethacin. 39 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 31 Aug, 2015 US8992982
Application ready for PDX access by participating foreign offices 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 Hikma Pharmaceuticals Usa Inc and was approved on Nov 19, 2024.

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
25MG

capsule Discontinued ORAL N/A Dec 17, 2003
50MG

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





2. 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





3. 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
50MG

capsule Discontinued ORAL N/A Mar 18, 1987
25MG

capsule Discontinued ORAL N/A Mar 18, 1987





4. 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
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. 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





6. 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





7. 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





8. 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





9. 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





10. 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





11. 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





12. 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





13. 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
East Brunswick Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS





14. 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





15. 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
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





16. 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





17. 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





18. 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





19. 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
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





20. 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





21. 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





22. 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





23. 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
Phoenix Rising Sun Farms Inc
Fort Bragg Rising Tide Sea Vegetables
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





24. 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
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





25. 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





26. 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
25MG

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

capsule Discontinued ORAL N/A Feb 9, 1987





27. 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





28. 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
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





29. 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





30. 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





31. 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
District Solan Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Ankleshwar Zydus Lifesciences Limited





32. 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