Indomethacin Patent Expiration
Indomethacin is Used for relieving pain. It was first introduced by Zyla Life Sciences Us Llc
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.
Latest Legal Activities on Indomethacin's Patents
Given below is the list recent legal activities going on the following patents of Indomethacin.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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Indomethacin Generics
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 Novitium Pharma Llc and was approved on Jan 12, 2024.
Given below is the list of companies who have filed for Indomethacin generic.
1. 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 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
10. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic 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 |
11. 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 |
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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |
18. 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 |
19. 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 |
20. 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 |
21. 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 |
22. 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 |
23. 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 |
24. 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 |
25. 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 |
26. RISING
Rising Pharma Holding 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 Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | capsule | Discontinued | ORAL | N/A | Sep 4, 1985 |
| 75MG | capsule, extended release | Discontinued | ORAL | N/A | Mar 20, 2014 |
27. 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 |
28. 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 |
29. 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 |
30. 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 |
31. 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 |