Ketorolac Tromethamine Patent Expiration
Ketorolac Tromethamine was first introduced by Roche Palo Alto Llc
Ketorolac Tromethamine Patents
Given below is the list of patents protecting Ketorolac Tromethamine, 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 |
|---|---|---|---|---|
| Acular Ls | US8008338 | Ketorolac tromethamine compositions for treating or preventing ocular pain | May 24, 2027 | Abbvie |
| Acular Ls |
US8008338 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain | Nov 24, 2027 | Abbvie |
| Acular Ls | US8207215 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls |
US8207215 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain | Nov 28, 2024 | Abbvie |
| Acular Ls | US8377982 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls |
US8377982 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain | Nov 28, 2024 | Abbvie |
| Acular Ls | US8541463 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls |
US8541463 (Pediatric) | Ketorolac tromethamine compositions for treating or preventing ocular pain | Nov 28, 2024 | Abbvie |
| Acular Ls | US8648107 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls | US8906950 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls | US8946281 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls | US9216127 | Burial vault and method for customizing a burial vault |
May 28, 2024
(Expired) | Abbvie |
| Acular Ls | US9216167 | Ketorolac tromethamine compositions for treating or preventing ocular pain |
May 28, 2024
(Expired) | Abbvie |
| Acuvail | US7842714 | Ketorolac tromethamine compositions for treating ocular pain | Aug 15, 2029 | Abbvie |
| Acuvail | US8512717 | Compositions for delivery of therapeutics into the eyes and methods for making and using same | Mar 07, 2028 | Abbvie |
| Acuvail | US8992952 | Compositions for delivery of therapeutics into the eyes and methods for making and using same | Aug 05, 2024 | Abbvie |
| Acuvail | US9192571 | Ketorolac tromethamine compositions for treating or preventing ocular pain | Mar 07, 2028 | Abbvie |
| Sprix | US6333044 | Therapeutic compositions for intranasal administration which include KETOROLAC® |
Dec 25, 2018
(Expired) | Zyla |
| Sprix | US7476689 | Therapeutic compositions for intranasal administration which include KETOROLAC |
Oct 11, 2012
(Expired) | Zyla |
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 Ketorolac Tromethamine's patents.
Latest Legal Activities on Ketorolac Tromethamine's Patents
Given below is the list recent legal activities going on the following patents of Ketorolac Tromethamine.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 10 Feb, 2017 | US7476689 |
| Correspondence Address Change | 27 Oct, 2010 | US7476689 |
| Recordation of Patent Grant Mailed | 13 Jan, 2009 | US7476689 |
| Patent Issue Date Used in PTA Calculation | 13 Jan, 2009 | US7476689 |
| Issue Notification Mailed | 22 Dec, 2008 | US7476689 |
| Dispatch to FDC | 15 Dec, 2008 | US7476689 |
| Printer Rush- No mailing | 05 Dec, 2008 | US7476689 |
| Pubs Case Remand to TC | 13 Nov, 2008 | US7476689 |
| Printer Rush- No mailing | 05 Nov, 2008 | US7476689 |
| Pubs Case Remand to TC | 29 Sep, 2008 | US7476689 |
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Ketorolac Tromethamine Generics
Several generic applications have been filed for Ketorolac Tromethamine. The first generic version for Ketorolac Tromethamine was by Teva Pharmaceuticals Usa Inc and was approved on May 16, 1997. And the latest generic version is by Caplin Steriles Ltd and was approved on Mar 26, 2024.
Given below is the list of companies who have filed for Ketorolac Tromethamine generic.
1. ASPIRO
Aspiro Pharma Ltd has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Aspiro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Prescription | INJECTION | AP | Jun 20, 2023 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Jun 20, 2023 |
2. APOTEX INC
Apotex Inc Richmond Hill has filed for 3 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Apotex Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 14, 2005 |
| 0.5% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 5, 2009 |
| 0.4% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 5, 2009 |
3. TEVA
Teva Pharmaceuticals Usa Inc has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG
(reference standard) | tablet | Prescription | ORAL | AB | May 16, 1997 |
4. STERISCIENCE
Steriscience Pte Ltd has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Steriscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Aug 4, 2014 |
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Aug 4, 2014 |
5. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 1 generic for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Aug 25, 2022 |
6. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 0.4% | solution/drops | Discontinued | OPHTHALMIC | N/A | Nov 15, 2018 |
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 20, 2020 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 20, 2020 |
| 0.5% | solution/drops | Discontinued | OPHTHALMIC | N/A | Dec 3, 2020 |
7. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Prescription | INJECTION | AP | Nov 2, 2022 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Nov 2, 2022 |
8. MICRO LABS LTD INDIA
Micro Labs Ltd India has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Micro Labs Ltd India.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5% | solution/drops | Prescription | OPHTHALMIC | AT | Apr 5, 2019 |
9. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable | Discontinued | INJECTION | N/A | Apr 26, 1999 |
| 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable | Discontinued | INJECTION | N/A | Apr 26, 1999 |
| 15MG/ML | injectable | Prescription | INJECTION | AP | Jul 21, 2004 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Jul 21, 2004 |
10. WATSON LABS
Watson Laboratories Inc has filed for 1 generic for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 10MG | tablet | Discontinued | ORAL | N/A | Sep 19, 1997 |
11. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 2 different strengths of generic version for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Jul 27, 2004 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Jul 27, 2004 |
12. PLIVA
Pliva Inc has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Pliva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Discontinued | ORAL | N/A | Jun 23, 1999 |
13. SENORES PHARMS
Senores Pharmaceuticals Inc has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Senores Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Mar 23, 2022 |
14. WOCKHARDT
Wockhardt Ltd has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Wockhardt.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Prescription | INJECTION | AP | Mar 27, 2007 |
| 15MG/ML | injectable | Prescription | INJECTION | AP | Mar 27, 2007 |
15. LEADING
Leading Pharma Llc has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Leading.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Feb 23, 2023 |
16. BIONPHARMA
Bionpharma Inc has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Bionpharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Feb 23, 2023 |
17. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Aug 16, 2018 |
| 0.5% | solution/drops | Discontinued | OPHTHALMIC | N/A | Nov 5, 2009 |
18. SANDOZ
Sandoz Inc has filed for 4 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Prescription | INJECTION | AP | Oct 6, 2004 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 6, 2004 |
| 0.4% | solution/drops | Discontinued | OPHTHALMIC | N/A | Nov 5, 2009 |
| 0.5% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 5, 2009 |
19. WOCKHARDT BIO AG
Wockhardt Bio Ag has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Wockhardt Bio Ag.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Mar 27, 2007 |
20. LUITPOLD
Luitpold Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Luitpold.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Jan 14, 2008 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Jan 14, 2008 |
21. BEDFORD
Bedford Laboratories Div Ben Venue Laboratories Inc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Bedford.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 25, 1999 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 25, 1999 |
22. NEPHRON
Nephron Pharmaceuticals Corporation has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Nephron.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Prescription | INJECTION | AP | Aug 20, 2020 |
23. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Prescription | INJECTION | AP | Oct 7, 2015 |
| 15MG/ML | injectable | Prescription | INJECTION | AP | Oct 7, 2015 |
24. GLAND
Gland Pharma Ltd has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Gland.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Prescription | INJECTION | AP | Nov 1, 2016 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Nov 1, 2016 |
25. CAPLIN
Caplin Steriles Ltd has filed for 3 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Caplin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Prescription | INJECTION | AP | May 10, 2023 |
| 15MG/ML | injectable | Prescription | INJECTION | AP | May 10, 2023 |
| 0.5% | solution/drops | Prescription | OPHTHALMIC | AT | Mar 26, 2024 |
26. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Prescription | INJECTION | AP | Nov 27, 2013 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Nov 27, 2013 |
27. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | May 16, 1997 |
28. ATNAHS PHARMA US
Atnahs Pharma Us Ltd has filed for 1 generic for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Atnahs Pharma Us.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Oct 21, 2022 |
29. AMPHASTAR PHARM
Amphastar Pharmaceutical Inc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Amphastar Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Jul 21, 2004 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Jul 21, 2004 |
30. HOSPIRA
Hospira Inc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Hospira.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Jan 27, 1999 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Jan 27, 1999 |
31. BAXTER HLTHCARE CORP
Baxter Healthcare Corp has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Prescription | INJECTION | AP | Sep 15, 2017 |
| 15MG/ML | injectable | Prescription | INJECTION | AP | Jul 25, 2018 |
32. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/ML | injectable | Prescription | INJECTION | AP | Oct 6, 2008 |
| 30MG/ML | injectable | Prescription | INJECTION | AP | Oct 6, 2008 |
| 0.5% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 5, 2009 |
33. EPIC PHARMA LLC
Epic Pharma Llc has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.4% | solution/drops | Discontinued | OPHTHALMIC | N/A | Nov 5, 2009 |
| 0.45% | solution/drops | Discontinued | OPHTHALMIC | N/A | Feb 10, 2014 |
34. APOTHECON
Apothecon Inc Div Bristol Myers Squibb has filed for 2 different strengths of generic version for Ketorolac Tromethamine. Given below are the details of the strengths of this generic introduced by Apothecon.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/ML | injectable | Discontinued | INJECTION | N/A | Nov 28, 2000 |
| 15MG/ML | injectable | Discontinued | INJECTION | N/A | Nov 28, 2000 |
35. ZYDUS LIFESCIENCES
Zydus Lifesciences Global Fze has filed for 1 generic for Ketorolac Tromethamine. 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 |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Oct 21, 2022 |