Ketorolac Tromethamine Patent Expiration

Ketorolac Tromethamine was first introduced by Roche Palo Alto Llc in its drug Toradol on Nov 30, 1989. Other drugs containing Ketorolac Tromethamine are Acuvail, Acular Preservative Free, Sprix, Acular, Acular Ls. 39 different companies have introduced drugs containing Ketorolac Tromethamine.


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
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 US9192571 Ketorolac tromethamine compositions for treating or preventing ocular pain Mar 07, 2028 Abbvie
Acular Ls US8008338

(Pediatric)

Ketorolac tromethamine compositions for treating or preventing ocular pain Nov 24, 2027 Abbvie
Acular Ls US8008338 Ketorolac tromethamine compositions for treating or preventing ocular pain May 24, 2027 Abbvie
Acular Ls US8207215

(Pediatric)

Ketorolac tromethamine compositions for treating or preventing ocular pain Nov 28, 2024 Abbvie
Acular Ls US8377982

(Pediatric)

Ketorolac tromethamine compositions for treating or preventing ocular pain Nov 28, 2024 Abbvie
Acular Ls US8541463

(Pediatric)

Ketorolac tromethamine compositions for treating or preventing ocular pain Nov 28, 2024 Abbvie
Acuvail US8992952 Compositions for delivery of therapeutics into the eyes and methods for making and using same Aug 05, 2024

(Expired)

Abbvie
Acular Ls US8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain May 28, 2024

(Expired)

Abbvie
Acular Ls US8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain May 28, 2024

(Expired)

Abbvie
Acular Ls US8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain May 28, 2024

(Expired)

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
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.

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

Activity Date Patent Number
Patent litigations
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


Ketorolac Tromethamine's Family Patents

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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. 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


2. 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


3. 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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


13. 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


14. 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


15. 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


16. 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


17. 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


18. 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


19. 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


20. 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


21. 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


22. 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


23. 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


24. 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


25. 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


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. 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


28. 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


29. 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


30. 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


31. 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


32. 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


33. 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


34. 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


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