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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 Acular Ls, Sprix, Acuvail, Acular, Acular Preservative Free. 40 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

(Expired)

 Abbvie
Acular Ls US8377982

(Pediatric)

 Ketorolac tromethamine compositions for treating or preventing ocular pain Nov 28, 2024

(Expired)

 Abbvie
Acular Ls US8541463

(Pediatric)

 Ketorolac tromethamine compositions for treating or preventing ocular pain Nov 28, 2024

(Expired)

 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
Critical
 10 Feb, 2017 US7476689
Correspondence Address Change
Critical
 27 Oct, 2010 US7476689
Recordation of Patent Grant Mailed
Critical
 13 Jan, 2009 US7476689
Patent Issue Date Used in PTA Calculation
Critical
 13 Jan, 2009 US7476689
Issue Notification Mailed
Critical
 22 Dec, 2008 US7476689
Dispatch to FDC 15 Dec, 2008 US7476689
Printer Rush- No mailing 05 Dec, 2008 US7476689
Pubs Case Remand to TC
Critical
 13 Nov, 2008 US7476689
Printer Rush- No mailing 05 Nov, 2008 US7476689
Pubs Case Remand to TC
Critical
 29 Sep, 2008 US7476689


Ketorolac Tromethamine's Family Patents

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Ketorolac Tromethamine Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals, Ltd
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited





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


Manufacturing Plant Locations
New

Amphastar Pharm'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 Amphastar Pharm as present at those locations.

Country City Firm Name
United States
Rancho Cucamonga Amphastar Pharmaceuticals, Inc.





3. APOTEX

Apotex 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 Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5%

solution/drops Prescription OPHTHALMIC AT Nov 5, 2009
0.4%

solution/drops Prescription OPHTHALMIC AT Nov 5, 2009


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





4. APOTEX INC

Apotex Inc has filed for 1 generic 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


Manufacturing Plant Locations
New

Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.

Country City Firm Name
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.





5. 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


Manufacturing Plant Locations
New

Apothecon'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 Apothecon as present at those locations.

Country City Firm Name
India
Taluka Padra, Vadodara Apothecon Pharmaceuticals Private Limited





6. 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


Manufacturing Plant Locations
New

Aspiro'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 Aspiro as present at those locations.

Country City Firm Name
India
Siddipet (Dist) Aspiro Pharma Limited





7. 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





8. 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





9. 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


Manufacturing Plant Locations
New

Bedford'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 Bedford as present at those locations.

Country City Firm Name
United States
Curryville Bedford Farm Bureau Cooperative
Shelbyville Bedford Cheese Store Inc
Bedford Bedford Research Foundation, Inc.





10. 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


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





11. 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


Manufacturing Plant Locations
New

Caplin'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 Caplin as present at those locations.

Country City Firm Name
United States
Creve Coeur Caplin, Dr David
India
Gummidipoondi Caplin Steriles Limited





12. 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





13. 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





14. 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


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





15. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Lake Zurich Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Wilson Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
North Andover Fresenius Kabi USA, LLC





16. 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


Manufacturing Plant Locations
New

Gland'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 Gland as present at those locations.

Country City Firm Name
India
Aurangabad Gland Chemical Private Limited
Parawada, Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Sriperumbudur Gland Chemical Private Limited
Hyderabad Gland Pharma Limited
Visakhapatnam Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.





17. 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





18. 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





19. 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


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





20. 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


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Mcpherson Hospira, Inc., A Pfizer Company
Clayton Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Rocky Mount Hospira, Inc.
Morgan Hill Hospira Inc
Lake Forest Hospira Inc
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





21. 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


Manufacturing Plant Locations
New

Leading'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 Leading as present at those locations.

Country City Firm Name
United States
Seattle Leading Edge Jet Center
Fairfield Leading Pharma, LLC





22. 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





23. 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





24. 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


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





25. 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


Manufacturing Plant Locations
New

Nephron'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 Nephron as present at those locations.

Country City Firm Name
United States
Murray Nephron Pharmaceuticals
Mountain Home Nephron Pharmaceuticals
West Columbia Nephron Sterile Compounding Center LLC
West Columbia Nephron Sc Inc





26. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
Croatia
Brdovec Pliva Hrvatska d.o.o.
Zagreb PLIVA Hrvatska d.o.o.
United States
East Hanover Pliva, Inc.
Czech Republic
Brno PLIVA-Lachema a.s.





27. 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





28. 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


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





29. 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





30. STERISCIENCE SPECLTS

Steriscience Specialities 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 Speclts.

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





31. 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 Discontinued OPHTHALMIC N/A Nov 5, 2009


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
India
Bharuch Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd
Ahmednagar Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Punjab Sun Pharmaceutical Industries, Inc.
New Delhi Sun Pharmaceutical Industries Limited
Halol Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Vadodara Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Dadra Sun Pharmaceutical Industries Limited





32. 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


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
Stouffville Teva Canada Limited
Scarborough Teva Canada Limited
Markham Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





33. 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





34. 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


Manufacturing Plant Locations
New

Wockhardt'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 Wockhardt as present at those locations.

Country City Firm Name
India
Solan, Nalagarh Wockhardt Limited - Baddi
Ankleshwar Wockhardt, Ltd.
Aurangabad Wockhardt Limited





35. 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





36. 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


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