DrugPatentWatch Database Preview
Ketorolac tromethamine - Generic Drug Details
» See Plans and Pricing
What are the generic sources for ketorolac tromethamine and what is the scope of patent protection?
Ketorolac tromethamine
is the generic ingredient in nine branded drugs marketed by Amphastar Pharm, Apotex Inc, Apothecon, Atlantide, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Nephron, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Micro Labs Ltd India, Zyla, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, Lupin Ltd, and Omeros, and is included in fifty-three NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ketorolac tromethamine has sixty-seven patent family members in twenty-five countries.
There are eighteen drug master file entries for ketorolac tromethamine. Forty-six suppliers are listed for this compound.
Summary for ketorolac tromethamine
International Patents: | 67 |
US Patents: | 19 |
Tradenames: | 9 |
Applicants: | 30 |
NDAs: | 53 |
Drug Master File Entries: | 18 |
Suppliers / Packagers: | 46 |
Bulk Api Vendors: | 78 |
Clinical Trials: | 72 |
Patent Applications: | 6,651 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ketorolac tromethamine |
Drug Sales Revenues: | Drug sales revenues for ketorolac tromethamine |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ketorolac tromethamine |
DailyMed Link: | ketorolac tromethamine at DailyMed |
Recent Clinical Trials for ketorolac tromethamine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 2 |
Oman Medical Speciality Board | Phase 2/Phase 3 |
University of Louisville | Phase 4 |
Pharmacology for ketorolac tromethamine
Drug Class | Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for ketorolac tromethamine
Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
SPRIX | SPRAY, METERED;NASAL | ketorolac tromethamine | 022382 | 2012-03-12 |
ACUVAIL | SOLUTION/DROPS;OPHTHALMIC | ketorolac tromethamine | 022427 | 2011-08-24 |
ACULAR LS | SOLUTION/DROPS;OPHTHALMIC | ketorolac tromethamine | 021528 | 2005-01-28 |
TORADOL | INJECTABLE;INJECTION | ketorolac tromethamine | 019698 | |
TORADOL | TABLET;ORAL | ketorolac tromethamine | 019645 |
US Patents and Regulatory Information for ketorolac tromethamine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 074801-002 | Jun 5, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
West-ward Pharms Int | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075772-002 | Jul 21, 2004 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ketorolac tromethamine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | ACULAR PRESERVATIVE FREE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 020811-001 | Nov 3, 1997 | Start Trial | Start Trial |
Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | Start Trial | Start Trial |
Roche Palo | TORADOL | ketorolac tromethamine | TABLET;ORAL | 019645-001 | Dec 20, 1991 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ketorolac tromethamine
Country | Patent Number | Estimated Expiration |
---|---|---|
Slovenia | 2555770 | Start Trial |
Poland | 1654002 | Start Trial |
South Korea | 20120058588 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ketorolac tromethamine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | 76/2015 | Austria | Start Trial | PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730 |
1534313 | 92923 | Luxembourg | Start Trial | PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730 |
1534313 | 300784 | Netherlands | Start Trial | PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.