KETOROLAC TROMETHAMINE Drug Patent Profile
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When do Ketorolac Tromethamine patents expire, and what generic alternatives are available?
Ketorolac Tromethamine is a drug marketed by Alembic, Amphastar Pharm, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz, Steriscience Speclts, Sun Pharm, Wockhardt, Wockhardt Bio Ag, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus Lifesciences, and Lupin Ltd. and is included in fifty-six NDAs.
The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ketorolac Tromethamine
A generic version of KETOROLAC TROMETHAMINE was approved as ketorolac tromethamine; phenylephrine hydrochloride by LUPIN LTD on July 1st, 2019.
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Summary for KETOROLAC TROMETHAMINE
| US Patents: | 0 |
| Applicants: | 36 |
| NDAs: | 56 |
| Finished Product Suppliers / Packagers: | 66 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 108 |
| Patent Applications: | 4,893 |
| Drug Prices: | Drug price information 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 |
| What excipients (inactive ingredients) are in KETOROLAC TROMETHAMINE? | KETOROLAC TROMETHAMINE excipients list |
| DailyMed Link: | KETOROLAC TROMETHAMINE at DailyMed |
See drug prices for KETOROLAC TROMETHAMINE
Recent Clinical Trials for KETOROLAC TROMETHAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Canadian Institutes of Health Research (CIHR) | Phase 3 |
| University of Calgary | Phase 3 |
| University of Miami | Phase 2 |
Pharmacology for KETOROLAC TROMETHAMINE
| Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for KETOROLAC TROMETHAMINE
Anatomical Therapeutic Chemical (ATC) Classes for KETOROLAC TROMETHAMINE
Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SPRIX | Nasal Spray | ketorolac tromethamine | 15.75 mg/spray | 022382 | 1 | 2012-03-12 |
| ACUVAIL | Ophthalmic Solution | ketorolac tromethamine | 0.45% | 022427 | 1 | 2011-08-24 |
| ACULAR LS | Ophthalmic Solution | ketorolac tromethamine | 0.4% | 021528 | 1 | 2005-01-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chartwell Rx | KETOROLAC TROMETHAMINE | ketorolac tromethamine | TABLET;ORAL | 074790-001 | Jun 26, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 074993-002 | Jan 27, 1999 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075222-002 | Apr 26, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Steriscience Speclts | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 078299-001 | Jul 16, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Caplin | KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 218204-001 | Mar 26, 2024 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
