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Ketorolac tromethamine - Generic Drug Details
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This ingredient has fifty-eight patent family members in twenty-two countries.
There are eighteen drug master file entries for ketorolac tromethamine. Fifty-one suppliers are listed for this compound.
Summary for Generic Name: ketorolac tromethamine
| Tradenames: | 8 |
| Patents: | 18 |
| Applicants: | 26 |
| NDAs: | 45 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packaging: see list | 51 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents Ophthalmic Agents |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: ketorolac tromethamine
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Clinical Trials for: ketorolac tromethamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075784-002 | Jan 11, 2002 | RX | No | ||||||||||||||||||||||
Allergan | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | RX | Yes | 8,992,952 | Aug 5, 2024 | Y | |||||||||||||||||||
Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | RX | Yes | 9,216,167 | May 28, 2024 | ||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: ketorolac tromethamine
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Egalet Us Inc | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | 7,476,689 | <disabled> | ||||||||||||||||||||||
Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | 4,089,969 | <disabled> | ||||||||||||||||||||||
Allergan | ACULAR PRESERVATIVE FREE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 020811-001 | Nov 3, 1997 | 4,454,151*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: ketorolac tromethamine
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,476,689 | Therapeutic compositions for intranasal administration which include KETOROLAC | <disabled in preview> | |||||||||||||||||||||||||||
| 7,267,827 | Therapeutic compositions for intranasal administration which include KETOROLAC | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: ketorolac tromethamine
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2717520 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2796071 | <disabled in preview> | |||||||||||||||||||||||||||
| Germany | 69206345 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: KETOROLAC TROMETHAMINE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 923 | Luxembourg | <disabled> | 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 | ||||||||||||||||||||||||||
| 2015 00072 | Denmark | <disabled> | PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 | ||||||||||||||||||||||||||
| 0784 | Netherlands | <disabled> | 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 | ||||||||||||||||||||||||||
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