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Generated: August 21, 2017
What are the generic drug sources for ketorolac tromethamine and what is the scope of ketorolac tromethamine freedom to operate?
Ketorolac tromethamine is the generic ingredient in eight branded drugs marketed by Allergan, Apotex Inc, Hospira, Amphastar Pharm, Gland Pharma Ltd, Sun Pharma Global, Alcon Pharms Ltd, West-ward Pharms Int, Bedford, Claris, Akorn, Fresenius Kabi Usa, Wockhardt, Luitpold, Roche Palo, Apothecon, Teva, Mylan Labs Ltd, Watson Labs, Mylan, Sagent Pharms, Sandoz Inc, Egalet Us Inc, Pliva, Cycle Pharms Ltd, and Omeros, and is included in forty-six NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 8 |
| Patents: | 19 |
| Applicants: | 26 |
| NDAs: | 46 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packagers: see list | 52 |
| Bulk Api Vendors: see list | 104 |
| Clinical Trials: see list | 283 |
| Patent Applications: see list | 6,972 |
| Therapeutic Class: | Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ketorolac tromethamine at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sagent Pharms | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 091065-001 | Nov 27, 2013 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Apothecon | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075348-001 | Nov 28, 2000 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gland Pharma Ltd | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 204216-001 | Nov 1, 2016 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Claris | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075631-002 | Jun 29, 2001 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Apotex Inc | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075626-001 | Jul 24, 2001 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Egalet Us Inc | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Roche Palo | TORADOL | ketorolac tromethamine | TABLET;ORAL | 019645-001 | Dec 20, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,267,827 | Therapeutic compositions for intranasal administration which include KETOROLAC | ► Subscribe | |||||||||||||||||||||||||||
| 7,476,689 | Therapeutic compositions for intranasal administration which include KETOROLAC | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mexico | 2010009763 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5705552 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 3586735 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2446878 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2011237646 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015000111 | Germany | ► Subscribe | PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728 | ||||||||||||||||||||||||||
| /2015 | Austria | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2015 00072 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C0090 | France | ► Subscribe | PRODUCT NAME: 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; REGISTRATION NO/DATE: EU/1/15/1018 20150728 | ||||||||||||||||||||||||||
| 0784 | Netherlands | ► Subscribe | 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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Serving 500+ 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 verifification 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.
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