Ketorolac tromethamine; phenylephrine hydrochloride - Generic Drug Details
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What are the generic drug sources for ketorolac tromethamine; phenylephrine hydrochloride and what is the scope of freedom to operate?
Ketorolac tromethamine; phenylephrine hydrochloride
is the generic ingredient in two branded drugs marketed by Lupin Ltd and Rayner Surgical, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ketorolac tromethamine; phenylephrine hydrochloride has eighty-five patent family members in thirty-nine countries.
Two suppliers are listed for this compound.
Summary for ketorolac tromethamine; phenylephrine hydrochloride
International Patents: | 85 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ketorolac tromethamine; phenylephrine hydrochloride |
DailyMed Link: | ketorolac tromethamine; phenylephrine hydrochloride at DailyMed |
Pharmacology for ketorolac tromethamine; phenylephrine hydrochloride
Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OMIDRIA | Injection | ketorolac tromethamine; phenylephrine hydrochloride | 1%/0.3% | 205388 | 1 | 2015-05-29 |
US Patents and Regulatory Information for ketorolac tromethamine; phenylephrine hydrochloride
Expired US Patents for ketorolac tromethamine; phenylephrine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ketorolac tromethamine; phenylephrine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1684701 | Ophthalmologic irrigation solutions and method | ⤷ Try a Trial |
Luxembourg | 92923 | ⤷ Try a Trial | |
Costa Rica | 20150233 | SOLUCIONES INYECTABLES ESTABLES EXENTAS DE CONSERVANTES DE COMPUESTOS ANTIMIDRIÁSICOS Y ANTI-INFLAMATORIOS | ⤷ Try a Trial |
New Zealand | 628398 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection | ⤷ Try a Trial |
Japan | 2013216705 | OPHTHALMOLOGIC IRRIGATION SOLUTION AND METHOD | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ketorolac tromethamine; phenylephrine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | CR 2015 00072 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
1534313 | 1590074-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730 |
1534313 | CA 2015 00072 | Denmark | ⤷ Try a Trial | 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 |
1534313 | 264 5031-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
1534313 | 122015000111 | Germany | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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