Ketorolac tromethamine; phenylephrine hydrochloride - Generic Drug Details
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What are the generic sources for ketorolac tromethamine; phenylephrine hydrochloride and what is the scope of patent protection?
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 |
Anatomical Therapeutic Chemical (ATC) Classes for ketorolac tromethamine; phenylephrine hydrochloride
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Lupin Ltd | KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 210183-001 | Jul 1, 2019 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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; 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 |
---|---|---|---|
South Korea | 20170128640 | 주사용의 안정한 보존제-비함유 산동 및 항-염증 용액 (- - STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLA mMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
Serbia | 62188 | STABILNI MIDRIJATSKI I ANTI-INFLAMATORNI RASTVORI BEZ KONZERVANSA ZA UBRIZGAVANJE (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
Japan | 2019081798 | 安定で保存剤非含有の散瞳および抗炎症注射用液剤 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
South Africa | 201502684 | STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION | ⤷ Try a Trial |
Japan | 2016196511 | 安定で保存剤非含有の散瞳および抗炎症注射用液剤 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
Japan | 2023041804 | 安定で保存剤非含有の散瞳および抗炎症注射用液剤 | ⤷ Try a Trial |
Eurasian Patent Organization | 033811 | СТАБИЛЬНЫЕ БЕСКОНСЕРВАНТНЫЕ МИДРИАТИЧЕСКИЕ И ПРОТИВОВОСПАЛИТЕЛЬНЫЕ РАСТВОРЫ ДЛЯ ИНЪЕКЦИЙ (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ 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 | 300784 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
1534313 | C 2015 055 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA |
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 | 15C0090 | France | ⤷ Try a Trial | 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 |
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 | C20150054 00179 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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