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Ketorolac tromethamine - Generic Drug Details

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Ketorolac tromethamine is the generic ingredient in eight branded drugs marketed by Allergan, Apotex Inc, Hospira, Amphastar Pharm, Sun Pharma Global, Alcon Pharms Ltd, Eurohlth Intl Sarl, Gland Pharma Ltd, Bedford, Claris, Akorn, Fresenius Kabi Usa, Wockhardt, Luitpold, Roche Palo, Apothecon, Teva, Mylan Labs Ltd, Watson Labs, Mylan, Sagent Pharms, Sandoz, Egalet Us Inc, Pliva, Cycle Pharms Ltd, and Omeros, and is included in forty-five NDAs. There are eighteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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 list18
Suppliers / Packaging: see list51
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ketorolac tromethamine

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
Allergan
ACULAR LS
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC021528-001May 30, 2003RXYes8,648,107<disabled>Y <disabled>
Apothecon
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION075348-002Nov 28, 2000DISCNNo<disabled><disabled>
Hospira
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION074993-001Jan 27, 1999RXNo<disabled><disabled>
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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
Allergan
ACULAR
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 19924,089,969<disabled>
Allergan
ACULAR LS
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC021528-001May 30, 20035,110,493*PED<disabled>
Allergan
ACULAR
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 19925,110,493*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
7,476,689Therapeutic compositions for intranasal administration which include KETOROLAC<disabled in preview>
7,267,827Therapeutic 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
China102497856<disabled in preview>
Japan5735968<disabled in preview>
Germany602004023516<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
2015 00072Denmark<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
C0090France<disabled>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
923Luxembourg<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
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