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Ketorolac tromethamine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ketorolac tromethamine?

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, Egalet Us Inc, Sandoz 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.

This ingredient has sixty patent family members in twenty-three countries.

There are eighteen drug master file entries for ketorolac tromethamine. Fifty-four suppliers are listed for this compound.

Summary for Generic Name: ketorolac tromethamine

Tradenames:8
Patents:20
Applicants:27
NDAs:46
Drug Master File Entries: see list18
Suppliers / Packagers: see list54
Bulk Api Vendors: see list104
Clinical Trials: see list139
Patent Applications: see list4,703
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ketorolac tromethamine at DailyMed

Pharmacology for Ingredient: ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION077943-001Mar 27, 2007DISCNNoNo► Subscribe► Subscribe
Allergan
ACUVAIL
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC022427-001Jul 22, 2009RXYesYes7,842,714► SubscribeYY ► Subscribe
Sandoz
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION076271-001Oct 6, 2004DISCNNoNo► Subscribe► Subscribe
Roche Palo
TORADOL
ketorolac tromethamine
TABLET;ORAL019645-001Dec 20, 1991DISCNYesNo► Subscribe► Subscribe
Gland Pharma Ltd
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION076722-002Jul 27, 2004DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
ACULAR
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 19924,089,969► Subscribe
Allergan
ACULAR LS
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC021528-001May 30, 20035,110,493*PED► Subscribe
Egalet Us Inc
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 20107,476,689► Subscribe
Allergan
ACULAR PRESERVATIVE FREE
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC020811-001Nov 3, 19974,454,151*PED► Subscribe
Allergan
ACULAR
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 19924,454,151*PED► Subscribe
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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► Subscribe
7,267,827Therapeutic 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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International Patent Family for Ingredient: ketorolac tromethamine

Country Document Number Estimated Expiration
BrazilPI0909100► Subscribe
Russian Federation2431469► Subscribe
Japan2013523829► Subscribe
Spain2382509► Subscribe
Denmark2446878► 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 Certificates for Tradename: KETOROLAC TROMETHAMINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00072Denmark► SubscribePRODUCT 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
0784Netherlands► SubscribePRODUCT 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
923Luxembourg► SubscribePRODUCT 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
C0090France► SubscribePRODUCT 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
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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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