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Generated: June 25, 2017

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Ketorolac tromethamine - Generic Drug Details

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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 twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine has sixty-two patent family members in twenty-three 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:20
Applicants:26
NDAs:46
Drug Master File Entries: see list18
Suppliers / Packagers: see list51
Bulk Api Vendors: see list104
Clinical Trials: see list279
Patent Applications: see list6,956
Therapeutic Class: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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Egalet Us Inc
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 2010RXYesYes6,333,044► SubscribeY ► Subscribe
Luitpold
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION078145-002Jan 14, 2008DISCNNoNo► Subscribe► Subscribe
Gland Pharma Ltd
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION076722-001Jul 27, 2004DISCNNoNo► Subscribe► Subscribe
Hospira
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION074993-001Jan 27, 1999APRXNoNo► Subscribe► Subscribe
Sun Pharma Global
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION078737-002Oct 6, 2008DISCNNoNo► 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 PRESERVATIVE FREE
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC020811-001Nov 3, 19974,454,151*PED► Subscribe
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
Allergan
ACULAR
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 19925,110,493*PED► Subscribe
Roche Palo
TORADOL
ketorolac tromethamine
TABLET;ORAL019645-001Dec 20, 19914,089,969► 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
7,267,827Therapeutic compositions for intranasal administration which include KETOROLAC► Subscribe
7,476,689Therapeutic 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
World Intellectual Property Organization (WIPO)2011028718► Subscribe
Japan2013503873► Subscribe
Australia2009222016► Subscribe
Canada2534484► Subscribe
Spain2382509► 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
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
2015000111Germany► SubscribePRODUCT 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
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
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
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
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Serving 500+ biopharmaceutical companies globally:

Citi
Julphar
Deloitte
Fuji
Colorcon
Teva
Baxter
Harvard Business School
US Army
Cipla

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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