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Serving leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
Boehringer Ingelheim
Cerilliant
Harvard Business School
McKinsey
McKesson
AstraZeneca
Queensland Health
Mallinckrodt

Generated: December 12, 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 Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Cycle Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Sun Pharma Global, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Alcon Pharms Ltd, Egalet Us Inc, Mylan, Pliva, Teva, Watson Labs, and Omeros, and is included in forty-seven NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine has sixty-nine patent family members in twenty-three countries and six supplementary protection certificates in six countries.

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

Medical Subject Heading (MeSH) Categories for ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AllerganACULAR LSketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC021528-001May 30, 2003ATRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApotheconKETOROLAC TROMETHAMINEketorolac tromethamineINJECTABLE;INJECTION075348-002Nov 28, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
HospiraKETOROLAC TROMETHAMINEketorolac tromethamineINJECTABLE;INJECTION074801-002Jun 5, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
WockhardtKETOROLAC TROMETHAMINEketorolac tromethamineINJECTABLE;INJECTION077942-002Mar 27, 2007APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsKETOROLAC TROMETHAMINEketorolac tromethamineTABLET;ORAL074955-001Sep 19, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AllerganACULAR LSketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC021528-001May 30, 2003ATRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sandoz IncKETOROLAC TROMETHAMINEketorolac tromethamineINJECTABLE;INJECTION076271-001Oct 6, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amphastar PharmKETOROLAC TROMETHAMINEketorolac tromethamineINJECTABLE;INJECTION076209-002Jul 21, 2004APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
OmerosOMIDRIAketorolac tromethamine; phenylephrine hydrochlorideSOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
West-ward Pharms IntKETOROLAC TROMETHAMINEketorolac tromethamineINJECTABLE;INJECTION075772-002Jul 21, 2004DISCNNoNo► Subscribe► Subscribe► 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
AllerganACULAR PRESERVATIVE FREEketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC020811-001Nov 3, 1997► Subscribe► Subscribe
AllerganACULARketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 1992► Subscribe► Subscribe
Egalet Us IncSPRIXketorolac tromethamineSPRAY, METERED;NASAL022382-001May 14, 2010► Subscribe► Subscribe
AllerganACULAR LSketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC021528-001May 30, 2003► Subscribe► Subscribe
AllerganACULARketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 1992► Subscribe► Subscribe
AllerganACULARketorolac tromethamineSOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 1992► Subscribe► Subscribe
Roche PaloTORADOLketorolac tromethamineTABLET;ORAL019645-001Dec 20, 1991► Subscribe► 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
Japan5735968► Subscribe
South Korea20100130989► Subscribe
European Patent Office2257275► Subscribe
Germany69206345► Subscribe
Spain2332049► Subscribe
HungaryE027102► Subscribe
Japan2013503873► Subscribe
Italy1250691► Subscribe
China102497856► Subscribe
Japan2007501799► 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
/2015Austria► SubscribePRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 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
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
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
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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Daiichi Sankyo
US Army
Dow
Moodys
McKesson
Fish and Richardson
Covington
Boehringer Ingelheim

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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