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Serving leading biopharmaceutical companies globally:

Accenture
Boehringer Ingelheim
UBS
Argus Health
Medtronic
QuintilesIMS
AstraZeneca
Johnson and Johnson
Merck
Chubb

Generated: November 22, 2017

DrugPatentWatch Database Preview

Ketorolac tromethamine; phenylephrine hydrochloride - Generic Drug Details

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What are the generic drug sources for ketorolac tromethamine; phenylephrine hydrochloride and what is the scope of ketorolac tromethamine; phenylephrine hydrochloride patent protection?

Ketorolac tromethamine; phenylephrine hydrochloride
is the generic ingredient in one branded drug marketed by Omeros and is included in one NDA. There are six 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 fifty-one patent family members in thirty countries and eight supplementary protection certificates in eight countries.

There are eighteen drug master file entries for ketorolac tromethamine; phenylephrine hydrochloride. One supplier is listed for this compound.

Summary 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
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ketorolac tromethamine; phenylephrine hydrochloride

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
9,585,895Ophthalmologic irrigation solutions and method► 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; phenylephrine hydrochloride

Country Document Number Estimated Expiration
China101327325► Subscribe
Philippines12015500850► Subscribe
Australia2013201465► Subscribe
Israel238439► Subscribe
Canada2493581► Subscribe
Canada2866848► Subscribe
Australia2009248461► Subscribe
Spain2397574► Subscribe
Japan2006504661► Subscribe
Moldova, Republic of20150050► 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; PHENYLEPHRINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
4 5031-2015Slovakia► SubscribePRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; 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
0150054 00179Estonia► SubscribePRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
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
/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
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
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cipla
Fish and Richardson
Mallinckrodt
Merck
Colorcon
Accenture
US Department of Justice
Baxter
Queensland Health

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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