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Serving leading biopharmaceutical companies globally:

Fuji
Moodys
Federal Trade Commission
Accenture
Cantor Fitzgerald
Cipla
McKinsey
Dow
Johnson and Johnson
Boehringer Ingelheim

Generated: November 18, 2017

DrugPatentWatch Database Preview

OMIDRIA Drug Profile

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Which patents cover Omidria, and what generic Omidria alternatives are available?

Omidria is a drug marketed by Omeros and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in thirty countries and eight supplementary protection certificates in eight countries.

The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
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► 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
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► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for OMIDRIA

Drugname Dosage Strength RLD Submissiondate
phenylephrine and ketorolacInjection1%/0.3%Omidria5/29/2015

Non-Orange Book Patents for Tradename: OMIDRIA

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 Tradename: OMIDRIA

Country Document Number Estimated Expiration
China104822265► Subscribe
Japan2006504661► Subscribe
Japan2016196511► Subscribe
Japan2013216705► Subscribe
Japan2016014056► Subscribe
Australia2009248461► Subscribe
Canada2493581► Subscribe
Hong Kong1213434► Subscribe
Japan2010132696► Subscribe
Costa Rica20150233► 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: OMIDRIA

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
/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
0150054 00179Estonia► SubscribePRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
AstraZeneca
Baxter
UBS
US Department of Justice
Johnson and Johnson
Novartis
Dow
Julphar

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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