~ Buy the OMIDRIA (ketorolac tromethamine; phenylephrine hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

OMIDRIA Drug Patent Profile

✉ Email this page to a colleague

« Back to Dashboard

Which patents cover Omidria, and when can generic versions of Omidria launch?

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

This drug has eighty-five patent family members in thirty-nine countries.

The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omidria

A generic version of OMIDRIA was approved as ketorolac tromethamine; phenylephrine hydrochloride by LUPIN LTD on July 1^st, 2019.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for OMIDRIA?
What are the global sales for OMIDRIA?
What is Average Wholesale Price for OMIDRIA?

Summary for OMIDRIA

International Patents:	85
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	5
Drug Prices:	Drug price information for OMIDRIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMIDRIA
What excipients (inactive ingredients) are in OMIDRIA?	OMIDRIA excipients list
DailyMed Link:	OMIDRIA at DailyMed

Drug patent expirations by year for OMIDRIA

Recent Clinical Trials for OMIDRIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Luigi Rondas	Phase 3
European Society of Cataract and Refractive Surgeons	Phase 3
University of Florida	Phase 4

See all OMIDRIA clinical trials

Pharmacology for OMIDRIA

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for OMIDRIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMIDRIA	Injection	ketorolac tromethamine; phenylephrine hydrochloride	1%/0.3%	205388	1	2015-05-29

US Patents and Regulatory Information for OMIDRIA

OMIDRIA is protected by seven US patents.

Patents protecting OMIDRIA

Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OMIDRIA

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	⤷ Sign Up	⤷ Sign Up
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	⤷ Sign Up	⤷ Sign Up
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	⤷ Sign Up	⤷ Sign Up
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OMIDRIA

See the table below for patents covering OMIDRIA around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	104822265	Stable preservative-free mydriatic and anti-inflammatory solutions for injection	⤷ Sign Up
Cyprus	1124481		⤷ Sign Up
Japan	2016196511	安定で保存剤非含有の散瞳および抗炎症注射用液剤 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)	⤷ Sign Up
Lithuania	2911511		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OMIDRIA

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CR 2015 00072	Denmark	⤷ Sign Up	PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	C20150054 00179	Estonia	⤷ Sign Up	PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313	647	Finland	⤷ Sign Up
1534313	1590074-9	Sweden	⤷ Sign Up	PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description