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Omidria Drug Patent Profile

When do Omidria patents expire, and what generic alternatives are available?

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.

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:	19
Formulation / Manufacturing:	see details
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

See drug prices 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

Anatomical Therapeutic Chemical (ATC) Classes for Omidria

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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			Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes					Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes

Expired US Patents for Omidria

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
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014

International Patents for Omidria

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20170128640	주사용의 안정한 보존제-비함유 산동 및 항-염증 용액 (- - STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLA mMATORY SOLUTIONS FOR INJECTION)
Serbia	62188	STABILNI MIDRIJATSKI I ANTI-INFLAMATORNI RASTVORI BEZ KONZERVANSA ZA UBRIZGAVANJE (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)
Japan	2019081798	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)
South Africa	201502684	STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION

Supplementary Protection Certificates for Omidria

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313	CA 2015 00072	Denmark		PRODUCT 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