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Omeros Company Profile

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What is the competitive landscape for OMEROS, and what generic alternatives to OMEROS drugs are available?

OMEROS has one approved drug.

There are seven US patents protecting OMEROS drugs.

Summary for Omeros

US Patents:	7
Tradenames:	1
Ingredients:	1
NDAs:	1
Patent Litigation for Omeros:	See patent lawsuits for Omeros

Drugs and US Patents for Omeros

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;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes	9,066,856*PED				Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes	9,855,246		Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes	9,278,101*PED				Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014		RX	Yes	Yes	8,586,633*PED				Y

Paragraph IV (Patent) Challenges for OMEROS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	1%/0.3%		2015-05-29

International Patents for Omeros Drugs

Country	Document Number	Estimated Expiration
Canada	2887772
Moldova, Republic of	20150050
Chile	2015001078
Japan	2018009033
South Korea	20170128640
India	3029DEN2015

Supplementary Protection Certificates for Omeros Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0150054 00179	Estonia		PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
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
0784	Netherlands		PRODUCT 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
4 5031-2015	Slovakia		PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730
C0090	France		PRODUCT 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
923	Luxembourg		PRODUCT 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

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Omeros