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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.

There are seventy patent family members on OMEROS drugs in thirty-seven countries and thirteen supplementary protection certificates in twelve countries.

Summary for Omeros

International Patents:	70
US Patents:	7
Tradenames:	1
Ingredients:	1
NDAs:	1

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	AT	RX	Yes	Yes	9,278,101*PED				Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,855,246		Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	8,173,707*PED				Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,486,406*PED				Y
Omeros	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,066,856*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	Patent Number	Estimated Expiration
Costa Rica	20150233
South Korea	101808394
Japan	2015535250
Slovenia	1534313
Japan	2018058905
Australia	2016201834

Supplementary Protection Certificates for Omeros Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	300784	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
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
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
1534313	264 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
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	647	Finland

Similar Applicant Names

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

• Omeros