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Spil Company Profile

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What is the competitive landscape for SPIL, and when can generic versions of SPIL drugs launch?

SPIL has two approved drugs.

There are two US patents protecting SPIL drugs.

There are six patent family members on SPIL drugs in six countries and five supplementary protection certificates in two countries.

Summary for Spil

International Patents:	6
US Patents:	2
Tradenames:	2
Ingredients:	2
NDAs:	2

Drugs and US Patents for Spil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No	9,504,655		Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-001	Jan 26, 2018		RX	Yes	No	9,504,655		Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-003	Jan 26, 2018		RX	Yes	No	9,700,530		Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-003	Jan 26, 2018		RX	Yes	No	9,504,655		Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No	9,700,530		Y
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-004	Jan 26, 2018		RX	Yes	Yes	9,700,530		Y

International Patents for Spil Drugs

Country	Document Number	Estimated Expiration
Canada	2954474
Mexico	2017000384
World Intellectual Property Organization (WIPO)	2016005934
Japan	2017523164
Australia	2015287299
European Patent Office	3166599

Supplementary Protection Certificates for Spil Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
11/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
12/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
C/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
C/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Similar Applicant Names

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

• Spil