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Smithkline Beecham Company Profile

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

SMITHKLINE BEECHAM has six approved drugs.

There are two US patents protecting SMITHKLINE BEECHAM drugs.

There are fifty patent family members on SMITHKLINE BEECHAM drugs in sixteen countries.

Summary for Smithkline Beecham

International Patents:	50
US Patents:	2
Tradenames:	6
Ingredients:	6
NDAs:	6
Drug Master File Entries:	2
Patent Litigation for Smithkline Beecham:	See patent lawsuits for Smithkline Beecham

Drugs and US Patents for Smithkline Beecham

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	Yes	7,268,156*PED				Y
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988		DISCN	No	No
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	AB	RX	Yes	Yes

Expired US Patents for Smithkline Beecham

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	6,022,562*PED
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990	4,466,972
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	4,503,067*PED
Smithkline Beecham	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	5,902,821*PED

Paragraph IV (Patent) Challenges for SMITHKLINE BEECHAM drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Capsules	10 mg and 20 mg		2008-03-18
	Extended-release Capsules	80 mg		2007-11-19
	Capsules	1 g		2008-11-10
	Extended-release Capsules	40 mg		2007-12-21
	Oral Solution	15 mg/mL		2008-05-14

Non-Orange Book US Patents for Smithkline Beecham

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,902,378	Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment
7,626,041	Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment
7,893,100	Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment
7,759,384	Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment

International Patents for Smithkline Beecham Drugs

Country	Document Number	Estimated Expiration
Japan	4718116
World Intellectual Property Organization (WIPO)	2005099671
China	103288714
Brazil	0213175

Similar Applicant Names

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

• Smith And Nephew
• Smithkline Beecham