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Glaxosmithkline Cons Company Profile

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

GLAXOSMITHKLINE CONS has fifteen approved drugs.

There are eleven US patents protecting GLAXOSMITHKLINE CONS drugs.

There are three hundred and fifteen patent family members on GLAXOSMITHKLINE CONS drugs in forty-eight countries and eighteen supplementary protection certificates in eleven countries.

Summary for Glaxosmithkline Cons

International Patents:	315
US Patents:	11
Tradenames:	11
Ingredients:	10
NDAs:	15

Drugs and US Patents for Glaxosmithkline Cons

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Cons	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997		DISCN	No	No
Glaxosmithkline Cons	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009		OTC	Yes	Yes	8,940,772		Y
Glaxosmithkline Cons	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009		OTC	Yes	Yes	8,501,164		Y
Glaxosmithkline Cons	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002		OTC	Yes	No

Expired US Patents for Glaxosmithkline Cons

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Cons	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997	4,755,534*PED
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	5,681,849*PED
Glaxosmithkline Cons	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	5,681,849*PED
Glaxosmithkline Cons	EXCEDRIN (MIGRAINE)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	5,972,916

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE CONS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	60 mg		2010-09-08
	Gum	4 mg		2013-01-22
	Gum	2 mg		2013-01-22

Non-Orange Book US Patents for Glaxosmithkline Cons

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
7,498,321	17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents
6,777,400	Anti-inflammatory androstane derivative compositions
6,787,532	Formulation containing anti-inflammatory androstane derivatives
7,798,368	Fluid dispensing device

International Patents for Glaxosmithkline Cons Drugs

Country	Document Number	Estimated Expiration
Canada	2603740
Norway	20030549
Germany	60321311
Japan	2008538706

Supplementary Protection Certificates for Glaxosmithkline Cons Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C011/2008	Ireland		SPC011/2008: 20081105, EXPIRES: 20230110
269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
C0042	Belgium		PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729

Similar Applicant Names

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

• Glaxo Grp England
• Glaxo Grp Ltd
• Glaxosmithkline
• Glaxosmithkline Con