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Glaxosmithkline Cons Company Profile

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

GLAXOSMITHKLINE CONS has fifteen approved drugs.

There are eleven US patents protecting GLAXOSMITHKLINE CONS drugs.

Summary for Glaxosmithkline Cons

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	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	8,062,264		Y
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	7,541,350		Y
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000		OTC	Yes	Yes

Expired US Patents for Glaxosmithkline Cons

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Cons	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006	6,121,314
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000	4,680,291
Glaxosmithkline Cons	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997	4,755,534*PED

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
7,144,845	Compounds useful in the manufacture of an anti-inflammatory androstane derivative
7,498,321	17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents
6,537,983	Anti-inflammatory androstane derivatives

International Patents for Glaxosmithkline Cons Drugs

Country	Document Number	Estimated Expiration
Slovakia	287576
Israel	177691
Spain	2523930

Supplementary Protection Certificates for Glaxosmithkline Cons Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
6	Finland
C0014	France		PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111

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