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Glaxosmithkline Company Profile

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

GLAXOSMITHKLINE has one hundred and eighty-six approved drugs.

There are fifty US patents protecting GLAXOSMITHKLINE drugs.

There are one thousand and seventy-two patent family members on GLAXOSMITHKLINE drugs in fifty-nine countries and one hundred and eighty-five supplementary protection certificates in twenty countries.

Summary for Glaxosmithkline

International Patents:	1072
US Patents:	50
Tradenames:	136
Ingredients:	108
NDAs:	186
Drug Master File Entries:	8
Patent Litigation for Glaxosmithkline:	See patent lawsuits for Glaxosmithkline
PTAB Cases with Glaxosmithkline as petitioner:	See PTAB cases with Glaxosmithkline as petitioner

Drugs and US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	THORAZINE	chlorpromazine hydrochloride	TABLET;ORAL	009149-013	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	THORAZINE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	009149-011	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		RX	Yes	Yes
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994		DISCN	Yes	No
Glaxosmithkline	ADVIL LIQUI-GELS	ibuprofen	CAPSULE;ORAL	020402-001	Apr 20, 1995		OTC	Yes	Yes

Expired US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Cons	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000	5,681,849*PED
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	4,435,449
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996	5,358,970
Glaxosmithkline Cons	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998	4,755,534*PED
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	6,378,519*PED
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	5,879,706*PED

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	62.5 mg/25 mg		2010-09-14
	Extended-release Capsules	325 mg		2006-11-07
	Oral Suspension	750 mg/5 mL		2009-10-20
	Capsules	200 mg/30 mg		2004-12-27
	Extended-release Tablets	4 mg		2008-10-31
	Capsules	0.5 mg		2007-10-29
	Extended-release Tablets	3 mg		2009-01-08
	Tablets	150 mg		2007-10-30
	Extended-release Tablets	2 mg		2008-10-14
	Gum	4 mg		2013-01-22
	Extended-release Tablets	3 mg		2009-01-08
	Injection	6 mg/0.5 mL, 0.5 mL (prefilled syringes)		2006-05-09
	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg		2004-12-22
	Tablets	250 mg/100 mg		2009-04-03
	Capsules	60 mg		2010-09-08
	Extended-release Capsules	225 mg and 425 mg		2006-10-11
	Extended-release Tablets	25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg		2014-02-12
	Capsules	200 mg/38 mg		2016-02-16
	Extended-release Tablets	8 mg		2008-11-03
	Capsule	0.5 mg/0.4 mg		2010-10-26
	Extended-release Tablets	12 mg		2009-02-05
	Gum	2 mg		2013-01-22
	Extended-release Tablets	6 mg		2009-07-22
	Injection	6 mg/0.5 mL, 0.5 mL vials		2004-10-25
	Orally Disintegrating Tablets	25 mg, 50 mg, 100 mg, and 200 mg		2009-12-21
	Tablets	100 mg		2007-10-31
	Tablets	3 mg, 4 mg and 5 mg		2005-02-04

International Patents for Glaxosmithkline Drugs

Country	Patent Number	Estimated Expiration
Australia	2003260336
South Africa	200409592
Spain	2376104
South Africa	200607261
South Korea	101830728
World Intellectual Property Organization (WIPO)	2004011068

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	2018018	Norway		PRODUCT NAME: FARMASOEYTISK; REG. NO/DATE: EU/1/17/1236 20171115
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1305329	SPC011/2008	Ireland		SPC011/2008: 20081105, EXPIRES: 20230110
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2316456	LUC00054	Luxembourg		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2924034	LUC00114	Luxembourg		PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126

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
• Glaxosmithkline Cons
• Glaxosmithkline Llc