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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-six 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	POTIGA	ezogabine	TABLET;ORAL	022345-003	Jun 10, 2011		DISCN	Yes	No
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-004	Sep 8, 2000	AB	RX	Yes	No
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes	8,746,242		Y
Glaxosmithkline Llc	RYTHMOL	propafenone hydrochloride	TABLET;ORAL	019151-002	Nov 27, 1989		DISCN	Yes	No
Glaxosmithkline	STELAZINE	trifluoperazine hydrochloride	TABLET;ORAL	011552-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Glaxosmithkline	NALLPEN	nafcillin sodium	INJECTABLE;INJECTION	061999-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes	8,201,556		Y

Expired US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	RE39155*PED
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008	5,422,123
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-002	Jul 10, 1986	3,644,353
Glaxosmithkline	BACTROBAN	mupirocin calcium	OINTMENT;NASAL	050703-001	Sep 18, 1995	5,569,672
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,170,717*PED
Glaxosmithkline	AGENERASE	amprenavir	CAPSULE;ORAL	021007-002	Apr 15, 1999	5,585,397
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,131,566*PED

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Glaxosmithkline Drugs

Country	Patent Number	Estimated Expiration
Portugal	1501576
Norway	20050948
Norway	20065417
United Kingdom	0017301
Portugal	1467789
South Korea	101496791
Japan	2011509252

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	93338	Luxembourg		PRODUCT NAME: MELANGE OU ASSOCIATION PHARMACEUTIQUE COMPRENANT COMME INGREDIENTS ACTIFS : (1) CEFTAZIDIME OU UN SEL DE CELUI-CI ET (2) AVIBACTAM OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1109 - ZAVICEFTA - CEFTAZIDIME/AVIBACTAM
2109608	132018000000263	Italy		PRODUCT NAME: NIRAPARIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, UN SUO STEREOISOMERO O TAUTOMERO, IN PARTICOLARE IL TOSILATO O UN IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201

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