GLAXOSMITHKLINE Company Profile

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

GLAXOSMITHKLINE has one hundred and forty-nine approved drugs.

There are thirty-two US patents protecting GLAXOSMITHKLINE drugs.

There are seven hundred and twenty-five 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:	725
US Patents:	32
Tradenames:	104
Ingredients:	90
NDAs:	149
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	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,746,242*PED				Y
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-003	Feb 1, 2023		RX	Yes	No	8,815,884		Y
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990		DISCN	No	No
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987		DISCN	No	No
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-003	May 29, 2009	AB	RX	Yes	No	8,637,512		Y
Glaxosmithkline	TOTACILLIN	ampicillin/ampicillin trihydrate	CAPSULE;ORAL	062212-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for GLAXOSMITHKLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRITEC	ranitidine bismuth citrate	TABLET;ORAL	020559-001	Aug 8, 1996	5,008,256
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,161,724*PED
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999	4,824,860
Glaxosmithkline	TRITEC	ranitidine bismuth citrate	TABLET;ORAL	020559-001	Aug 8, 1996	5,601,848
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	5,879,706*PED
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-002	May 14, 1997	5,731,000
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-003	Mar 27, 1996	4,335,121*PED

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

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

International Patents for GLAXOSMITHKLINE Drugs

Country	Patent Number	Estimated Expiration
Norway	20064006
South Africa	200700851
Spain	2509115
Costa Rica	20160575
Cyprus	1121205
Israel	273282
Norway	2506844

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1425001	C20140013 00103	Estonia		PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
0303507	97C0102	Belgium		PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310
2316456	1790064-8	Sweden		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; REG. NO/DATE: EU/1/14/988 20150330
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217

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 Cons
• Glaxosmithkline Llc