DrugPatentWatch Database Preview

Glaxosmithkline Company Profile

Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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

GLAXOSMITHKLINE has one hundred and eighty-four approved drugs.

There are forty-six US patents protecting GLAXOSMITHKLINE drugs.

There are nine hundred and fourteen patent family members on GLAXOSMITHKLINE drugs in fifty-seven countries and one hundred and forty-five supplementary protection certificates in nineteen countries.

Summary for Glaxosmithkline

International Patents:	914
US Patents:	46
Tradenames:	134
Ingredients:	106
NDAs:	184
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	8,161,968		Y
Glaxosmithkline	ADVIL MIGRAINE LIQUI-GELS	ibuprofen	CAPSULE;ORAL	020402-002	Mar 16, 2000		OTC	Yes	Yes
Glaxosmithkline Cons	TAVIST-1	clemastine fumarate	TABLET;ORAL	020925-001	Aug 21, 1992		DISCN	Yes	No
Glaxosmithkline	POTIGA	ezogabine	TABLET;ORAL	022345-003	Jun 10, 2011		DISCN	Yes	No
Glaxosmithkline	COMPAZINE	prochlorperazine edisylate	SYRUP;ORAL	011188-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	TICAR	ticarcillin disodium	INJECTABLE;INJECTION	050497-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	BACTOCILL	oxacillin sodium	CAPSULE;ORAL	061336-001	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	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985	4,057,323
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987	4,012,444
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-002	Aug 24, 1998	5,698,226*PED
Glaxosmithkline	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	5,998,427
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997	4,452,808
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-007	Jan 27, 1999	4,452,808
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	6,020,001*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
Canada	2484592
Australia	2003253354
Cyprus	1109422
Cyprus	2578
Germany	60134964
Argentina	040709
Japan	2005523267

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	91429	Luxembourg		91429, EXPIRES: 20230111
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0526543	C990030	Netherlands		PRODUCT NAME: ZANAMIVIRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBARE ESTER; NAT. REGISTRATION NO/DATE: RVG 24094 19990707; FIRST REGISTRATION: 14997 19990209
1740177	14C0075	France		PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
2506844	C20180017 00244	Estonia		PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017

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