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-one US patents protecting GLAXOSMITHKLINE drugs.

There are seven hundred and 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:	702
US Patents:	31
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 Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	7,439,393*PED				Y
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-005	Apr 14, 2010	AB	RX	Yes	No	8,637,512		Y
Glaxosmithkline	ZOVIRAX	acyclovir sodium	INJECTABLE;INJECTION	018603-001	Oct 22, 1982		DISCN	Yes	No
Glaxosmithkline	SEREVENT	salmeterol xinafoate	AEROSOL, METERED;INHALATION	020236-001	Feb 4, 1994		DISCN	No	No
Glaxosmithkline	AGENERASE	amprenavir	SOLUTION;ORAL	021039-001	Apr 15, 1999		DISCN	Yes	No

Expired US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982	4,024,271
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	5,028,432*PED
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996	5,731,000
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-002	Feb 10, 1998	4,997,841
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994	4,816,263
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	7,389,775*PED
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	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
	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

International Patents for Glaxosmithkline Drugs

Country	Patent Number	Estimated Expiration
Belgium	2015C024
Japan	4611444
Cyprus	1109422
New Zealand	725966
Russian Federation	2006121459
Japan	2006519827
South Korea	20060066067

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
0526543	SPC/GB99/030	United Kingdom		PRODUCT NAME: ZANAMIVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE; REGISTERED: SE 14997 19990209; UK PL10949/0327 19990625
0257344	SPC/GB98/043	United Kingdom		PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
1425001	174 50004-2014	Slovakia		PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
2240466	18C1020	France		PRODUCT NAME: LE TOSYLATE DE NIRAPARIB OU L'UN DE SES HYDRATES,EN PARTICULIER LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
1425001	1490033-6	Sweden		PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113

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