Glaxosmithkline Company Profile

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GLAXOSMITHKLINE has one hundred and forty-nine approved drugs.

There are thirty-two US patents protecting GLAXOSMITHKLINE drugs.

There are seven hundred and sixteen patent family members on GLAXOSMITHKLINE drugs in fifty-nine countries and one hundred and eighty-eight supplementary protection certificates in twenty countries.

International Patents:	716
US Patents:	32
Tradenames:	104
Ingredients:	90
NDAs:	149
Drug Master File Entries:	8
PTAB Cases with Glaxosmithkline as petitioner:	See PTAB cases with Glaxosmithkline as petitioner

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-001	Feb 1, 2023		DISCN	Yes	No	8,324,208	⤷ Sign Up	Y	Y		⤷ Sign Up
Glaxosmithkline	DARBID	isopropamide iodide	TABLET;ORAL	010744-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-005	Feb 1, 2023		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	ACTIFED W/ CODEINE	codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	012575-003	Apr 4, 1984		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-002	Feb 1, 2023		DISCN	Yes	No	11,649,217	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline	DYCILL	dicloxacillin sodium	CAPSULE;ORAL	060254-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	SEREVENT	salmeterol xinafoate	AEROSOL, METERED;INHALATION	020236-001	Feb 4, 1994	5,126,375*PED	⤷ Sign Up
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	5,126,375*PED	⤷ Sign Up
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	D379506	⤷ Sign Up
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	8,303,986	⤷ Sign Up
Glaxosmithkline	NIX	permethrin	LOTION;TOPICAL	019435-001	Mar 31, 1986	4,024,163	⤷ Sign Up
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982	4,024,271	⤷ Sign Up
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-002	Apr 10, 1987	4,012,444	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	SPC/GB10/012	United Kingdom	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
1740177	C300694	Netherlands	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	CR 2014 00052	Denmark	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
2924034	LUC00114	Luxembourg	⤷ Sign Up	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
1740177	CA 2014 00052	Denmark	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1425001	PA2014019	Lithuania	⤷ Sign Up	PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1740177	C01740177/02	Switzerland	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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