Glaxosmithkline Company Profile

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

GLAXOSMITHKLINE has one hundred and forty-nine approved drugs.

There are thirty-two US patents protecting GLAXOSMITHKLINE drugs.

There are seven hundred and twenty-four 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:	724
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

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Glossary

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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	PENTACEF	ceftazidime	INJECTABLE;INJECTION	063322-001	Nov 7, 1995		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,309,572	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	COMPAZINE	prochlorperazine maleate	CAPSULE, EXTENDED RELEASE;ORAL	011000-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	STELAZINE	trifluoperazine hydrochloride	INJECTABLE;INJECTION	011552-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	8,436,185	⤷ Try a Trial		Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Glaxosmithkline

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	5,860,419*PED	⤷ Try a Trial
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996	5,358,970	⤷ Try a Trial
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996	5,763,493	⤷ Try a Trial
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982	4,024,271	⤷ Try a Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	7,927,624	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	5,307,953*PED	⤷ Try a Trial
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996	5,731,000	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

International Patents for Glaxosmithkline Drugs

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Country	Patent Number	Estimated Expiration
Poland	2109608	⤷ Try a Trial
Uruguay	36166	⤷ Try a Trial
European Patent Office	2037922	⤷ Try a Trial
Spain	2548131	⤷ Try a Trial
Norway	20082701	⤷ Try a Trial
Brazil	112020006039	⤷ Try a Trial
Australia	2021204302	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Glaxosmithkline Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2109608	CA 2018 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120
1480644	SPC/GB17/004	United Kingdom	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628
0299602	97C0036	Belgium	⤷ Try a Trial	PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
2506844	LUC00077	Luxembourg	⤷ Try a Trial	PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1425001	CA 2014 00021	Denmark	⤷ Try a Trial	PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
2316456	C201730057	Spain	⤷ Try a Trial	PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2506844	1890025-8	Sweden	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Summary for Glaxosmithkline

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Similar Applicant Names

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