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 twenty-five patent family members on GLAXOSMITHKLINE drugs in fifty-nine countries and one hundred and eighty-five supplementary protection certificates in twenty countries.

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

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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	ANCEF	cefazolin sodium	INJECTABLE;INJECTION	050461-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	BACTOCILL	oxacillin sodium	CAPSULE;ORAL	062241-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	EMPRACET W/ CODEINE PHOSPHATE #4	acetaminophen; codeine phosphate	TABLET;ORAL	083951-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-001	Dec 28, 1992		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-002	Feb 1, 2023		RX	Yes	No	11,649,217	⤷ 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

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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	⤷ Try a Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,161,724*PED	⤷ Try a Trial
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999	4,824,860	⤷ Try a Trial
Glaxosmithkline	TRITEC	ranitidine bismuth citrate	TABLET;ORAL	020559-001	Aug 8, 1996	5,601,848	⤷ Try a Trial
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	5,879,706*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Extended-release Tablets	2 mg	➤ Subscribe	2008-10-14

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	13/2008	Austria	⤷ Try a Trial	PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
1633724	C20150012 00136	Estonia	⤷ Try a Trial	PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1425001	SPC/GB14/034	United Kingdom	⤷ Try a Trial	PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
1740177	CR 2014 00052	Denmark	⤷ Try a Trial	PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
2109608	CR 2018 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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