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

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

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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 Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	AP1	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-002	Feb 1, 2023		RX	Yes	No	8,815,884	⤷ Try a Trial	Y			⤷ Try a Trial
Glaxosmithkline	THORAZINE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	009149-032	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	WELLCOVORIN	leucovorin calcium	TABLET;ORAL	018342-002	Jul 8, 1983		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	7,488,827	⤷ Try a Trial	Y	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	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014	5,873,360	⤷ Try a Trial
Glaxosmithkline	NIX	permethrin	LOTION;TOPICAL	019435-001	Mar 31, 1986	4,024,163	⤷ Try a Trial
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	5,998,449*PED	⤷ Try a Trial
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985	3,885,046	⤷ Try a Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008	5,422,123	⤷ 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
1425001	174 50004-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
1740177	92565	Luxembourg	⤷ Try a Trial	PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
2109608	667	Finland	⤷ Try a Trial
0656775	28/2000	Austria	⤷ Try a Trial	PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
1110543	SPC/GB08/005	United Kingdom	⤷ Try a Trial	SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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