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	ZOVIRAX	acyclovir sodium	INJECTABLE;INJECTION	018603-002	Jun 29, 1989		DISCN	Yes	No		⤷ Subscribe				⤷ Subscribe
Glaxosmithkline	VONTROL	diphenidol hydrochloride	TABLET;ORAL	016033-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Glaxosmithkline	WELLCOVORIN	leucovorin calcium	TABLET;ORAL	018342-002	Jul 8, 1983		DISCN	Yes	No		⤷ Subscribe				⤷ Subscribe
Glaxosmithkline	THORAZINE	chlorpromazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	011120-016	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
>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	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-001	Apr 10, 1987	4,066,755	⤷ Subscribe
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	RE33994	⤷ Subscribe
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	5,035,237	⤷ Subscribe
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998	4,602,017*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Patent Number	Estimated Expiration
United Kingdom	0313801	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2008109943	⤷ Subscribe
El Salvador	2009003321	⤷ Subscribe
Mexico	PA05009661	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	132013902182575	Italy	⤷ Subscribe	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
0513917	C980018	Netherlands	⤷ Subscribe	PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
2924034	2019/021	Ireland	⤷ Subscribe	PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
0503785	CA 2011 00026	Denmark	⤷ Subscribe	PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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