Glaxosmithkline Company Profile

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GLAXOSMITHKLINE has one hundred and forty-nine approved drugs.

There are thirty-one US patents protecting GLAXOSMITHKLINE drugs.

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

International Patents:	702
US Patents:	31
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	TOTACILLIN	ampicillin/ampicillin trihydrate	CAPSULE;ORAL	062212-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-003	Feb 1, 2023		RX	Yes	No	8,815,884	⤷ Try a Trial	Y			⤷ Try a Trial
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-001	May 8, 2009	AB	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	8,309,572	⤷ Try a Trial				⤷ 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	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985	3,885,046	⤷ Try a Trial
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-007	Jan 27, 1999	4,452,808	⤷ Try a Trial
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008	5,422,123	⤷ Try a Trial
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994	5,030,456	⤷ Try a Trial
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	5,126,375*PED	⤷ Try a Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	5,532,246*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	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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	CA 2014 00052	Denmark	⤷ Try a Trial	PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
2506844	C201830030	Spain	⤷ Try a Trial	PRODUCT NAME: UN PRODUCTO FARMACEUTICO QUE COMPRENDE LA COMBINACION DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DE UMECLIDINIO (P.EJ. BROMURO DE UMECLIDINIO), VILANTEROL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (P.EJ. TRIFENATATO DE VILANTEROL) Y FUROATO DE FLUTICASONA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236; DATE OF AUTHORISATION: 20171115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1236; DATE OF FIRST AUTHORISATION IN EEA: 20171115
0565634	06C0030	France	⤷ Try a Trial	PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
1740177	14C0075	France	⤷ Try a Trial	PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
2316456	349 22-2017	Slovakia	⤷ Try a Trial	PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2506844	2018018	Norway	⤷ Try a Trial	PRODUCT NAME: FARMASOEYTISK; REG. NO/DATE: EU/1/17/1236 20171115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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