Glaxo Company Profile

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

GLAXO has one hundred and fifty-eight approved drugs.

There are thirty-six US patents protecting GLAXO drugs.

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

Summary for Glaxo

International Patents:	757
US Patents:	36
Tradenames:	116
Ingredients:	93
NDAs:	158
Drug Master File Entries:	1
Patent Litigation for Glaxo:	See patent lawsuits for Glaxo
PTAB Cases with Glaxo as petitioner:	See PTAB cases with Glaxo as petitioner

Drugs and US Patents for Glaxo

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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	JESDUVROQ	daprodustat	TABLET;ORAL	216951-004	Feb 1, 2023		RX	Yes	No	11,643,397	⤷ 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	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	11,730,725	⤷ Try a Trial	Y			⤷ Try a Trial
Glaxosmithkline	MONOCID	cefonicid sodium	INJECTABLE;INJECTION	063295-001	Jul 26, 1993		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006		RX	Yes	Yes	7,500,444*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	8,746,242*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Glaxosmithkline	THORAZINE	chlorpromazine hydrochloride	TABLET;ORAL	009149-020	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ 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

Expired US Patents for Glaxo

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	5,225,445*PED	⤷ Try a Trial
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	4,128,658	⤷ Try a Trial
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983	4,521,431*PED	⤷ Try a Trial
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000	6,032,666*PED	⤷ Try a Trial
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-003	May 14, 1997	5,358,970	⤷ Try a Trial
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	6,536,427*PED	⤷ 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

Paragraph IV (Patent) Challenges for GLAXO drugs

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

International Patents for Glaxo Drugs

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Country	Patent Number	Estimated Expiration
Spain	2435397	⤷ Try a Trial
China	1829547	⤷ Try a Trial
Luxembourg	92680	⤷ Try a Trial
Denmark	1960021	⤷ Try a Trial
Poland	1649017	⤷ Try a Trial
Taiwan	I394747	⤷ Try a Trial
United Kingdom	0214360	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Glaxo Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	18C1020	France	⤷ Try a Trial	PRODUCT NAME: LE TOSYLATE DE NIRAPARIB OU L'UN DE SES HYDRATES,EN PARTICULIER LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
0526543	34/1999	Austria	⤷ Try a Trial	PRODUCT NAME: ''ZANAMIVIR'' GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS; NAT. REGISTRATION NO/DATE: 1-23120 19990702; FIRST REGISTRATION: SE 14997 19990209
1425001	C01425001/02	Switzerland	⤷ Try a Trial	PRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1425001	C 2014 016	Romania	⤷ Try a Trial	PRODUCT NAME: VILANTEROL SAU O SARE SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF NATIONAL AUTHORISATION: 20131113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF FIRST AUTHORISATION IN EEA: 20131113
2506844	394 50009-2018	Slovakia	⤷ Try a Trial	PRODUCT NAME: FLUTIKAZONFUROAT / UMEKLIDINIUM / VILANTEROL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1236/001 - EU/1/17/1236/003 20171117
2240466	C201830027	Spain	⤷ Try a Trial	PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
1425001	PA2014019,C1425001	Lithuania	⤷ Try a Trial	PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
>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 Glaxo

Paragraph IV (Patent) Challenges for GLAXO drugs

Similar Applicant Names

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