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	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	11,091,459	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes	RE48285	⤷ Sign Up	Y	Y		⤷ Sign Up
Glaxosmithkline	NALLPEN	nafcillin sodium	INJECTABLE;INJECTION	061999-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	PYOPEN	carbenicillin disodium	INJECTABLE;INJECTION	050298-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>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	018644-003	Dec 30, 1985	4,393,078	⤷ Sign Up
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995	5,578,628*PED	⤷ Sign Up
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	4,425,363	⤷ Sign Up
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	5,290,815	⤷ Sign Up
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994	4,816,263	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	14C0075	France	⤷ Sign Up	PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
1480644	93338	Luxembourg	⤷ Sign Up	PRODUCT NAME: MELANGE OU ASSOCIATION PHARMACEUTIQUE COMPRENANT COMME INGREDIENTS ACTIFS : (1) CEFTAZIDIME OU UN SEL DE CELUI-CI ET (2) AVIBACTAM OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1109 - ZAVICEFTA - CEFTAZIDIME/AVIBACTAM
2240466	122018000052	Germany	⤷ Sign Up	PRODUCT NAME: NIRAPARIBTOSYLAT, EINSCHLIESSLICH NIRAPARIBTOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2506844	300942	Netherlands	⤷ Sign Up	PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2109608	2018016	Norway	⤷ Sign Up	PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.