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Glaxosmithkline Company Profile

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What is the competitive landscape for GLAXOSMITHKLINE, and when can generic versions of GLAXOSMITHKLINE drugs launch?

GLAXOSMITHKLINE has one hundred and eighty-four approved drugs.

There are forty-six US patents protecting GLAXOSMITHKLINE drugs.

There are nine hundred and seventeen patent family members on GLAXOSMITHKLINE drugs in fifty-seven countries and one hundred and forty-six supplementary protection certificates in nineteen countries.

Summary for Glaxosmithkline

International Patents:	917
US Patents:	46
Tradenames:	134
Ingredients:	106
NDAs:	184
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

Drugs and US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983		DISCN	No	No
Glaxosmithkline	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589-001	Jun 27, 1996		OTC	No	No
Glaxosmithkline	COMPAZINE	prochlorperazine maleate	CAPSULE, EXTENDED RELEASE;ORAL	011000-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005		OTC	Yes	Yes	8,883,849
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-002	Feb 1, 2006	AB	RX	Yes	Yes
Glaxosmithkline	STELAZINE	trifluoperazine hydrochloride	TABLET;ORAL	011552-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes	9,333,310		Y

Expired US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRITEC	ranitidine bismuth citrate	TABLET;ORAL	020559-001	Aug 8, 1996	5,456,925
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	6,004,968*PED
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	5,358,970
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982	4,024,271
Glaxosmithkline	AVODART	dutasteride	CAPSULE;ORAL	021319-001	Nov 20, 2001	5,998,427
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-002	May 14, 1997	5,427,798
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984	4,088,750

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	62.5 mg/25 mg		2010-09-14
	Extended-release Capsules	325 mg		2006-11-07
	Oral Suspension	750 mg/5 mL		2009-10-20
	Capsules	200 mg/30 mg		2004-12-27
	Extended-release Tablets	4 mg		2008-10-31
	Capsules	0.5 mg		2007-10-29
	Extended-release Tablets	3 mg		2009-01-08
	Tablets	150 mg		2007-10-30
	Extended-release Tablets	2 mg		2008-10-14
	Gum	4 mg		2013-01-22
	Extended-release Tablets	3 mg		2009-01-08
	Injection	6 mg/0.5 mL, 0.5 mL (prefilled syringes)		2006-05-09
	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg		2004-12-22
	Tablets	250 mg/100 mg		2009-04-03
	Capsules	60 mg		2010-09-08
	Extended-release Capsules	225 mg and 425 mg		2006-10-11
	Extended-release Tablets	25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg		2014-02-12
	Capsules	200 mg/38 mg		2016-02-16
	Extended-release Tablets	8 mg		2008-11-03
	Capsule	0.5 mg/0.4 mg		2010-10-26
	Extended-release Tablets	12 mg		2009-02-05
	Gum	2 mg		2013-01-22
	Extended-release Tablets	6 mg		2009-07-22
	Injection	6 mg/0.5 mL, 0.5 mL vials		2004-10-25
	Orally Disintegrating Tablets	25 mg, 50 mg, 100 mg, and 200 mg		2009-12-21
	Tablets	100 mg		2007-10-31
	Tablets	3 mg, 4 mg and 5 mg		2005-02-04

International Patents for Glaxosmithkline Drugs

Country	Patent Number	Estimated Expiration
Denmark	1501576
Israel	160595
Spain	2516650
New Zealand	552030
Argentina	032471
Australia	2003254590
Argentina	050902

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299602	97C0036	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
1305329	CA 2008 00022	Denmark
0416951	12/1999	Austria		PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907
0719278	03C0030	France		PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
2506844	C20180017 00244	Estonia		PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
0257344	SPC/GB98/043	United Kingdom		PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Glaxo Grp England
• Glaxo Grp Ltd
• Glaxosmithkline
• Glaxosmithkline Con
• Glaxosmithkline Cons
• Glaxosmithkline Llc