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Glaxosmithkline Llc Company Profile

GLAXOSMITHKLINE LLC has fifteen approved drugs.

There are seven US patents protecting GLAXOSMITHKLINE LLC drugs.

There are one hundred and fifty-one patent family members on GLAXOSMITHKLINE LLC drugs in forty-one countries and fourteen supplementary protection certificates in seven countries.

International Patents:	151
US Patents:	7
Tradenames:	14
Ingredients:	9
NDAs:	15
Drug Master File Entries:	18
Patent Litigation for Glaxosmithkline Llc:	See patent lawsuits for Glaxosmithkline Llc

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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 Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008		DISCN	Yes	No	8,303,986	➤ Sign Up	Y			➤ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-005	Apr 14, 2010	AB	RX	Yes	No	8,637,512	➤ Sign Up	Y			➤ Sign Up
Glaxosmithkline Llc	LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	022251-003	May 8, 2009	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982		DISCN	No	No		➤ Sign Up				➤ Sign Up
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-002	Feb 10, 1998	AB	RX	Yes	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 Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992	4,981,874*PED	➤ Sign Up
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982	4,088,750	➤ Sign Up
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-003	Aug 24, 1998	5,698,226*PED	➤ Sign Up
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-004	Sep 8, 2000	4,602,017*PED	➤ Sign Up
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,335,139	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg	➤ Subscribe	2004-12-22
➤ 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	Orally Disintegrating Tablets	25 mg, 50 mg, 100 mg, and 200 mg	➤ Subscribe	2009-12-21
➤ Subscribe	Tablets	3 mg, 4 mg and 5 mg	➤ Subscribe	2005-02-04
➤ 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

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB02/037	United Kingdom	➤ Sign Up	PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
/1997	Austria	➤ Sign Up	PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310
70035	Netherlands	➤ Sign Up	PRODUCT NAME: NARATRIPTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER NARATRIPTAN-HYDROCHLOR IDE; NAT. REGISTRATION NO/DATE: RVG 21444 19970801; FIRST REGISTRATION: SE 13382 19970310
C0025	Belgium	➤ Sign Up	PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
C0030	France	➤ Sign Up	PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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