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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Mallinckrodt
Baxter
AstraZeneca
Johnson and Johnson

Last Updated: October 15, 2019

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Glaxosmithkline Llc Company Profile

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Summary for Glaxosmithkline Llc
International Patents:154
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

Drugs and US Patents for Glaxosmithkline Llc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-006 Jun 21, 2011 AB RX Yes No 9,144,547   See Pricing Y   See Pricing
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-006 Dec 27, 1994 DISCN Yes No   See Pricing   See Pricing
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-003 Sep 4, 2003 AB RX Yes Yes   See Pricing   See Pricing
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-006 Apr 10, 2009 AB RX Yes No 8,303,986   See Pricing Y   See Pricing
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994 AB RX Yes No   See Pricing   See Pricing
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-002 Sep 19, 1997 AB RX Yes No   See Pricing   See Pricing
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-001 Aug 24, 1998 AB RX Yes No   See Pricing   See Pricing
>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 Glaxosmithkline Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994 4,602,017*PED   See Pricing
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-001 Jun 1, 1994 4,783,337   See Pricing
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-005 Sep 19, 1997 4,452,808   See Pricing
Glaxosmithkline Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-003 Jul 26, 1982 4,088,750   See Pricing
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 4,452,808   See Pricing
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-001 Jun 1, 1994 4,950,486   See Pricing
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 5,053,432*PED   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Glaxosmithkline Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0303507 97C0102 Belgium   See Pricing PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310
0565634 06C0030 France   See Pricing PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0503785 CA 2011 00026 Denmark   See Pricing PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0480717 98C0025 Belgium   See Pricing PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0303507 C970035 Netherlands   See Pricing 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
0123238 SPC/GB95/004 United Kingdom   See Pricing PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
0454511 SPC/GB99/008 United Kingdom   See Pricing PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Merck
Moodys
McKesson
Mallinckrodt

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