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Serving leading biopharmaceutical companies globally:

Cipla
Deloitte
Baxter
Argus Health
Novartis
Colorcon
Merck
Express Scripts
Moodys
Fish and Richardson

Generated: January 19, 2018

DrugPatentWatch Database Preview

Glaxosmithkline Company Profile

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Summary for Glaxosmithkline
International Patents:1164
US Patents:62
Tradenames:114
Ingredients:96
NDAs:160
Drug Master File Entries: 8

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 BACTOCILL oxacillin sodium FOR SOLUTION;ORAL 062321-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline DYCILL dicloxacillin sodium CAPSULE;ORAL 060254-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline BECONASE beclomethasone dipropionate AEROSOL, METERED;NASAL 018584-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline COMPAZINE prochlorperazine maleate TABLET;ORAL 010571-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-001 Jun 1, 1994 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-001 May 29, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline THORAZINE chlorpromazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 011120-016 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLCOVORIN leucovorin calcium TABLET;ORAL 018342-001 Jul 8, 1983 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Expired US Patents for Glaxosmithkline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ➤ Subscribe ➤ Subscribe
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-002 Jul 26, 1982 ➤ Subscribe ➤ Subscribe
Glaxosmithkline BACTROBAN mupirocin calcium OINTMENT;NASAL 050703-001 Sep 18, 1995 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-002 Dec 27, 1994 ➤ Subscribe ➤ Subscribe
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ➤ Subscribe ➤ Subscribe
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg ➤ Subscribe 2/12/2014
➤ Subscribe Gum 2 mg ➤ Subscribe 1/22/2013
➤ Subscribe Gum 4 mg ➤ Subscribe 1/22/2013
➤ Subscribe Capsule 0.5 mg/0.4 mg ➤ Subscribe 10/26/2010
➤ Subscribe Tablets 62.5 mg/25 mg ➤ Subscribe 9/14/2010
➤ Subscribe Capsules 60 mg ➤ Subscribe 9/8/2010
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 12/21/2009
➤ Subscribe Oral Suspension 750 mg/5 mL ➤ Subscribe 10/20/2009
➤ Subscribe Extended-release Tablets 6 mg ➤ Subscribe 7/22/2009
➤ Subscribe Tablets 250 mg/100 mg ➤ Subscribe 4/3/2009
➤ Subscribe Extended-release Tablets 12 mg ➤ Subscribe 2/5/2009
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 1/8/2009
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 1/8/2009
➤ Subscribe Extended-release Tablets 8 mg ➤ Subscribe 11/3/2008
➤ Subscribe Extended-release Tablets 4 mg ➤ Subscribe 10/31/2008
➤ Subscribe Extended-release Tablets 2 mg ➤ Subscribe 10/14/2008
➤ Subscribe Tablets 100 mg ➤ Subscribe 10/31/2007
➤ Subscribe Tablets 150 mg ➤ Subscribe 10/30/2007
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 10/29/2007
➤ Subscribe Extended-release Capsules 325 mg ➤ Subscribe 11/7/2006
➤ Subscribe Extended-release Capsules 225 mg and 425 mg ➤ Subscribe 10/11/2006
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL (prefilled syringes) ➤ Subscribe 5/9/2006
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2/4/2005
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 12/22/2004
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL vials ➤ Subscribe 10/25/2004

Non-Orange Book US Patents for Glaxosmithkline

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,198,483 Phenethanolamine derivatives for treatment of respiratory diseases ➤ Subscribe
8,647,656 Orally disintegrating tablet compositions of lamotrigine ➤ Subscribe
9,045,469 Muscarinic acetylcholine receptor antagonists ➤ Subscribe
6,032,666 Inhalation device ➤ Subscribe
6,750,210 Formulation containing novel anti-inflammatory androstane derivative ➤ Subscribe
7,498,321 17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents ➤ Subscribe
2,006,107,948 ➤ Subscribe
6,656,453 Medicaments ➤ Subscribe
7,798,368 Fluid dispensing device ➤ Subscribe
7,531,528 Formulation containing anti-inflammatory androstane derivatives ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Glaxosmithkline Drugs

Supplementary Protection Certificates for Glaxosmithkline Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2000 00018 Denmark ➤ Subscribe PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
C0015 France ➤ Subscribe PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
00095 Netherlands ➤ Subscribe PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
C011/2008 Ireland ➤ Subscribe SPC011/2008: 20081105, EXPIRES: 20230110
C0020 Belgium ➤ Subscribe PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
2014 00021 Denmark ➤ Subscribe PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114
C/GB96/040 United Kingdom ➤ Subscribe PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
C/GB99/030 United Kingdom ➤ Subscribe PRODUCT NAME: ZANAMIVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE; REGISTERED: SE 14997 19990209; UK PL10949/0327 19990625
4 50004-2014 Slovakia ➤ Subscribe PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
14/024 Ireland ➤ Subscribe PRODUCT NAME: VILANTEROL OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
QuintilesIMS
Accenture
Queensland Health
Daiichi Sankyo
McKesson
Cerilliant
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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