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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
US Army
Citi
Mallinckrodt
Express Scripts
Argus Health
Accenture
Fish and Richardson
Farmers Insurance

Generated: November 22, 2017

DrugPatentWatch Database Preview

Glaxosmithkline Llc Company Profile

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What is the competitive landscape for GLAXOSMITHKLINE LLC, and what generic alternatives to GLAXOSMITHKLINE LLC drugs are available?

GLAXOSMITHKLINE LLC has fifteen approved drugs.

There are eight 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.

Summary for Glaxosmithkline Llc

International Patents:151
US Patents:8
Tradenames:14
Ingredients:9
NDAs:15
Drug Master File Entries: 16
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;ORAL022008-003Jun 13, 2008ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-005Sep 19, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-001Dec 27, 1994ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-006Dec 27, 1994DISCNYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL ODT
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL022251-001May 8, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Llc
DYAZIDE
hydrochlorothiazide; triamterene
CAPSULE;ORAL016042-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL ODT
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL022251-004May 8, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-002Dec 27, 1994ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
AMERGE
naratriptan hydrochloride
TABLET;ORAL020763-002Feb 10, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Glaxosmithkline Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline Llc
DYNACIRC CR
isradipine
TABLET, EXTENDED RELEASE;ORAL020336-002Jun 1, 1994► Subscribe► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-004Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-001Aug 24, 1998► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-006Apr 10, 2009► Subscribe► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-007Jan 27, 1999► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-005Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
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Paragraph IV activity for GLAXOSMITHKLINE LLC drugs

Drugname Dosage Strength Tradename Submissiondate
lamotrigine
Extended-release Tablets25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg
LAMICTAL XR
2/12/2014
lamotrigine
Orally Disintegrating Tablets25 mg, 50 mg, 100 mg, and 200 mg
LAMICTAL ODT
12/21/2009
atovaquone
Oral Suspension750 mg/5 mL
MEPRON
10/20/2009
ropinirole hydrochloride
Extended-release Tablets6 mg
REQUIP XL
7/22/2009
ropinirole hydrochloride
Extended-release Tablets12 mg
REQUIP XL
2/5/2009
ropinirole hydrochloride*
Extended-release Tablets3 mg
REQUIP XL
1/8/2009
ropinirole hydrochloride
Extended-release Tablets3 mg
REQUIP XL
1/8/2009
ropinirole hydrochloride
Extended-release Tablets8 mg
REQUIP XL
11/3/2008
ropinirole hydrochloride
Extended-release Tablets4 mg
REQUIP XL
10/31/2008
ropinirole hydrochloride
Extended-release Tablets2 mg
REQUIP XL
10/14/2008
propafenone
Extended-release Capsules325 mg
RYTHMOL SR
11/7/2006
propafenone hydrochloride
Extended-release Capsules225 mg and 425 mg
RYTHMOL SR
10/11/2006
ropinirole hydrochloride
Tablets3 mg, 4 mg and 5 mg
REQUIP
2/4/2005
ropinirole hydrochloride
Tablets0.25 mg, 0.5 mg, 1 mg and 2 mg
REQUIP
12/22/2004

Non-Orange Book Patents for Glaxosmithkline Llc

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
8,647,656Orally disintegrating tablet compositions of lamotrigine► Subscribe
8,460,706Hydrophilic/lipophilic polymeric matrix dosage formulation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Glaxosmithkline Llc Drugs

Country Document Number Estimated Expiration
Japan2011057683► Subscribe
Colombia5601025► Subscribe
Austria424827► Subscribe
United Kingdom0203297► Subscribe
Spain2336319► Subscribe
China101411693► Subscribe
Poland202689► Subscribe
South Korea20040084900► Subscribe
Hong Kong1072194► Subscribe
Brazil0313148► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Glaxosmithkline Llc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/004United Kingdom► SubscribePRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
2011 00026Denmark► SubscribePRODUCT 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
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
00095Netherlands► SubscribePRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
C0036Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
C0102Belgium► SubscribePRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
70035Netherlands► SubscribePRODUCT 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
C/GB96/040United Kingdom► SubscribePRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
C/GB02/037United Kingdom► SubscribePRODUCT 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
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Medtronic
Dow
Chinese Patent Office
Cantor Fitzgerald
Merck
UBS
Moodys
Novartis

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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