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Serving 500+ biopharmaceutical companies globally:

Deloitte
UBS
Federal Trade Commission
McKinsey
Julphar
Cipla
Covington
Harvard Business School
Daiichi Sankyo
Cerilliant

Generated: September 20, 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-two patent family members on GLAXOSMITHKLINE LLC drugs in forty-one countries.

Summary for Applicant: Glaxosmithkline Llc

Patents:8
Tradenames:14
Ingredients:9
NDAs:15
Drug Master File Entries: (click here to view)15
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;ORAL022008-004Jun 13, 2008ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-006Apr 10, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Llc
AMERGE
naratriptan hydrochloride
TABLET;ORAL020763-002Feb 10, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 1995APRXYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL ODT
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL022251-004May 8, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-003Aug 24, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-002Aug 24, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
RYTHMOL SR
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-003Sep 4, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-002Sep 19, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Glaxosmithkline Llc

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
Eurasian Patent Organization008286► Subscribe
European Patent Office1524981► Subscribe
Peru08002003► Subscribe
Brazil0307319► Subscribe
Russian Federation2005105353► Subscribe
China1655768► Subscribe
TaiwanI342213► Subscribe
Denmark1474114► Subscribe
Colombia5680405► Subscribe
Japan5346021► 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
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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
C/GB99/008United Kingdom► SubscribePRODUCT 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
C0030France► SubscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
/1997Austria► SubscribePRODUCT 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
C0036Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
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
C0102Belgium► SubscribePRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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 500+ biopharmaceutical companies globally:

Healthtrust
Express Scripts
Fish and Richardson
Argus Health
Teva
Johnson and Johnson
Deloitte
McKinsey
Chubb
Cerilliant

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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