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Serving 500+ biopharmaceutical companies globally:

Deloitte
Julphar
Cantor Fitzgerald
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Farmers Insurance
QuintilesIMS
Covington
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Generated: July 25, 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.

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
ropinirole hydrochloride
TABLET;ORAL020658-002Sep 19, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL ODT
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL022251-002May 8, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Llc
RYTHMOL SR
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-003Sep 4, 2003ABRXYesYes► 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
LANOXICAPS
digoxin
CAPSULE;ORAL018118-004Sep 24, 1984► Subscribe► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline Llc
REQUIP
ropinirole hydrochloride
TABLET;ORAL020658-005Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-004Sep 8, 2000► Subscribe► Subscribe
Glaxosmithkline Llc
LANOXICAPS
digoxin
CAPSULE;ORAL018118-001Jul 26, 1982► 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
Germany60134964► Subscribe
Argentina068185► Subscribe
Taiwan200911267► Subscribe
Malaysia139719► Subscribe
Malaysia141049► 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
C0036Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
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
C/GB96/040United Kingdom► SubscribePRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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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:

Mallinckrodt
US Department of Justice
Citi
QuintilesIMS
Harvard Business School
Accenture
AstraZeneca
Queensland Health
Chubb
Moodys

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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