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Serving 500+ biopharmaceutical companies globally:

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Generated: July 22, 2017

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Colesevelam hydrochloride - Generic Drug Details

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What are the generic sources for colesevelam hydrochloride and what is the scope of colesevelam hydrochloride patent protection?

Colesevelam hydrochloride
is the generic ingredient in one branded drug marketed by Daiichi Sankyo and is included in three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colesevelam hydrochloride has fifty-eight patent family members in sixteen countries.

There are ten drug master file entries for colesevelam hydrochloride. Five suppliers are listed for this compound.

Summary for Generic Name: colesevelam hydrochloride

Tradenames:1
Patents:2
Applicants:1
NDAs:3
Drug Master File Entries: see list10
Suppliers / Packagers: see list5
Clinical Trials: see list2,281
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:colesevelam hydrochloride at DailyMed

Pharmacology for Ingredient: colesevelam hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
FOR SUSPENSION;ORAL022362-002Oct 2, 2009RXYesYes7,229,613*PED► SubscribeY► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
FOR SUSPENSION;ORAL022362-001Oct 2, 2009RXYesNo7,229,613*PED► SubscribeY► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
TABLET;ORAL021176-001May 26, 2000RXYesYes7,229,613*PED► SubscribeY► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
CAPSULE;ORAL021141-001May 26, 2000DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: colesevelam hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
FOR SUSPENSION;ORAL022362-001Oct 2, 20095,917,007*PED► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
TABLET;ORAL021176-001May 26, 20007,101,960*PED► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
FOR SUSPENSION;ORAL022362-002Oct 2, 20095,693,675*PED► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
TABLET;ORAL021176-001May 26, 20005,693,675*PED► Subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
CAPSULE;ORAL021141-001May 26, 20005,917,007*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: colesevelam hydrochloride

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
7,261,880Methods of treating Syndrome X with aliphatic polyamines► Subscribe
8,377,428Low salt forms of polyallylamine► Subscribe
7,541,024Low salt forms of polyallylamine► 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 Ingredient: colesevelam hydrochloride

Country Document Number Estimated Expiration
Brazil0209020► Subscribe
Japan2010111704► Subscribe
Japan2004526778► Subscribe
World Intellectual Property Organization (WIPO)02085377► Subscribe
Denmark1392331► 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 Tradename: COLESEVELAM HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00159Netherlands► SubscribePRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
C0021France► SubscribePRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
C/GB04/031United Kingdom► SubscribePRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Cipla
Daiichi Sankyo
Federal Trade Commission
Express Scripts
Mallinckrodt
Teva
US Department of Justice
Covington
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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