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Sevelamer hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for sevelamer hydrochloride?

Sevelamer hydrochloride is the generic ingredient in one branded drug marketed by Genzyme and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sevelamer hydrochloride has thirty-seven patent family members in thirty countries.

There are thirty-two drug master file entries for sevelamer hydrochloride. Five suppliers are listed for this compound.

Summary for Generic Name: sevelamer hydrochloride

Tradenames:1
Patents:2
Applicants:1
NDAs:2
Drug Master File Entries: see list32
Suppliers / Packagers: see list5
Bulk Api Vendors: see list26
Clinical Trials: see list1,015
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sevelamer hydrochloride at DailyMed

Pharmacology for Ingredient: sevelamer hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 2000RXYesNo6,733,780► SubscribeY ► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
CAPSULE;ORAL020926-001Oct 30, 1998DISCNNoNo► Subscribe► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 2000RXYesYes6,733,780► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sevelamer hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20007,014,846► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
CAPSULE;ORAL020926-001Oct 30, 19985,496,545► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20005,667,775► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20007,459,151► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20006,509,013► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sevelamer 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
8,187,631Direct compression polymer tablet core► 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: sevelamer hydrochloride

Country Document Number Estimated Expiration
Japan2016000753► Subscribe
Spain2235969► Subscribe
South Africa200202772► Subscribe
Turkey200201087► Subscribe
China1382041► 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: SEVELAMER HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00428Netherlands► SubscribePRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
2002Austria► SubscribePRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
C0011France► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606/01Switzerland► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
C/GB02/011United Kingdom► SubscribePRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
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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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