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SENSIPAR Drug Profile

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Sensipar is a drug marketed by Amgen and is included in one NDA. It is available from six suppliers. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in thirty-three countries.

The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Six suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the cinacalcet hydrochloride profile page.

Summary for Tradename: SENSIPAR

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Drug Prices: :see details

Pharmacology for Tradename: SENSIPAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-001Mar 8, 2004RXNo6,031,003► subscribe ► subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYes6,211,244► subscribeYY ► subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYes► subscribe► subscribe
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Expired Patents for Tradename: SENSIPAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-001Mar 8, 20046,211,244► subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 20046,211,244► subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 20046,211,244► subscribe
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Paragraph IV activity for: SENSIPAR

Drugname Dosage Strength RLD Submissiondate
cinacalcet hydrochlorideTablets30 mg, 60 mg and 90mgSensipar3/10/2008

Non-Orange Book Patents for Tradename: SENSIPAR

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
5,391,210 Abrasive article► subscribe
5,962,314 Calcium receptor-active molecules► subscribe
5,858,684 Method of screening calcium receptor-active molecules► 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 Tradename: SENSIPAR

Country Document Number Estimated Expiration
Japan2001220356► subscribe
Norway940581► subscribe
JapanH11221095► 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: SENSIPAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0029France► subscribePRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
0199Netherlands► subscribe
C020/2005Ireland► subscribeSPC020/2005: 20060407, EXPIRES: 20191021
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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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