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Last Updated: January 19, 2022

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SENSIPAR Drug Patent Profile


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When do Sensipar patents expire, and what generic alternatives are available?

Sensipar is a drug marketed by Amgen and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in twenty-nine countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Sensipar

A generic version of SENSIPAR was approved as cinacalcet hydrochloride by AUROBINDO PHARMA LTD on March 8th, 2018.

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Drug patent expirations by year for SENSIPAR
Drug Prices for SENSIPAR

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Recent Clinical Trials for SENSIPAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VA Office of Research and DevelopmentPhase 4
University of California, San FranciscoPhase 4
Peter VestergaardPhase 3

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Pharmacology for SENSIPAR
Paragraph IV (Patent) Challenges for SENSIPAR
Tradename Dosage Ingredient NDA Submissiondate
SENSIPAR TABLET;ORAL cinacalcet hydrochloride 021688 2008-03-10

US Patents and Regulatory Information for SENSIPAR

SENSIPAR is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting SENSIPAR

Rapid dissolution formulation of a calcium receptor-active compound
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA

Rapid dissolution formulation of a calcium receptor-active compound
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

FDA Regulatory Exclusivity protecting SENSIPAR

TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNABLE TO UNDERGO PARATHYROIDECTOMY.
Exclusivity Expiration: ⤷  Try it Free

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SENSIPAR

Supplementary Protection Certificates for SENSIPAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1203761 SPC020/2005 Ireland ⤷  Try it Free SPC020/2005: 20060407, EXPIRES: 20191021
1203761 300199 Netherlands ⤷  Try it Free
1203761 05C0029 France ⤷  Try it Free PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761 91182 Luxembourg ⤷  Try it Free 91182, EXPIRES: 20191022
1203761 CA 2005 00027 Denmark ⤷  Try it Free
1203761 SPC/GB05/031 United Kingdom ⤷  Try it Free PRODUCT NAME: CINACALCET OR A PHARMACEUTICALLY ACCEPTABLE SALT OR COMPLEX THEREOF; REGISTERED: UK EU/1/04/292/001 20041022; UK EU/1/04/292/002 20041022; UK EU/1/04/292/003 20041022; UK EU/1/04/292/004 20041022; UK EU/1/04/292/005 20041022; UK EU/1/04/292/006 20041022; UK EU/1/04/292/007 20041022; UK EU/1/04/292/008 20041022; UK EU/1/04/292/009 20041022; UK EU/1/04/292/010 20041022; UK EU/1/04/292/011 20041022; UK EU/1/04/292/012 20041022; UK EU/1/04/293/001 20041022; UK EU/1/04/293/002 20041022; UK EU/1/04/293/003 20041022; UK EU/1/04/293/004 20041022; UK EU/1/04/293/005 20041022; UK EU/1/04/293/006 20041022; UK EU/1/04/293/007 20041022; UK EU/1/04/293/008 20041022; UK EU/1/04/293/009 200410
1203761 C01203761/01 Switzerland ⤷  Try it Free PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Colorcon
Mallinckrodt
McKesson
Merck

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