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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Fuji
Covington
Cipla
Teva
Julphar
Chinese Patent Office
Harvard Business School
US Army

Generated: February 24, 2018

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Cinacalcet hydrochloride - Generic Drug Details

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What are the generic sources for cinacalcet hydrochloride and what is the scope of cinacalcet hydrochloride freedom to operate?

Cinacalcet hydrochloride
is the generic ingredient in one branded drug marketed by Amgen and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cinacalcet hydrochloride has one hundred and fifty-four patent family members in thirty-four countries.

There are twenty-four drug master file entries for cinacalcet hydrochloride. Six suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for cinacalcet hydrochloride
Pharmacology for cinacalcet hydrochloride
Medical Subject Heading (MeSH) Categories for cinacalcet hydrochloride
Tentative approvals for CINACALCET HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial30MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial90MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial60MGTABLET; ORAL

US Patents and Regulatory Information for cinacalcet hydrochloride

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

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Expired US Patents for cinacalcet hydrochloride

Non-Orange Book US Patents for cinacalcet 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
5,391,210 Abrasive article ➤ Try a Free Trial
5,858,684 Method of screening calcium receptor-active molecules ➤ Try a Free Trial
6,313,146 Calcium receptor-active molecules ➤ Try a Free Trial
5,962,314 Calcium receptor-active molecules ➤ Try a Free Trial
6,031,003 Calcium receptor-active molecules ➤ Try a Free Trial
6,211,244 Calcium receptor-active compounds ➤ Try a Free Trial
6,001,884 Calcium receptor-active molecules ➤ Try a Free Trial
5,688,938 Calcium receptor-active molecules ➤ Try a Free Trial
5,763,569 Calcium receptor-active molecules ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for cinacalcet hydrochloride

Supplementary Protection Certificates for cinacalcet hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0029 France ➤ Try a Free Trial PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
0199 Netherlands ➤ Try a Free Trial
1203761/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
182 Luxembourg ➤ Try a Free Trial 91182, EXPIRES: 20191022
C020/2005 Ireland ➤ Try a Free Trial SPC020/2005: 20060407, EXPIRES: 20191021
2005 00027 Denmark ➤ Try a Free Trial
C/GB05/031 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
US Army
Farmers Insurance
Medtronic
Teva
AstraZeneca
Cantor Fitzgerald
Harvard Business School

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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