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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Express Scripts
Argus Health
Fuji
Julphar
AstraZeneca
Novartis
US Army
Teva

Generated: September 26, 2017

DrugPatentWatch Database Preview

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 five 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 forty-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 Generic Name: cinacalcet hydrochloride

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list24
Suppliers / Packagers: see list6
Bulk Api Vendors: see list54
Clinical Trials: see list2,323
Patent Applications: see list22
Therapeutic Class:Hormonal Agents, Suppressant (Parathyroid)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cinacalcet hydrochloride at DailyMed

Pharmacology for Ingredient: cinacalcet hydrochloride

Tentative approvals for CINACALCET HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe30MGTABLET; ORAL
► Subscribe► Subscribe90MGTABLET; ORAL
► Subscribe► Subscribe60MGTABLET; ORAL
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;ORAL021688-001Mar 8, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYesYes► Subscribe► SubscribeYY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-001Mar 8, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-001Mar 8, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYesYes► Subscribe► Subscribe ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cinacalcet hydrochloride

Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
6,211,244 Calcium receptor-active compounds► Subscribe
5,858,684 Method of screening calcium receptor-active molecules► Subscribe
5,763,569 Calcium receptor-active molecules► Subscribe
5,962,314 Calcium receptor-active molecules► Subscribe
5,688,938 Calcium receptor-active molecules► Subscribe
6,001,884 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 Ingredient: cinacalcet hydrochloride

Country Document Number Estimated Expiration
Australia1014100► Subscribe
Hong Kong1012620► Subscribe
Taiwan200518743► Subscribe
South Korea20070017460► Subscribe
Germany122005000033► Subscribe
Hong Kong1020041► Subscribe
Germany69233586► Subscribe
Hungary229474► Subscribe
TaiwanI344363► Subscribe
Portugal1663182► 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: CINACALCET HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0029France► SubscribePRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
182Luxembourg► Subscribe91182, EXPIRES: 20191022
2005 00027Denmark► Subscribe
C/GB05/031United Kingdom► SubscribePRODUCT 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
1203761/01Switzerland► SubscribePRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
0199Netherlands► Subscribe
C020/2005Ireland► SubscribeSPC020/2005: 20060407, EXPIRES: 20191021
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Fuji
Novartis
Colorcon
Queensland Health
Covington
QuintilesIMS
Farmers Insurance
UBS

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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