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Serving 500+ biopharmaceutical companies globally:

McKinsey
Fuji
Merck
UBS
Argus Health
Accenture
Julphar
Johnson and Johnson
Colorcon
Cipla

Generated: September 19, 2017

DrugPatentWatch Database Preview

Amgen Company Profile

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What is the competitive landscape for AMGEN, and when can generic versions of AMGEN drugs launch?

AMGEN has two approved drugs.

There are nine US patents protecting AMGEN drugs.

There are two hundred and thirty-five patent family members on AMGEN drugs in forty-nine countries.

Summary for Applicant: Amgen

Patents:9
Tradenames:2
Ingredients:2
NDAs:2
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;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYesYes► Subscribe► SubscribeYY ► 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;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Amgen Inc
CORLANOR
ivabradine hydrochloride
TABLET;ORAL206143-001Apr 15, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-003Mar 8, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Amgen Inc
CORLANOR
ivabradine hydrochloride
TABLET;ORAL206143-001Apr 15, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Amgen
SENSIPAR
cinacalcet hydrochloride
TABLET;ORAL021688-002Mar 8, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Amgen

Paragraph IV activity for AMGEN drugs

Drugname Dosage Strength Tradename Submissiondate
cinacalcet hydrochloride
Tablets30 mg, 60 mg and 90mg
SENSIPAR
3/10/2008

Non-Orange Book Patents for Amgen

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
5,763,569 Calcium receptor-active molecules► Subscribe
5,688,938 Calcium receptor-active molecules► Subscribe
6,211,244 Calcium receptor-active compounds► 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 Amgen Drugs

Country Document Number Estimated Expiration
China1534016► Subscribe
African Regional IP Organization (ARIPO)1907► Subscribe
JapanH09281109► Subscribe
Georgia, Republic ofP20084467► Subscribe
Singapore125229► Subscribe
Australia675891► Subscribe
Eurasian Patent Organization200600320► Subscribe
MexicoPA06002616► Subscribe
Taiwan568896► Subscribe
Israel173959► 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 Amgen Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0199Netherlands► Subscribe
C0029France► SubscribePRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761/01Switzerland► SubscribePRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
2005 00027Denmark► Subscribe
C020/2005Ireland► SubscribeSPC020/2005: 20060407, EXPIRES: 20191021
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
182Luxembourg► Subscribe91182, EXPIRES: 20191022
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving 500+ biopharmaceutical companies globally:

Moodys
US Department of Justice
McKesson
QuintilesIMS
Covington
Fish and Richardson
Mallinckrodt
Cipla
Colorcon
Merck

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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