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Amgen Company Profile

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What is the competitive landscape for AMGEN, and what generic alternatives to AMGEN drugs are available?

AMGEN has two approved drugs.

There are seven US patents protecting AMGEN drugs.

Summary for Amgen

US Patents:	7
Tradenames:	2
Ingredients:	2
NDAs:	2
Patent Litigation for Amgen:	See patent lawsuits for Amgen
PTAB Cases with Amgen as patent owner:	See PTAB cases with Amgen as patent owner

Drugs and US Patents for Amgen

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	021688-002	Mar 8, 2004	AB	RX	Yes	No
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	AB	RX	Yes	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		RX	Yes	No	7,361,650		Y	Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	AB	RX	Yes	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		RX	Yes	Yes	7,867,996		Y	Y

Expired US Patents for Amgen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,011,068
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	6,031,003
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	6,011,068
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,031,003
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	6,313,146

Paragraph IV (Patent) Challenges for AMGEN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	30 mg, 60 mg and 90mg		2008-03-10

International Patents for Amgen Drugs

Country	Document Number	Estimated Expiration
China	1147459
Luxembourg	91182
Eurasian Patent Organization	013425
Australia	2004279318
Israel	173737

Supplementary Protection Certificates for Amgen Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
182	Luxembourg		91182, EXPIRES: 20191022
0199	Netherlands
C0029	France		PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
C/GB05/031	United Kingdom		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
2005 00027	Denmark

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Amgen
• Amgen Inc