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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 seven US patents protecting AMGEN drugs.

There are two hundred and thirty-six patent family members on AMGEN drugs in fifty countries and seven supplementary protection certificates in seven countries.

Summary for Amgen

International Patents:	236
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 Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		RX	Yes	Yes
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	AB	RX	Yes	Yes
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		RX	Yes	No
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		RX	Yes	No	7,361,649		Y	Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	AB	RX	Yes	No	6,011,068		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	021688-002	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	021688-001	Mar 8, 2004	6,313,146
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,313,146
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
Brazil	PI0600623
European Patent Office	1296142
Spain	2313581
Denmark	2821067
Costa Rica	8248

Supplementary Protection Certificates for Amgen Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2005 00027	Denmark
1203761/01	Switzerland		PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
182	Luxembourg		91182, EXPIRES: 20191022
C0029	France		PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
0199	Netherlands

Similar Applicant Names

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

• Amgen
• Amgen Inc