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Amgen Company Profile

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AMGEN has four approved drugs.

There are twenty-one US patents protecting AMGEN drugs.

There are two hundred and sixteen patent family members on AMGEN drugs in forty-eight countries and twelve supplementary protection certificates in twelve countries.

International Patents:	216
US Patents:	21
Tradenames:	3
Ingredients:	4
NDAs:	4
Patent Litigation for Amgen:	See patent lawsuits for Amgen
PTAB Cases with Amgen as petitioner:	See PTAB cases with Amgen as petitioner
PTAB Cases with Amgen as patent owner:	See PTAB cases with Amgen as patent owner

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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	7,879,842*PED	Start Trial			Y	Start Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014		RX	Yes	No	7,893,101	Start Trial	Y	Y		Start Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	AB	RX	Yes	No	9,375,405	Start Trial	Y			Start Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014		RX	Yes	No	7,659,302	Start Trial				Start Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014		RX	Yes	Yes	9,872,854	Start Trial				Start 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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,313,146	Start Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	6,211,244	Start Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	6,011,068	Start Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	6,031,003	Start Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	6,020,358	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	10 mg, 20 mg and30 mg	➤ Subscribe	2018-03-22
➤ Subscribe	Tablets	30 mg, 60 mg and 90mg	➤ Subscribe	2008-03-10

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Country	Patent Number	Estimated Expiration
Taiwan	I344363	Start Trial
Eurasian Patent Organization	200600322	Start Trial
Hungary	E034348	Start Trial
European Patent Office	3578175	Start Trial
Ukraine	86595	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	122019000070	Germany	Start Trial	PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690	37/2019	Austria	Start Trial	PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690	LUC00125	Luxembourg	Start Trial	PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690	C201930044	Spain	Start Trial	PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
1203761	05C0029	France	Start Trial	PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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