Amgen, Inc

Registered sites: 9
Drug products: 105
Live patents: 64
Countries: 4
Base: United States

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging

Sites

Facilities

Site	Location	Operations	FEI
Amgen Technology (ireland) Unlimited Company	Pottery RoadIreland	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002808497
Horizon Therapeutics Ireland Designated Activity Company (DAC)	WaterfordIreland	Analytical testing, Finished drug manufacture	3020007539
Amgen Europe BV	NBNTNetherlands	Analytical testing, Labelling, Finished drug manufacture, Packaging	3005889661
Amgen Singapore Manufacturing Pte. Ltd.	SingaporeSingapore	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3011255424
Amgen Manufacturing Limited LLC	Juncos, PRUnited States	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	1000110364
Amgen Inc.	Louisville, KYUnited States	Labelling, Packaging	3003750095
Amgen Inc.	New Albany, OHUnited States	Analytical testing, Labelling, Packaging	3020740318
Amgen, Inc	Thousand Oaks, CAUnited States	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	2026154
Immunex Rhode Island Corporation	West Greenwich, RIUnited States	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3003359885

Exclusivity

Patents

Unexpired Orange Book patents where this company is the application holder.

Product	Active ingredient	Expiry
CORLANOR	IVABRADINE HYDROCHLORIDE	Aug 2026
CORLANOR	IVABRADINE HYDROCHLORIDE	Dec 2026
CORLANOR	IVABRADINE HYDROCHLORIDE	Jun 2027
LUMAKRAS	SOTORASIB	May 2038
LUMAKRAS	SOTORASIB	Nov 2039
LUMAKRAS	SOTORASIB	May 2040
LUMAKRAS	SOTORASIB	Sept 2040
OTEZLA	APREMILAST	Feb 2028
OTEZLA	APREMILAST	Aug 2028
OTEZLA	APREMILAST	Nov 2033
OTEZLA	APREMILAST	May 2034
OTEZLA	APREMILAST	May 2034
OTEZLA	APREMILAST	Nov 2034
OTEZLA XR	APREMILAST	Feb 2028
OTEZLA XR	APREMILAST	May 2034
OTEZLA XR	APREMILAST	May 2042
SENSIPAR	CINACALCET HYDROCHLORIDE	Sept 2026

Catalogue

Marketed products

105

Showing 105 of 105.

Brand	Generic name	Form	Category
AIMOVIG	erenumab-aooe	INJECTION	BLA
AIMOVIG	erenumab-aooe	INJECTION	BLA
AIMOVIG	erenumab-aooe	INJECTION, SOLUTION	BLA
AIMOVIG	erenumab-aooe	INJECTION, SOLUTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
AMJEVITA	adalimumab-atto	INJECTION	BLA
ARANESP	darbepoetin alfa	SOLUTION	BLA
ARANESP	darbepoetin alfa	SOLUTION	BLA
ARANESP	darbepoetin alfa	SOLUTION	BLA
ARANESP	darbepoetin alfa	SOLUTION	BLA
ARANESP	darbepoetin alfa	SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
ARANESP	darbepoetin alfa	INJECTION, SOLUTION	BLA
AVSOLA	infliximab-axxq	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
BKEMV	eculizumab-aeeb	INJECTION, SOLUTION, CONCENTRATE	BLA
BLINCYTO	blinatumomab	KIT	BLA
-	Brodalumab	SOLUTION	DRUG FOR FURTHER PROCESSING
Corlanor	ivabradine	TABLET, FILM COATED	NDA
Corlanor	ivabradine	TABLET, FILM COATED	NDA
Corlanor	ivabradine	SOLUTION	NDA
EPOGEN	epoetin alfa	SOLUTION	BLA
EPOGEN	epoetin alfa	SOLUTION	BLA
EPOGEN	epoetin alfa	SOLUTION	BLA
EPOGEN	epoetin alfa	SOLUTION	BLA
EPOGEN	epoetin alfa	SOLUTION	BLA
EPOGEN	epoetin alfa	SOLUTION	BLA
Evenity	romosozumab-aqqg	INJECTION, SOLUTION	BLA
Evenity	romosozumab-aqqg	INJECTION, SOLUTION	BLA
Evenity	romosozumab-aqqg	INJECTION, SOLUTION	BLA
IMDELLTRA (AMG757)	Tarlatamab-dlle	KIT	BLA
IMDELLTRA (AMG757)	Tarlatamab-dlle	KIT	BLA
Imlygic	talimogene laherparepvec	INJECTION, SUSPENSION	BLA
Imlygic	talimogene laherparepvec	INJECTION, SUSPENSION	BLA
Kanjinti	trastuzumab-anns	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Kanjinti	trastuzumab-anns	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
LUMAKRAS	sotorasib	TABLET, COATED	NDA
LUMAKRAS	sotorasib	TABLET, COATED	NDA
LUMAKRAS	sotorasib	TABLET, COATED	NDA
MVASI	bevacizumab-awwb	INJECTION, SOLUTION	BLA
MVASI	bevacizumab-awwb	INJECTION, SOLUTION	BLA
NEUPOGEN	Filgrastim	INJECTION, SOLUTION	BLA
NEUPOGEN	Filgrastim	INJECTION, SOLUTION	BLA
NEUPOGEN	Filgrastim	INJECTION, SOLUTION	BLA
NEUPOGEN	Filgrastim	INJECTION, SOLUTION	BLA
Neulasta	pegfilgrastim	SOLUTION	BLA
Neulasta	pegfilgrastim	INJECTION	BLA
Neulasta	pegfilgrastim	KIT	BLA
Nplate	romiplostim	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Nplate	romiplostim	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Nplate	romiplostim	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Otezla	apremilast	TABLET, FILM COATED	NDA
Otezla	apremilast	KIT	NDA
Otezla	apremilast	KIT	NDA
Otezla	apremilast	TABLET, FILM COATED	NDA
Otezla	apremilast	KIT	NDA
Otezla	apremilast	KIT	NDA
Otezla	apremilast	TABLET, FILM COATED	NDA
Otezla	apremilast	KIT	NDA
PARSABIV	etelcalcetide	INJECTION, SOLUTION	NDA
PARSABIV	etelcalcetide	INJECTION, SOLUTION	NDA
PARSABIV	etelcalcetide	INJECTION, SOLUTION	NDA
PAVBLU	aflibercept-ayyh	INJECTION, SOLUTION	BLA
PAVBLU	aflibercept-ayyh	INJECTION, SOLUTION	BLA
Prolia	denosumab	INJECTION	BLA
REPATHA	Evolocumab	INJECTION, SOLUTION	BLA
REPATHA	Evolocumab	INJECTION, SOLUTION	BLA
REPATHA	Evolocumab	INJECTION, SOLUTION	BLA
REPATHA	Evolocumab	INJECTION, SOLUTION	BLA
REPATHA	Evolocumab	INJECTION, SOLUTION	BLA
Riabni	rituximab-arrx	INJECTION, SOLUTION	BLA
Riabni	rituximab-arrx	INJECTION, SOLUTION	BLA
Sensipar	cinacalcet hydrochloride	TABLET, COATED	NDA
Sensipar	cinacalcet hydrochloride	TABLET, COATED	NDA
Sensipar	cinacalcet hydrochloride	TABLET, COATED	NDA
TEZSPIRE	tezepelumab-ekko	INJECTION, SOLUTION	BLA
TEZSPIRE	tezepelumab-ekko	INJECTION, SOLUTION	BLA
Vectibix	panitumumab	SOLUTION	BLA
Vectibix	panitumumab	SOLUTION	BLA
XGEVA	denosumab	INJECTION	BLA
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING
-	epoetin alfa	SOLUTION	DRUG FOR FURTHER PROCESSING

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.