Takeda Pharmaceuticals U.S.A., Inc.

Registered sites: 7
Drug products: 221
Live patents: 239
Countries: 4
Base: Germany

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
Takeda GmbH	OranienburgGermany	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002807809
Takeda GmbH	Singen (Hohentwiel)Germany	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806542
Takeda Ireland Limited	BrayIreland	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002870748
Takeda Ireland Limited	DublinIreland	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3006687027
Takeda Pharmaceutical Company Limited	HikariJapan	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging	3004664162
Takeda Pharmaceutical Company Limited	Yodogawa-KuJapan	Analytical testing, Finished drug manufacture, Packaging	3002808311
Takeda Pharmaceuticals U.S.A., Inc.	Brooklyn Park, MNUnited States	Analytical testing, Active ingredient (API) manufacture	3013514239

Alert

Products in shortage

Drug	Presentation	Availability
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 50 mg (NDC 59417-105-10)	Available
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 40 mg (NDC 59417-104-10)	Available
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 30 mg (NDC 59417-103-10)	Available
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 20 mg (NDC 59417-102-10)	Available
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 70 mg (NDC 59417-107-10)	Available
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 10 mg (NDC 59417-101-10)	Available
Lisdexamfetamine Dimesylate Capsule	Vyvanse, Capsule, 60 mg (NDC 59417-106-10)	Available
Lisdexamfetamine Dimesylate Tablet, Chewable	Vyvanse, Tablet, Chewable, 40 mg (NDC 59417-118-01)	Available
Lisdexamfetamine Dimesylate Tablet, Chewable	Vyvanse, Tablet, Chewable, 10 mg (NDC 59417-115-01)	Available
Lisdexamfetamine Dimesylate Tablet, Chewable	Vyvanse, Tablet, Chewable, 60 mg (NDC 59417-120-01)	Available
Lisdexamfetamine Dimesylate Tablet, Chewable	Vyvanse, Tablet, Chewable, 30 mg (NDC 59417-117-01)	Available
Lisdexamfetamine Dimesylate Tablet, Chewable	Vyvanse, Tablet, Chewable, 20 mg (NDC 59417-116-01)	Available
Lisdexamfetamine Dimesylate Tablet, Chewable	Vyvanse, Tablet, Chewable, 50 mg (NDC 59417-119-01)	Available

Exclusivity

Patents

239

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

Product	Active ingredient	Expiry
ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	Jan 2027
ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	Feb 2029
ALUNBRIG	BRIGATINIB	May 2029
ALUNBRIG	BRIGATINIB	Apr 2031
ALUNBRIG	BRIGATINIB	Apr 2034
ALUNBRIG	BRIGATINIB	Nov 2035
COLCRYS	COLCHICINE	Oct 2028
COLCRYS	COLCHICINE	Dec 2028
COLCRYS	COLCHICINE	Feb 2029
COLCRYS	COLCHICINE	Feb 2029
DEXILANT	DEXLANSOPRAZOLE	Sept 2026
DEXILANT	DEXLANSOPRAZOLE	Feb 2027
DEXILANT	DEXLANSOPRAZOLE	Mar 2027
DEXILANT	DEXLANSOPRAZOLE	Jan 2028
DEXILANT	DEXLANSOPRAZOLE	Mar 2030
DEXILANT	DEXLANSOPRAZOLE	Sept 2030
DEXILANT	DEXLANSOPRAZOLE	Mar 2032
DEXILANT SOLUTAB	DEXLANSOPRAZOLE	Jan 2028
DEXILANT SOLUTAB	DEXLANSOPRAZOLE	Jul 2028
DEXILANT SOLUTAB	DEXLANSOPRAZOLE	Mar 2029
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	Jan 2027
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	Jun 2028
EOHILIA	BUDESONIDE	Nov 2026
EOHILIA	BUDESONIDE	Nov 2028
EOHILIA	BUDESONIDE	Nov 2028
EOHILIA	BUDESONIDE	Aug 2029
EOHILIA	BUDESONIDE	Aug 2029
EOHILIA	BUDESONIDE	Jan 2039
EXKIVITY	MOBOCERTINIB SUCCINATE	May 2035
FOSRENOL	LANTHANUM CARBONATE	Dec 2030
FRUZAQLA	FRUQUINTINIB	May 2028
FRUZAQLA	FRUQUINTINIB	Mar 2032
FRUZAQLA	FRUQUINTINIB	Sept 2035
ICLUSIG	PONATINIB HYDROCHLORIDE	Dec 2026
ICLUSIG	PONATINIB HYDROCHLORIDE	Jan 2027
ICLUSIG	PONATINIB HYDROCHLORIDE	Dec 2033
KAZANO	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE	Jun 2028
KAZANO	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE	May 2029
LIVTENCITY	MARIBAVIR	Oct 2031
LIVTENCITY	MARIBAVIR	Jan 2032
LIVTENCITY	MARIBAVIR	Nov 2042
LIVTENCITY	MARIBAVIR	Oct 2043
MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	Aug 2029
NESINA	ALOGLIPTIN BENZOATE	Jun 2028
NESINA	ALOGLIPTIN BENZOATE	Jun 2029
NINLARO	IXAZOMIB CITRATE	Aug 2027
NINLARO	IXAZOMIB CITRATE	Jun 2029
NINLARO	IXAZOMIB CITRATE	Nov 2029
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	Jun 2028
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	Jun 2029
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Dec 2026
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Jun 2027
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Dec 2027
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Jun 2031
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Dec 2031
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Mar 2032
TRINTELLIX	VORTIOXETINE HYDROBROMIDE	Sept 2032
ULORIC	FEBUXOSTAT	Sept 2031

Catalogue

Marketed products

221

Showing 150 of 221.

Brand	Generic name	Form	Category
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADVATE	Antihemophilic Factor (Recombinant)	KIT	BLA
ADZYNMA	Apadamtase Alfa	KIT	BLA
ADZYNMA	Apadamtase Alfa	KIT	BLA
Actoplus Met	pioglitazone and metformin hydrochloride	TABLET, FILM COATED	NDA
Actos	pioglitazone	TABLET	NDA
Actos	pioglitazone	TABLET	NDA
Actos	pioglitazone	TABLET	NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	CAPSULE, EXTENDED RELEASE	NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	CAPSULE, EXTENDED RELEASE	NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	CAPSULE, EXTENDED RELEASE	NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	CAPSULE, EXTENDED RELEASE	NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	CAPSULE, EXTENDED RELEASE	NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	CAPSULE, EXTENDED RELEASE	NDA
Agrylin	anagrelide hydrochloride	CAPSULE	NDA
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
Alunbrig	brigatinib	TABLET, FILM COATED	NDA
Alunbrig	brigatinib	TABLET, FILM COATED	NDA
Alunbrig	brigatinib	TABLET, FILM COATED	NDA
Alunbrig	brigatinib	KIT	NDA
Amitiza	lubiprostone	CAPSULE, GELATIN COATED	NDA
Amitiza	lubiprostone	CAPSULE, GELATIN COATED	NDA
Aralast NP	Alpha-1-Proteinase Inhibitor (Human)	KIT	BLA
Aralast NP	Alpha-1-Proteinase Inhibitor (Human)	KIT	BLA
-	Azilsartan kamedoxomil	TABLET	DRUG FOR FURTHER PROCESSING
-	Azilsartan kamedoxomil	TABLET	DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil	TABLET	DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil	TABLET	DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil and CHLORTHALIDONE	TABLET	DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil and CHLORTHALIDONE	TABLET	DRUG FOR FURTHER PROCESSING
-	Bictegravir sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate	TABLET	DRUG FOR FURTHER PROCESSING
CEPROTIN	Protein C Concentrate Human	KIT	BLA
CEPROTIN	Protein C Concentrate Human	KIT	BLA
CUVITRU	Immune Globulin Subcutaneous (Human)	INJECTION, SOLUTION	BLA
Carbatrol	carbamazepine	CAPSULE, EXTENDED RELEASE	NDA
Carbatrol	carbamazepine	CAPSULE, EXTENDED RELEASE	NDA
Carbatrol	carbamazepine	CAPSULE, EXTENDED RELEASE	NDA
Cinryze	HUMAN C1-ESTERASE INHIBITOR	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Cinryze	HUMAN C1-ESTERASE INHIBITOR	KIT	BLA
-	Colchicine	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
Dexilant	dexlansoprazole	CAPSULE, DELAYED RELEASE	NDA
Dexilant	dexlansoprazole	CAPSULE, DELAYED RELEASE	NDA
Duetact	pioglitazone and glimepiride	TABLET	NDA
Duetact	pioglitazone and glimepiride	TABLET	NDA
ELAPRASE	idursulfase	SOLUTION, CONCENTRATE	BLA
ENTYVIO	vedolizumab	INJECTION, SOLUTION	BLA
ENTYVIO Pen	vedolizumab	INJECTION, SOLUTION	BLA
Entyvio	vedolizumab	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Eohilia	Budesonide	SUSPENSION	NDA
FEIBA	anti-inhibitor coagulant complex	KIT	BLA
FEIBA	anti-inhibitor coagulant complex	KIT	BLA
FEIBA	anti-inhibitor coagulant complex	KIT	BLA
FLEXBUMIN	Albumin Human	SOLUTION	BLA
Firazyr	icatibant acetate	INJECTION, SOLUTION	NDA
Flexbumin	Albumin Human	INJECTION, SOLUTION	BLA
Fosrenol	lanthanum carbonate	TABLET, CHEWABLE	NDA
Fosrenol	lanthanum carbonate	TABLET, CHEWABLE	NDA
Fosrenol	lanthanum carbonate	TABLET, CHEWABLE	NDA
Fosrenol	lanthanum carbonate	POWDER	NDA
Fosrenol	lanthanum carbonate	POWDER	NDA
Fruzaqla	fruquintinib	CAPSULE	NDA
Fruzaqla	fruquintinib	CAPSULE	NDA
GAMMAGARD Liquid	Immune Globulin Infusion (Human)	INJECTION, SOLUTION	BLA
GAMMAGARD Liquid ERC	Immune Globulin Infusion (Human)	INJECTION, SOLUTION	BLA
GAMMAGARD S/D	Immune Globulin Intravenous (Human)	KIT	BLA
GAMMAGARD S/D	Immune Globulin Intravenous (Human)	KIT	BLA
GLASSIA	ALPHA.1-PROTEINASE INHIBITOR HUMAN	INJECTION, SOLUTION	BLA
Gattex	teduglutide	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	NDA
Gattex	teduglutide	KIT	NDA
Gattex	teduglutide	KIT	NDA
HEMOFIL M	antihemophilic factor human	KIT	BLA
HEMOFIL M	antihemophilic factor human	KIT	BLA
HEMOFIL M	antihemophilic factor human	KIT	BLA
HEMOFIL M	antihemophilic factor human	KIT	BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	KIT	BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	KIT	BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	KIT	BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	KIT	BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	KIT	BLA
Iclusig	ponatinib hydrochloride	TABLET, FILM COATED	NDA
Iclusig	ponatinib hydrochloride	TABLET, FILM COATED	NDA
Iclusig	ponatinib hydrochloride	TABLET, FILM COATED	NDA
Iclusig	ponatinib hydrochloride	TABLET, FILM COATED	NDA
Intuniv	guanfacine	TABLET, EXTENDED RELEASE	NDA
Intuniv	guanfacine	TABLET, EXTENDED RELEASE	NDA
Intuniv	guanfacine	TABLET, EXTENDED RELEASE	NDA
Intuniv	guanfacine	TABLET, EXTENDED RELEASE	NDA
KAZANO	alogliptin and metformin hydrochloride	TABLET, FILM COATED	NDA
KAZANO	alogliptin and metformin hydrochloride	TABLET, FILM COATED	NDA
Kalbitor	Ecallantide	INJECTION, SOLUTION	BLA
Lialda	mesalamine	TABLET, DELAYED RELEASE	NDA
Livtencity	MARIBAVIR	TABLET, COATED	NDA
MOTEGRITY	PRUCALOPRIDE	TABLET, FILM COATED	NDA
MOTEGRITY	PRUCALOPRIDE	TABLET, FILM COATED	NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE	NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE	NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE	NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE	NDA
Mesalamine	MESALAMINE	TABLET, DELAYED RELEASE	NDA AUTHORIZED GENERIC
NINLARO	ixazomib	CAPSULE	NDA
NINLARO	ixazomib	CAPSULE	NDA
NINLARO	ixazomib	CAPSULE	NDA
Nesina	alogliptin	TABLET, FILM COATED	NDA
Nesina	alogliptin	TABLET, FILM COATED	NDA
Nesina	alogliptin	TABLET, FILM COATED	NDA
OBIZUR	Antihemophilic Factor (Recombinant), Porcine Sequence	KIT	BLA
OSENI	alogliptin and pioglitazone	TABLET, FILM COATED	NDA
OSENI	alogliptin and pioglitazone	TABLET, FILM COATED	NDA
OSENI	alogliptin and pioglitazone	TABLET, FILM COATED	NDA
OSENI	alogliptin and pioglitazone	TABLET, FILM COATED	NDA
-	PANTOPRAZOLE SODIUM	TABLET, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	PANTOPRAZOLE SODIUM	TABLET, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	PANTOPRAZOLE SODIUM	INJECTION, POWDER, FOR SOLUTION	DRUG FOR FURTHER PROCESSING
Pentasa	mesalamine	CAPSULE	NDA
Pentasa	mesalamine	CAPSULE	NDA
Prevacid	lansoprazole	CAPSULE, DELAYED RELEASE	NDA
Prevacid SoluTab	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	NDA
Prevacid SoluTab	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	NDA
RECOMBINATE	antihemophilic factor recombinant	KIT	BLA
RECOMBINATE	antihemophilic factor recombinant	KIT	BLA
RECOMBINATE	antihemophilic factor recombinant	KIT	BLA
RECOMBINATE	antihemophilic factor recombinant	KIT	BLA
RECOMBINATE	antihemophilic factor recombinant	KIT	BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	KIT	BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	KIT	BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	KIT	BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	KIT	BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	KIT	BLA
Rozerem	ramelteon	TABLET, FILM COATED	NDA
TAKHZYRO	lanadelumab-flyo	INJECTION, SOLUTION	BLA
TAKHZYRO	lanadelumab-flyo	SOLUTION	BLA
TAKHZYRO	lanadelumab-flyo	SOLUTION	BLA
-	TENOFOVIR DISOPROXIL FUMARATE	TABLET, COATED	DRUG FOR FURTHER PROCESSING
Trintellix	vortioxetine	TABLET, FILM COATED	NDA
Trintellix	vortioxetine	TABLET, FILM COATED	NDA
Trintellix	vortioxetine	TABLET, FILM COATED	NDA
ULORIC	febuxostat	TABLET	NDA
ULORIC	febuxostat	TABLET	NDA
-	VEDOLIZUMAB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	DRUG FOR FURTHER PROCESSING
-	VEDOLIZUMAB	LIQUID	BULK INGREDIENT
-	VEDOLIZUMAB	LIQUID	BULK INGREDIENT
VELCADE	bortezomib	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	NDA

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.