Genentech, Inc.

Registered sites: 8
Drug products: 93
Live patents: 124
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
F. Hoffmann-La Roche AG	BaselSwitzerland	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002807200
F. Hoffmann-La Roche AG	KaiseraugstSwitzerland	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3003973536
Roche Diagnostics GmbH	MannheimGermany	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002806559
Roche Diagnostics GmbH	PenzbergGermany	Analytical testing, Active ingredient (API) manufacture	3002806560
Roche Singapore Technical Operations Pte. Ltd.	SingaporeSingapore	Analytical testing, Active ingredient (API) manufacture	3007164129
Genentech, Inc.	Hillsboro, ORUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	3007232634
Genentech, Inc.	Oceanside, CAUnited States	Analytical testing, Active ingredient (API) manufacture	3006129086
Genentech, Inc.	South San Francisco, CAUnited States	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	2917293

Exclusivity

Patents

124

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

Product	Active ingredient	Expiry
COTELLIC	COBIMETINIB FUMARATE	Oct 2026
COTELLIC	COBIMETINIB FUMARATE	Apr 2027
COTELLIC	COBIMETINIB FUMARATE	Nov 2029
COTELLIC	COBIMETINIB FUMARATE	May 2030
COTELLIC	COBIMETINIB FUMARATE	Jun 2034
COTELLIC	COBIMETINIB FUMARATE	Dec 2034
COTELLIC	COBIMETINIB FUMARATE	Jun 2036
COTELLIC	COBIMETINIB FUMARATE	Jun 2036
COTELLIC	COBIMETINIB FUMARATE	Dec 2036
COTELLIC	COBIMETINIB FUMARATE	Dec 2036
ERIVEDGE	VISMODEGIB	Nov 2028
ERIVEDGE	VISMODEGIB	Dec 2028
EVRYSDI	RISDIPLAM	Feb 2033
EVRYSDI	RISDIPLAM	May 2035
EVRYSDI	RISDIPLAM	Jan 2036
EVRYSDI	RISDIPLAM	Nov 2036
EVRYSDI	RISDIPLAM	Oct 2038
EVRYSDI	RISDIPLAM	Oct 2038
EVRYSDI	RISDIPLAM	Apr 2041
ITOVEBI	INAVOLISIB	Sept 2030
ITOVEBI	INAVOLISIB	Jul 2036
ITOVEBI	INAVOLISIB	Apr 2038
ITOVEBI	INAVOLISIB	Jun 2038
ROZLYTREK	ENTRECTINIB	Jul 2028
ROZLYTREK	ENTRECTINIB	Mar 2032
ROZLYTREK	ENTRECTINIB	May 2033
ROZLYTREK	ENTRECTINIB	Feb 2035
ROZLYTREK	ENTRECTINIB	Feb 2035
ROZLYTREK	ENTRECTINIB	May 2037
ROZLYTREK	ENTRECTINIB	Jul 2038
XOFLUZA	BALOXAVIR MARBOXIL	Jun 2030
XOFLUZA	BALOXAVIR MARBOXIL	May 2031
XOFLUZA	BALOXAVIR MARBOXIL	Oct 2032
XOFLUZA	BALOXAVIR MARBOXIL	Apr 2036
XOFLUZA	BALOXAVIR MARBOXIL	Aug 2037
XOFLUZA	BALOXAVIR MARBOXIL	Sept 2038
XOFLUZA	BALOXAVIR MARBOXIL	Oct 2039
XOFLUZA	BALOXAVIR MARBOXIL	Apr 2041

Catalogue

Marketed products

Showing 93 of 93.

Brand	Generic name	Form	Category
ACTEMRA	tocilizumab	INJECTION, SOLUTION, CONCENTRATE	BLA
ACTEMRA	tocilizumab	INJECTION, SOLUTION, CONCENTRATE	BLA
ACTEMRA	tocilizumab	INJECTION, SOLUTION, CONCENTRATE	BLA
ALECENSA	ALECTINIB HYDROCHLORIDE	CAPSULE	NDA
Actemra	tocilizumab	INJECTION, SOLUTION	BLA
Actemra ACTPen	tocilizumab	INJECTION, SOLUTION	BLA
Activase	Alteplase	KIT	BLA
Activase	Alteplase	KIT	BLA
-	Astegolimab	LIQUID	DRUG FOR FURTHER PROCESSING
Avastin	bevacizumab	INJECTION, SOLUTION	BLA
Avastin	bevacizumab	INJECTION, SOLUTION	BLA
Cathflo Activase	Alteplase	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
CellCept	Mycophenolate Mofetil	CAPSULE	NDA
CellCept	Mycophenolate Mofetil	TABLET, FILM COATED	NDA
CellCept	Mycophenolate Mofetil	POWDER, FOR SUSPENSION	NDA
CellCept	Mycophenolate Mofetil hydrochloride	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	NDA
Columvi	Glofitamab	SOLUTION, CONCENTRATE	BLA
Columvi	Glofitamab	CONCENTRATE	BLA
Cotellic	COBIMETINIB	TABLET, FILM COATED	NDA
ERIVEDGE	vismodegib	CAPSULE	NDA
ESBRIET	PIRFENIDONE	TABLET, COATED	NDA
ESBRIET	PIRFENIDONE	TABLET, COATED	NDA
EVRYSDI	Risdiplam	POWDER, FOR SOLUTION	NDA
EVRYSDI	Risdiplam	TABLET	NDA
Enspryng	Satralizumab	INJECTION, SOLUTION	BLA
Gavreto	Pralsetinib	CAPSULE	NDA
Gazyva	obinutuzumab	INJECTION, SOLUTION, CONCENTRATE	BLA
Hemlibra	emicizumab	INJECTION, SOLUTION	BLA
Hemlibra	emicizumab	INJECTION, SOLUTION	BLA
Hemlibra	emicizumab	INJECTION, SOLUTION	BLA
Hemlibra	emicizumab	INJECTION, SOLUTION	BLA
Hemlibra	emicizumab	INJECTION, SOLUTION	BLA
Hemlibra	emicizumab	INJECTION, SOLUTION	BLA
Herceptin	Trastuzumab	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Herceptin Hylecta	Trastuzumab and hyaluronidase-oysk	INJECTION, SOLUTION	BLA
Itovebi	Inavolisib	TABLET, FILM COATED	NDA
Itovebi	Inavolisib	TABLET, FILM COATED	NDA
KADCYLA	ADO-TRASTUZUMAB EMTANSINE	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
KADCYLA	ADO-TRASTUZUMAB EMTANSINE	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
LUCENTIS	RANIBIZUMAB	INJECTION, SOLUTION	BLA
LUCENTIS	RANIBIZUMAB	INJECTION, SOLUTION	BLA
Lunsumio	Mosunetuzumab	CONCENTRATE	BLA
Lunsumio	Mosunetuzumab	CONCENTRATE	BLA
Lunsumio Velo	Mosunetuzumab	INJECTION	BLA
Lunsumio Velo	Mosunetuzumab	INJECTION	BLA
-	Mosunetuzumab	LIQUID	DRUG FOR FURTHER PROCESSING
-	Mosunetuzumab	LIQUID	DRUG FOR FURTHER PROCESSING
OCREVUS	ocrelizumab	INJECTION	BLA
Ocrevus Zunovo	ocrelizumab and hyaluronidase	INJECTION, SOLUTION	BLA
-	Omalizumab	LIQUID	DRUG FOR FURTHER PROCESSING
PERJETA	Pertuzumab	INJECTION, SOLUTION, CONCENTRATE	BLA
POLIVY	polatuzumab vedotin	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
POLIVY	polatuzumab vedotin	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	INJECTION, SOLUTION	BLA
Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	INJECTION, SOLUTION	BLA
Piasky	Crovalimab	INJECTION, SOLUTION	BLA
-	Polatuzumab vedotin	LIQUID	DRUG FOR FURTHER PROCESSING
Pulmozyme	dornase alfa	SOLUTION	BLA
-	RANIBIZUMAB	SOLUTION	DRUG FOR FURTHER PROCESSING
Rituxan	rituximab	INJECTION, SOLUTION	BLA
Rituxan	rituximab	INJECTION, SOLUTION	BLA
Rituxan Hycela	rituximab and hyaluronidase	INJECTION, SOLUTION	BLA
Rituxan Hycela	rituximab and hyaluronidase	INJECTION, SOLUTION	BLA
Rozlytrek	ENTRECTINIB	CAPSULE	NDA
Rozlytrek	ENTRECTINIB	CAPSULE	NDA
Rozlytrek	ENTRECTINIB	PELLET	NDA
Susvimo	Ranibizumab	INJECTION, SOLUTION	BLA
TECENTRIQ	atezolizumab	INJECTION, SOLUTION	BLA
TECENTRIQ	atezolizumab	INJECTION, SOLUTION	BLA
TNKase	tenecteplase	KIT	BLA
TNKase	tenecteplase	KIT	BLA
TNKase	tenecteplase	KIT	BLA
Tamiflu	oseltamivir phosphate	CAPSULE	NDA
Tamiflu	oseltamivir phosphate	CAPSULE	NDA
Tamiflu	Oseltamivir Phosphate	POWDER, FOR SUSPENSION	NDA
Tecentriq Hybreza	atezolizumab and hyaluronidase-tqjs	INJECTION	BLA
-	Tocilizumab	LIQUID	DRUG FOR FURTHER PROCESSING
VABYSMO	Faricimab	INJECTION, SOLUTION	BLA
XOLAIR	omalizumab	INJECTION, SOLUTION	BLA
Xofluza	BALOXAVIR MARBOXIL	GRANULE, FOR SOLUTION	NDA
Xofluza	Baloxavir Marboxil	GRANULE, FOR SUSPENSION	NDA
Xofluza	Baloxavir Marboxil	GRANULE, FOR SUSPENSION	NDA
Xofluza	BALOXAVIR MARBOXIL	TABLET, FILM COATED	NDA
Xofluza	BALOXAVIR MARBOXIL	TABLET, FILM COATED	NDA
Xolair	omalizumab	INJECTION, SOLUTION	BLA
Xolair PFS	omalizumab	INJECTION, SOLUTION	BLA
Xolair PFS	omalizumab	INJECTION, SOLUTION	BLA
ZELBORAF	Vemurafenib	TABLET, FILM COATED	NDA
-	bevacizumab	LIQUID	DRUG FOR FURTHER PROCESSING
-	dornase alfa	LIQUID	DRUG FOR FURTHER PROCESSING
-	pertuzumab	SOLUTION	DRUG FOR FURTHER PROCESSING
-	rituximab	LIQUID	DRUG FOR FURTHER PROCESSING
-	somatropin	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.