Register entryShortage reported

Janssen Pharmaceuticals, Inc.

Data as of · How to read this entry

Registered sites
0
Active NDC listings
149
Labeller names
9
Live patents
234
Exclusivities
10
Shortage listings
8
Countries
0
Alert

Drug shortage listings

8
DrugPresentationStatusAvailabilityPosted / updated
Methylphenidate Hydrochloride Tablet, Extended ReleasePsychiatryConcerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01)CurrentAvailable26 Jul 202317 Sept 2026
Methylphenidate Hydrochloride Tablet, Extended ReleasePsychiatryConcerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01)CurrentAvailable26 Jul 202317 Sept 2026
Methylphenidate Hydrochloride Tablet, Extended ReleasePsychiatryConcerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01)CurrentAvailable26 Jul 202317 Sept 2026
Methylphenidate Hydrochloride Tablet, Extended ReleasePsychiatryConcerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01)CurrentAvailable26 Jul 202317 Sept 2026
Rivaroxaban For SuspensionHematologyXarelto, For Suspension, 155 mg (NDC 50458-575-01)To Be Discontinued-18 Sept 202618 Sept 2026
Itraconazole CapsuleAnti-Infective, OtherSporanox, Capsule, 100 mg (NDC 50458-290-01)To Be Discontinued-27 Feb 202627 Feb 2026
Itraconazole CapsuleAnti-Infective, OtherSporanox, Capsule, 100 mg (NDC 10147-1700-3)To Be Discontinued-27 Feb 202627 Feb 2026
Itraconazole CapsuleAnti-Infective, OtherSporanox, Capsule, 100 mg (NDC 50458-290-04)To Be Discontinued-27 Feb 202627 Feb 2026
Catalogue

Drug listings by form and route

149

149 active NDC listings: 130 human prescription drug, 15 bulk ingredient, 3 drug for further processing, 1 cellular therapy. By marketing category: NDA 95, BLA 36, BULK INGREDIENT 15, DRUG FOR FURTHER PROCESSING 3.

Dosage formNDCs
tablet, film coated30
injection20
powder15
injection, solution13
tablet11
solution9
tablet, extended release8
injection, suspension, extended release6
kit6
tablet, orally disintegrating5
injection, solution, concentrate4
tablet, coated4
tablet, film coated, extended release4
injection, powder, lyophilized, for solution3
capsule, coated pellets2
RouteNDCs
oral73
subcutaneous24
intravenous20
intramuscular13
intravesical1
nasal1
Labeller name on the listingNDCs
janssen pharmaceuticals, inc.57
janssen biotech, inc.36
janssen products, lp17
janssen pharmaceutica nv16
janssen products lp12
janssen pharmaceuticals, inc8
janssen biotech, inc1
janssen pharmaceutica, nv1
janssen pharmaceutical nv1
Exclusivity

Patents and exclusivities

234
PatentProductCoversExpiry
7700645PREZCOBIX, PREZISTA, SYMTUZAcobicistat; darunavir ethanolate; cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate; darunavirsubstance, productDec 2026
9592207SPRAVATOesketamine hydrochlorideuseMar 2027
8802689ERLEADAapalutamideuseMar 2027
9388159ERLEADAapalutamidesubstance, productMar 2027
9987261ERLEADAapalutamideproductMar 2027
7700645*PEDPREZCOBIX, PREZISTAcobicistat; darunavir ethanolate; darunaviruseJun 2027
7943788INVOKAMET, INVOKAMET XR, INVOKANAcanagliflozin; canagliflozin; metformin hydrochloridesubstance, productJul 2027
8071579AKEEGAabiraterone acetate; niraparib tosylateuseAug 2027
8143241AKEEGAabiraterone acetate; niraparib tosylateuseAug 2027
8513202INVOKAMET, INVOKAMET XR, INVOKANAcanagliflozin; canagliflozin; metformin hydrochloridesubstance, productDec 2027
8895557YONDELIStrabectedinproductJan 2028
7943788*PEDINVOKAMET, INVOKAMET XR, INVOKANAcanagliflozin; canagliflozin; metformin hydrochlorideuseJan 2028
8513202*PEDINVOKAMET, INVOKAMET XR, INVOKANAcanagliflozin; canagliflozin; metformin hydrochlorideuseJun 2028
8895557*PEDYONDELIStrabectedinuseJul 2028
7943582INVOKAMET, INVOKAMET XR, INVOKANAcanagliflozin; canagliflozin; metformin hydrochloridesubstance, productFeb 2029
8436185AKEEGAabiraterone acetate; niraparib tosylatesubstance, productApr 2029
7943582*PEDINVOKAMET, INVOKAMET XR, INVOKANAcanagliflozin; canagliflozin; metformin hydrochlorideuseAug 2029
8148374PREZCOBIX, SYMTUZAcobicistat; darunavir ethanolate; cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumaratesubstance, productSept 2029
8148399OLYSIOsimeprevir sodiumsubstance, productSept 2029
12403086INLEXZOgemcitabine hydrochlorideproductJun 2030
11576894INVOKAMETcanagliflozin; metformin hydrochlorideproductJul 2030
12576253INLEXZOgemcitabine hydrochlorideproductDec 2030
9439906INVEGA SUSTENNApaliperidone palmitateuseJan 2031
8071623AKEEGAabiraterone acetate; niraparib tosylatesubstance, productMar 2031
9464071BALVERSAerdafitinibuseApr 2031
8859562AKEEGAabiraterone acetate; niraparib tosylateuseAug 2031
8445507ERLEADAapalutamidesubstance, productFeb 2032
8679094INLEXZOgemcitabine hydrochlorideproductApr 2032
8754065SYMTUZAcobicistat; darunavir; emtricitabine; tenofovir alafenamide fumaratesubstance, productAug 2032
9296769SYMTUZAcobicistat; darunavir; emtricitabine; tenofovir alafenamide fumaratesubstance, productAug 2032
10039718PREZCOBIX, SYMTUZAcobicistat; darunavir ethanolate; cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarateproductOct 2032
8785500SPRAVATOesketamine hydrochlorideuseMar 2033
8895601BALVERSAerdafitinibsubstance, productApr 2033
9481663ERLEADAapalutamidesubstance, productJun 2033
10849888ERLEADAapalutamideuseSept 2033
9884054ERLEADAapalutamideuseSept 2033
RE49353ERLEADAapalutamideuseSept 2033
RE50642ERLEADAapalutamideuseSept 2033
9539218XARELTOrivaroxabanuseFeb 2034
11446260SPRAVATOesketamine hydrochlorideuseMar 2034
9539218*PEDXARELTOrivaroxabanuseAug 2034
10729823INLEXZOgemcitabine hydrochlorideproductAug 2034
12447241INLEXZOgemcitabine hydrochlorideproductAug 2034
9902714BALVERSAerdafitinibproductMar 2035
10869844SPRAVATOesketamine hydrochlorideuseSept 2035
11173134SPRAVATOesketamine hydrochlorideuseSept 2035
11311500SPRAVATOesketamine hydrochlorideuseSept 2035
9593098LAZCLUZElazertinib mesylatesubstance, productOct 2035
RE50528LAZCLUZElazertinib mesylatesubstance, productOct 2035
12037644BALVERSAerdafitinibuseOct 2035
12303493ERLEADAapalutamideproductDec 2035
10898482BALVERSAerdafitinibproductFeb 2036
11684620BALVERSAerdafitinibuseFeb 2036
10143693INVEGA TRINZApaliperidone palmitateuseApr 2036
12678498BALVERSAerdafitinibuseJun 2036
10478494BALVERSAerdafitinibuseAug 2036
11207311AKEEGAabiraterone acetate; niraparib tosylateuseJul 2037
11986468AKEEGAabiraterone acetate; niraparib tosylateuseJul 2037
11986469AKEEGAabiraterone acetate; niraparib tosylateuseJul 2037
11986470AKEEGAabiraterone acetate; niraparib tosylateuseJul 2037
ProductExclusivityUntil
AKEEGAABIRATERONE ACETATE; NIRAPARIB TOSYLATEI-980 New indicationDec 2028
BALVERSAERDAFITINIBI-930 New indicationJan 2027
EDURANT PEDRILPIVIRINE HYDROCHLORIDEPED PaediatricSept 2027
ICOTYDEICOTROKINRA HYDROCHLORIDENCE New chemical entityMar 2031
INLEXZOGEMCITABINE HYDROCHLORIDENP New productSept 2028
INVOKAMETCANAGLIFLOZIN; METFORMIN HYDROCHLORIDEPED PaediatricJun 2028
INVOKAMET XRCANAGLIFLOZIN; METFORMIN HYDROCHLORIDEPED PaediatricJun 2028
INVOKANACANAGLIFLOZINPED PaediatricJun 2028
LAZCLUZELAZERTINIB MESYLATENCE New chemical entityAug 2029
SPRAVATOESKETAMINE HYDROCHLORIDEI-959 New indicationJan 2028
Catalogue

Marketed products

149
BrandGeneric nameForm / routeNDC
AKEEGANIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATEtablet, film coated, oral57894-050NDA
AKEEGANIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATEtablet, film coated, oral57894-100NDA
-Abiraterone Acetatepowder12578-619BULK INGREDIENT
-Apalutamidepowder12578-621BULK INGREDIENT
BALVERSAErdafitinibtablet, film coated, oral59676-030NDA
BALVERSAErdafitinibtablet, film coated, oral59676-040NDA
BALVERSAErdafitinibtablet, film coated, oral59676-050NDA
-Buprenorphinepowder12578-607BULK INGREDIENT
-Buprenorphine Hydrochloridepowder12578-608BULK INGREDIENT
CARVYKTIciltacabtagene autoleucelinjection, suspension, intravenous57894-111BLA
CONCERTAMethylphenidate hydrochloridetablet, extended release, oral50458-585NDA
CONCERTAMethylphenidate hydrochloridetablet, extended release, oral50458-586NDA
CONCERTAMethylphenidate hydrochloridetablet, extended release, oral50458-587NDA
CONCERTAMethylphenidate hydrochloridetablet, extended release, oral50458-588NDA
-Canagliflozinpowder12578-611BULK INGREDIENT
-Canagliflozinpowder12578-615BULK INGREDIENT
DARZALEXDaratumumabinjection, solution, concentrate, intravenous57894-502BLA
Darzalex Fasprodaratumumab and hyaluronidase-fihj (human recombinant)injection, subcutaneous57894-503BLA
Darzalex IVDaratumumabinjection, solution, concentrate, intravenous57894-505BLA
EDURANTrilpivirine hydrochloridetablet, film coated, oral59676-278NDA
EDURANT PEDrilpivirine hydrochloridetablet, for suspension, oral59676-280NDA
ELMIRONPENTOSAN POLYSULFATE SODIUMcapsule, gelatin coated, oral50458-098NDA
ERLEADAApalutamidetablet, film coated, oral59676-600NDA
ERLEADAApalutamidetablet, film coated, oral59676-604NDA
-Galantamine hydrobromidepowder12578-890BULK INGREDIENT
Haldol DecanoateHaloperidol Decanoateinjection, intramuscular50458-253NDA
Haldol DecanoateHaloperidol Decanoateinjection, intramuscular50458-254NDA
-Haloperidolpowder12578-617BULK INGREDIENT
ICOTYDEicotrokinratablet, film coated, oral57894-201NDA
IMAAVYnipocalimab-aahuinjection, solution, concentrate, intravenous57894-800BLA
IMAAVYnipocalimab-aahuinjection, solution, concentrate, intravenous57894-801BLA
INFLIXIMABINFLIXIMABinjection, powder, lyophilized, for solution, intravenous57894-160BLA
INLEXZOgemcitabine intravesicalsystem, intravesical57894-225NDA
INVEGApaliperidonetablet, extended release, oral50458-550NDA
INVEGApaliperidonetablet, extended release, oral50458-551NDA
INVEGApaliperidonetablet, extended release, oral50458-552NDA
INVEGApaliperidonetablet, extended release, oral50458-554NDA
INVEGA HAFYERApaliperidone palmitateinjection, suspension, extended release, intramuscular50458-611NDA
INVEGA HAFYERApaliperidone palmitateinjection, suspension, extended release, intramuscular50458-612NDA
INVEGA SUSTENNApaliperidone palmitateinjection, intramuscular50458-560NDA
INVEGA SUSTENNApaliperidone palmitateinjection, intramuscular50458-561NDA
INVEGA SUSTENNApaliperidone palmitateinjection, intramuscular50458-562NDA
INVEGA SUSTENNApaliperidone palmitateinjection, intramuscular50458-563NDA
INVEGA SUSTENNApaliperidone palmitateinjection, intramuscular50458-564NDA
INVEGA TRINZApaliperidone palmitateinjection, suspension, extended release, intramuscular50458-606NDA
INVEGA TRINZApaliperidone palmitateinjection, suspension, extended release, intramuscular50458-607NDA
INVEGA TRINZApaliperidone palmitateinjection, suspension, extended release, intramuscular50458-608NDA
INVEGA TRINZApaliperidone palmitateinjection, suspension, extended release, intramuscular50458-609NDA
INVOKAMETcanagliflozin and metformin hydrochloridetablet, film coated, oral50458-540NDA
INVOKAMETcanagliflozin and metformin hydrochloridetablet, film coated, oral50458-541NDA
INVOKAMETcanagliflozin and metformin hydrochloridetablet, film coated, oral50458-542NDA
INVOKAMETcanagliflozin and metformin hydrochloridetablet, film coated, oral50458-543NDA
INVOKAMET XRcanagliflozin and metformin hydrochloridetablet, film coated, extended release, oral50458-940NDA
INVOKAMET XRcanagliflozin and metformin hydrochloridetablet, film coated, extended release, oral50458-941NDA
INVOKAMET XRcanagliflozin and metformin hydrochloridetablet, film coated, extended release, oral50458-942NDA
INVOKAMET XRcanagliflozin and metformin hydrochloridetablet, film coated, extended release, oral50458-943NDA
INVOKANAcanagliflozintablet, film coated, oral50458-140NDA
INVOKANAcanagliflozintablet, film coated, oral50458-141NDA
-Icotrokinrapowder12578-623BULK INGREDIENT
Intelenceetravirinetablet, oral59676-570NDA
Intelenceetravirinetablet, oral59676-571NDA
Intelenceetravirinetablet, oral59676-572NDA
-Itraconazolepowder12578-299BULK INGREDIENT
LAZCLUZElazertinibtablet, film coated, oral57894-080NDA
LAZCLUZElazertinibtablet, film coated, oral57894-240NDA
-Loperamide hydrochloridepowder12578-409BULK INGREDIENT
-Mebendazolepowder12578-618BULK INGREDIENT
-Miconazole Nitratepowder12578-488BULK INGREDIENT
-POLYETHYLENE GLYCOL 400solution12578-115DRUG FOR FURTHER PROCESSING
-POLYETHYLENE GLYCOL 400solution12578-119DRUG FOR FURTHER PROCESSING
PONVORYPonesimodkit50458-707NDA
PONVORYPonesimodtablet, film coated, oral50458-720NDA
PREZCOBIXDARUNAVIR ETHANOLATE and COBICISTATtablet, film coated, oral59676-575NDA
PREZCOBIXDARUNAVIR ETHANOLATE and COBICISTATtablet, film coated, oral59676-578NDA
PREZCOBIX PEDDARUNAVIR ETHANOLATE and COBICISTATtablet, for suspension, oral59676-577NDA
PREZISTAdarunavirtablet, film coated, oral59676-562NDA
PREZISTAdarunavirtablet, film coated, oral59676-563NDA
PREZISTAdarunavirtablet, film coated, oral59676-564NDA
PREZISTAdarunavirsuspension, oral59676-565NDA
PREZISTAdarunavirtablet, film coated, oral59676-566NDA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-302BLA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-303BLA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-304BLA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-310BLA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-312BLA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-320BLA
PROCRITErythropoietininjection, solution, intravenous, subcutaneous59676-340BLA
-Polyethylene Glycol 400solution12578-117DRUG FOR FURTHER PROCESSING
REMICADEINFLIXIMABinjection, powder, lyophilized, for solution, intravenous57894-030BLA
RISPERDALrisperidonetablet, oral50458-300NDA
RISPERDALrisperidonetablet, oral50458-302NDA
RISPERDALrisperidonesolution, oral50458-305NDA
RISPERDALrisperidonetablet, oral50458-320NDA
RISPERDALrisperidonetablet, oral50458-330NDA
RISPERDALrisperidonetablet, oral50458-350NDA
RISPERDAL CONSTArisperidonekit50458-306NDA
RISPERDAL CONSTArisperidonekit50458-307NDA
RISPERDAL CONSTArisperidonekit50458-308NDA
RISPERDAL CONSTArisperidonekit50458-309NDA
RISPERDAL M-TABrisperidonetablet, orally disintegrating, oral50458-315NDA
RISPERDAL M-TABrisperidonetablet, orally disintegrating, oral50458-325NDA
RISPERDAL M-TABrisperidonetablet, orally disintegrating, oral50458-335NDA
RISPERDAL M-TABrisperidonetablet, orally disintegrating, oral50458-355NDA
RISPERDAL M-TABrisperidonetablet, orally disintegrating, oral50458-395NDA
-Rilpivirinepowder12578-622BULK INGREDIENT
-Risperidonepowder12578-303BULK INGREDIENT
Risperidonerisperidonesolution, oral50458-596NDA
Rybrevantamivantamab-vmjwinjection, intravenous57894-501BLA
Rybrevant FasproAMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)injection, subcutaneous57894-510BLA
Rybrevant FasproAMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)injection, subcutaneous57894-514BLA
Rybrevant FasproAMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)injection, subcutaneous57894-515BLA
Rybrevant FasproAMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)injection, subcutaneous57894-522BLA
SIMPONI ARIAgolimumabsolution, intravenous57894-350BLA
SIRTUROBedaquiline Fumaratetablet, oral59676-701NDA
SIRTUROBedaquiline Fumaratetablet, oral59676-702NDA
SPORANOXITRACONAZOLEcapsule, oral50458-290NDA
STELARAustekinumabinjection, solution, subcutaneous57894-060BLA
STELARAustekinumabinjection, solution, subcutaneous57894-061BLA
Simponigolimumabinjection, solution, subcutaneous57894-070BLA
Simponigolimumabinjection, solution, subcutaneous57894-071BLA
SpravatoEsketamine Hydrochloridesolution, nasal50458-028NDA
Stelaraustekinumabsolution, intravenous57894-054BLA
SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamidetablet, film coated, oral59676-800NDA
TALVEYtalquetamabinjection, subcutaneous57894-469BLA
TALVEYtalquetamabinjection, subcutaneous57894-470BLA
TECVAYLIteclistamab-cqyvinjection, subcutaneous57894-449BLA
TECVAYLIteclistamab-cqyvinjection, subcutaneous57894-450BLA
TREMFYAGuselkumabinjection, subcutaneous57894-640BLA
TREMFYAGuselkumabinjection, intravenous57894-650BLA
TREMFYAguselkumabinjection, subcutaneous57894-651BLA
Topamaxtopiramatetablet, coated, oral50458-639NDA
Topamaxtopiramatetablet, coated, oral50458-640NDA
Topamaxtopiramatetablet, coated, oral50458-641NDA
Topamaxtopiramatetablet, coated, oral50458-642NDA
Topamaxtopiramatecapsule, coated pellets, oral50458-645NDA
Topamaxtopiramatecapsule, coated pellets, oral50458-647NDA
VERMOXmebendazoletablet, chewable, oral50458-675NDA
XARELTOrivaroxabantablet, film coated, oral50458-577NDA
XARELTORivaroxabankit50458-584NDA
Xareltorivaroxabangranule, for suspension, oral50458-575NDA
Xareltorivaroxabantablet, film coated, oral50458-578NDA
Xareltorivaroxabantablet, film coated, oral50458-579NDA
Xareltorivaroxabantablet, film coated, oral50458-580NDA
YONDELISTrabectedininjection, powder, lyophilized, for solution, intravenous59676-610NDA
Zytigaabiraterone acetatetablet, oral57894-150NDA
ZytigaAbiraterone acetatetablet, film coated, oral57894-195NDA
ustekinumabustekinumabinjection, solution, subcutaneous57894-440BLA
ustekinumabustekinumabinjection, solution, subcutaneous57894-441BLA
ustekinumabustekinumabsolution, intravenous57894-444BLA
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Enquiry

Common questions

Is Janssen Pharmaceuticals, Inc. FDA approved?
Janssen Pharmaceuticals, Inc. holds no registered establishment of its own; 149 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Janssen Pharmaceuticals, Inc. make?
149 products are listed under Janssen Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film coated; injection; powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Janssen Pharmaceuticals, Inc. products in shortage?
4 presentations are currently listed in the FDA drug shortage database under Janssen Pharmaceuticals, Inc., covering Methylphenidate Hydrochloride Tablet, Extended Release.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.