Ustekinumab - Biologic Drug Details

Summary for Ustekinumab

Tradenames:	1
High Confidence Patents:	95
Applicants:	9
BLAs:	12
Suppliers: see list	12
Recent Clinical Trials:	See clinical trials for Ustekinumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Ustekinumab

Recent Clinical Trials for Ustekinumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
Xian-Janssen Pharmaceutical Ltd.	PHASE4
University of California, San Francisco	PHASE4

See all Ustekinumab clinical trials

Recent Litigation for Ustekinumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
MHL Custom, Inc. v. Waydoo USA, Inc.	2021-01-27
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31
Cordis Corporation v. Advanced Cardio Sys	1997-10-03

See all Ustekinumab litigation

Pharmacology for Ustekinumab

Mechanism of Action	Interleukin-12 Antagonists Interleukin-23 Antagonists
Established Pharmacologic Class	Interleukin-12 Antagonist Interleukin-23 Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for Ustekinumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for Ustekinumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,065,007	2031-03-18	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,099,039	2036-11-17	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,155,018	2037-07-06	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,232,014	2037-06-05	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,266,597	2037-07-24	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,316,091	2038-06-29	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,370,440	2035-04-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for Ustekinumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,016,338	2036-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,105,354	2037-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,111,968	2036-08-10	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,172,841	2037-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,184,001	2036-06-02	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,261,083	2034-01-03	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,265,291	2037-02-13	Patent claims search

International Patents for Ustekinumab

Country	Patent Number	Estimated Expiration
China	103608062
European Patent Office	2686050
World Intellectual Property Organization (WIPO)	2012128674
Canada	2649422
European Patent Office	2015817
Spain	2456065
Japan	2009534093

Supplementary Protection Certificates for Ustekinumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2018/018	Ireland		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: EU/1/17/1234 20171114
132018000000261	Italy		PRODUCT NAME: GUSELKUMAB(TREMFYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1234, 20171114
2018C/019	Belgium		PRODUCT NAME: GUSELKUMAB; AUTHORISATION NUMBER AND DATE: EU/1/17/1234 20171114
329 12-2018	Slovakia		PRODUCT NAME: GUSELKUMAB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1234 20171114
CA 2018 00016	Denmark		PRODUCT NAME: ET ANTISTOF OMFATTENDE EN AMINOSYRESEKVENS FOR LET KAEDES KOMPLEMENTARITETSBESTEMMENDE REGION 1 (CDRL1) MED SEQ ID NO:50; EN CDRL2-AMINOSYRESEKVENS MED SEQ ID NO:56 OG CDRL3-AMINOSYRESEKVENS MED SEQ ID NO:73; OG...; REG. NO/DATE: EU/1/17/1234 20171114
201840014	Slovenia		PRODUCT NAME: GUSELKUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1234; DATE OF NATIONAL AUTHORISATION: 20171110; AUTHORITY FOR NATIONAL AUTHORISATION: EU
C01971366/01	Switzerland		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66583 13.06.2018