Natalizumab - Biologic Drug Details

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Summary for natalizumab

Tradenames:	1
High Confidence Patents:	6
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for natalizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for natalizumab

Recent Clinical Trials for natalizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Washington University School of Medicine	Phase 1
BioLineRx, Ltd.	Phase 1
Queen Mary University of London	Phase 2

See all natalizumab clinical trials

Recent Litigation for natalizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all natalizumab litigation

PTAB Litigation

Petitioner	Date
Miltenyi Biomedicine GmbH et al.	2022-04-12
Swiss Pharma International AG	2016-04-18
Swiss Pharma International AG et al.	2016-04-18

See all natalizumab litigation

Pharmacology for natalizumab

Mechanism of Action	Integrin Receptor Antagonists
Established Pharmacologic Class	Integrin Receptor 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:

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.

General 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.

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 natalizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for natalizumab Derived from Company Disclosures

These patents were obtained from company disclosures

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	⤷ Sign Up	2009-12-01	Company disclosures
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	⤷ Sign Up	2005-01-30	Company disclosures
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	⤷ Sign Up	2015-03-24	Company disclosures
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	⤷ Sign Up	2014-01-25	Company disclosures
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Patent No.	>Estimated Patent Expiration	>Source

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

These patents were obtained by searching patent claims