Adalimumab - Biologic Drug Details

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Summary for adalimumab

Tradenames:	1
High Confidence Patents:	63
Applicants:	11
BLAs:	11
Suppliers: see list	19
Recent Clinical Trials:	See clinical trials for adalimumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adalimumab

Recent Clinical Trials for adalimumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda France	Phase 4
Teva takeda	Phase 4
University Medical Center Groningen	Phase 1/Phase 2

See all adalimumab clinical trials

Recent Litigation for adalimumab

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 adalimumab litigation

PTAB Litigation

Petitioner	Date
Fresenius Kabi USA, LLC et al.	2019-09-17
	2017-12-20
Sandoz Inc.	2017-11-06

See all adalimumab litigation

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 adalimumab Derived from Brand-Side Litigation

These patents were obtained from brand-side disclosures in response to biosimilar applications

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008	9,334,319	2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016	9,067,992	2023-07-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013	9,913,902	2027-04-04
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008	8,992,926	2022-05-06
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 28, 2017	9,181,337	2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015	9,522,953	2032-04-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016	9,359,434	2033-03-14
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Patent Expiration

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

No patents found based on company disclosures

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