Evolocumab - Biologic Drug Details

Summary for evolocumab

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

Recent Clinical Trials for evolocumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1
Amgen	Early Phase 1
University of Pennsylvania	Early Phase 1

See all evolocumab clinical trials

Recent Litigation for evolocumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Baxalta Incorporated v. Genentech, Inc.	2022-02-10
Amgen Inc. v. Sanofi	2017-01-11
Amgen Inc. v. Sanofi	2014-11-16

See all evolocumab litigation

Pharmacology for evolocumab

Mechanism of Action	PCSK9 Inhibitors
Established Pharmacologic Class	PCSK9 Inhibitor
Chemical Structure	Antibodies, Monoclonal

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. 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.

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 evolocumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	REPATHA	evolocumab	Injection	125522	8,030,457	2027-08-23	Company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522	8,563,698	2027-08-23	Company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522	8,829,165	2027-08-23	Company disclosures

3) Low Certainty: US Patents for evolocumab 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
Amgen Inc.	REPATHA	evolocumab	Injection	125522	10,058,630	2032-10-22	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522	10,154,813	2037-07-03	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522	10,253,102	2035-10-12	Patent claims search

International Patents for evolocumab

Country	Patent Number	Estimated Expiration
Mexico	2020008898
Taiwan	201716444
Australia	2013203685

Supplementary Protection Certificates for evolocumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2016 00027	Denmark		PRODUCT NAME: EVOLOCUMAB; REG. NO/DATE: EU/1/15/1016 20150721
122016000059	Germany		PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150923
93180	Luxembourg		PRODUCT NAME: ALIROCUMAB OU UN DERIVE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PRALUENT); FIRST REGISTRATION DATE: 20150923