PRALUENT Drug Profile

Summary for Tradename: PRALUENT

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PRALUENT
Recent Clinical Trials:	See clinical trials for PRALUENT

See drug prices for PRALUENT

Recent Clinical Trials for PRALUENT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sun U. Kwon	Phase 4
Jonathan Sevransky	Phase 1
Chang Gung Memorial Hospital	Phase 2

See all PRALUENT clinical trials

Pharmacology for PRALUENT

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 PRALUENT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for PRALUENT 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
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,023,654	2036-12-13	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,058,630	2032-10-22	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,154,813	2037-07-03	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,253,102	2035-10-12	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,337,070	2037-01-12	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,369,114	2033-03-14	Patent claims search
Regeneron Pharmaceuticals, Inc.	PRALUENT	alirocumab	Injection	125559	10,472,424	2034-09-23	Patent claims search