Pembrolizumab - Biologic Drug Details

Summary for pembrolizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for pembrolizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pembrolizumab

Recent Clinical Trials for pembrolizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2/Phase 3
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
James Isaacs, MD	Phase 1

See all pembrolizumab clinical trials

Recent Litigation for pembrolizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.	2022-03-17

See all pembrolizumab litigation

PTAB Litigation

Petitioner	Date
Genome & Company	2018-10-02

See all pembrolizumab litigation

Pharmacology for pembrolizumab

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody

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 pembrolizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514			Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2028-06-13	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2032-12-19	Company disclosures

3) Low Certainty: US Patents for pembrolizumab 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
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-06-26	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-02-06	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-10-30	Patent claims search