Trastuzumab - Biologic Drug Details

Summary for trastuzumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	6
BLAs:	7
Suppliers: see list	7
Recent Clinical Trials:	See clinical trials for trastuzumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for trastuzumab

Recent Clinical Trials for trastuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Jeeyun Lee	Phase 1/Phase 2
MSD Sharp & Dohme GmbH, Germany	Phase 2
Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel	Phase 2

See all trastuzumab clinical trials

Recent Litigation for trastuzumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.	2023-11-17
Genentech, Inc. v. Biogen MA Inc.	2023-07-13
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all trastuzumab litigation

PTAB Litigation

Petitioner	Date
GEMoaB Monoclonals GmbH et al.	2019-12-20
	2018-04-24
	2018-03-20

See all trastuzumab litigation

Pharmacology for trastuzumab

Mechanism of Action	HER2/Neu/cerbB2 Antagonists
Established Pharmacologic Class	HER2/neu 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:

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 trastuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures