BOTOX Drug Profile

Summary for Tradename: BOTOX

Patents:	11
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for BOTOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BOTOX

See drug prices for BOTOX

Recent Litigation for BOTOX

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Teva Pharmaceuticals International GmbH v. Eli Lilly and Company	2021-06-07
In re: Aoki	2013-07-30

See all BOTOX litigation

PTAB Litigation

Petitioner	Date
Eli Lilly and Company	2022-04-11
	2017-02-21

See all BOTOX litigation

Pharmacology for BOTOX

Mechanism of Action	Acetylcholine Release Inhibitors
Established Pharmacologic Class	Acetylcholine Release Inhibitor

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 BOTOX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2017-07-15	Company disclosures
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2013-12-28	Company disclosures

3) Low Certainty: US Patents for BOTOX 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
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2033-03-11	Patent claims search
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search

International Patents for BOTOX

Country	Patent Number	Estimated Expiration
Japan	2002087986
New Zealand	602983
European Patent Office	1602379

Supplementary Protection Certificates for BOTOX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
509	Finland
92055	Luxembourg		PRODUCT NAME: TOXINE BOTULIQUE DE CLOSTRIDIUM BOTULINUM
2013C/047	Belgium		PRODUCT NAME: TOXINE BOTULIQUE TYPE A; AUTHORISATION NUMBER AND DATE: 263103-5/2012 20130128