Onabotulinumtoxina - Biologic Drug Details

Summary for onabotulinumtoxina

Tradenames:	2
High Confidence Patents:	11
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for onabotulinumtoxina
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for onabotulinumtoxina

Recent Clinical Trials for onabotulinumtoxina

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Brown University	Phase 4
University of New Mexico	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4

See all onabotulinumtoxina clinical trials

Recent Litigation for onabotulinumtoxina

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Grant Prideco, Inc. v. Schlumberger Technology Corporation	2023-02-27
Teva Pharmaceuticals International GmbH v. Eli Lilly and Company	2021-06-07

See all onabotulinumtoxina litigation

PTAB Litigation

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

See all onabotulinumtoxina litigation

Pharmacology for onabotulinumtoxina

Mechanism of Action	Acetylcholine Release Inhibitors
Physiological Effect	Neuromuscular Blockade
Established Pharmacologic Class	Acetylcholine Release Inhibitor Neuromuscular Blocker

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 onabotulinumtoxina Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

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

3) Low Certainty: US Patents for onabotulinumtoxina 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
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2033-03-11	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2039-02-26	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000		2034-03-16	Patent claims search

International Patents for onabotulinumtoxina

Country	Patent Number	Estimated Expiration
South Korea	20010021941
European Patent Office	1421948
South Korea	101786040
Germany	122008000043

Supplementary Protection Certificates for onabotulinumtoxina

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132013902177250	Italy		PRODUCT NAME: TOSSINA BOTULINICA DI TIPO A(BOTOX); AUTHORISATION NUMBER(S) AND DATE(S): NL25449, 20110826;034883013/M, 20130123
92250	Luxembourg		PRODUCT NAME: TOXINE BOTULIQUE DE TYPE A DE CLOSTRIDIUM BOTULINUM
SPC/GB12/053	United Kingdom		CORRECTED ENTRY FOLLOWS; REASON FOR LAPSE IN JOURNAL 6768 - 06.02.2019 WAS PUBLISHED IN ERROR, THE REASON FOR LAPSE WAS FEES NOT PAID. ; APPLICANT: ALLERGAN, INC.; 2525 DUPONT DRIVE, IRVINE, CALIFORNIA 92612, UNITED STATES OF AMERICA; PRODUCT: BOTULINUM TOXIN; PRODUCT TYPE: MEDICINAL; AUTHORISED: UK PL 00426/0074-0110 24 SEPTEMBER 2012; UK PL 00426/0118-0030 24 SEPTEMBER 2012; UK PL 00426/0119-0012 24 SEPTEMBER 2012; AUTHORISED EXTENSION:; PATENT NO: EP1658858; TITLE: USE OF BOTULINUM TOXIN FOR THE TREATMENT OF RECALCITRANT VOIDING DYSFUNCTION.; SPC NO: SPC/GB12/053; REASON FOR LAPSE: SURRENDERED; DATE LAPSED: 15 JANUARY 2019
CR 2013 00041	Denmark		PRODUCT NAME: BOTULINUM TOXIN, HERUNDER BOTULINUM TOXIN A; NAT. REG. NO/DATE: 43623, 31350, 46039 (DK) 20130219; FIRST REG. NO/DATE: FI 25162,15424, 28146 20130116