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
University of California, San Diego	Phase 4
Howard University	Phase 4
University of Alabama at Birmingham	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	6,667,041	2017-07-15	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	6,683,049	2013-12-28	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	6,896,886	2013-12-28	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	6,974,578	2013-12-28	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	7,001,602	2017-07-15	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	7,429,387	2017-07-15	Company disclosures
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	7,449,192	2017-07-15	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	10,016,338	2033-03-11	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	10,039,910	2039-02-26	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	10,149,893	2039-02-26	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	10,206,743	2034-03-16	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	10,226,550	2036-03-11	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	10,286,159	2039-05-16	Patent claims search
Abbvie Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	10,300,121	2035-12-21	Patent claims search

International Patents for onabotulinumtoxina

Country	Patent Number	Estimated Expiration
Japan	2006160755
European Patent Office	1725253
World Intellectual Property Organization (WIPO)	9903483
Spain	2354166
Portugal	1949909
Spain	2159624
Spain	2332905

Supplementary Protection Certificates for onabotulinumtoxina

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122013000060	Germany		PRODUCT NAME: BOTULINUMTOXIN; NAT. REGISTRATION NO/DATE: IE/H/0113/001-003/II/077 20130131; FIRST REGISTRATION: FINNLAND IE/H/0113/001-003/II/077-FI 20130116
122008000043	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
132013902177250	Italy		PRODUCT NAME: TOSSINA BOTULINICA DI TIPO A(BOTOX); AUTHORISATION NUMBER(S) AND DATE(S): NL25449, 20110826;034883013/M, 20130123
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
CA 2013 00041	Denmark
300654	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
122012000065	Germany		PRODUCT NAME: BOTULINUMTOXIN; NAT. REGISTRATION NO/DATE: 55006.00.00 74281.00.00 80457.00.00 20110920 FIRST REGISTRATION: FRANKREICH NL 25449 NL 32017 NL 32018 20110822