LOTILANER - Generic Drug Details

What are the generic sources for lotilaner and what is the scope of freedom to operate?

Lotilaner is the generic ingredient in one branded drug marketed by Tarsus and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lotilaner has forty-three patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for LOTILANER

International Patents:	43
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	3
Patent Applications:	840
DailyMed Link:	LOTILANER at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LOTILANER

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LOTILANER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
LianBio LLC	Phase 3
Tarsus Pharmaceuticals, Inc.	Phase 2

See all LOTILANER clinical trials

Pharmacology for LOTILANER

Drug Class

Ectoparasiticide

US Patents and Regulatory Information for LOTILANER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes			Y
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for LOTILANER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Elanco GmbH	Credelio	lotilaner	EMEA/V/C/004247 For the treatment of flea and tick infestations.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).DogsThis veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).CatsThis veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).	Authorised	no	no	no	2017-04-23

International Patents for LOTILANER

Country	Patent Number	Title	Estimated Expiration
Denmark	2379537
Canada	2747354	COMPOSES ORGANIQUES (ORGANIC COMPOUNDS)
World Intellectual Property Organization (WIPO)	2010070068
Spain	2395704
Israel	307992	פורמולציות קוטלות טפילים המכילות איזוקסאזולין ושיטות לטיפול בדלקת עפעפיים (Isoxazoline parasiticide formulations and methodsfor treating blepharitis)

Supplementary Protection Certificates for LOTILANER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379537	C02379537/01	Switzerland		PFANDNEHMER/IN: GOLDMAN SACHS BANK USA, 200 WEST STREET, NEW YORK, NY 10282, US
2379537	132017000099235	Italy		PRODUCT NAME: LOTILANER(CREDELIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/2/17/206, 20170427
2379537	699	Finland
2379537	CR 2017 00034	Denmark		PRODUCT NAME: LOTILANER OG SALTE DERAF; REG. NO/DATE: EU/2/17/206/001-015 20170427
2379537	2017048	Norway		PRODUCT NAME: LOTILANER; REG. NO/DATE: EU/2/17/206 20170523