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XDEMVY Drug Patent Profile

When do Xdemvy patents expire, and what generic alternatives are available?

Xdemvy is a drug marketed by Tarsus and is included in one NDA. There are six patents protecting this drug.

This drug has forty-two patent family members in twenty-five countries.

The generic ingredient in XDEMVY is lotilaner. One supplier is listed for this compound. Additional details are available on the lotilaner profile page.

DrugPatentWatch^® Generic Entry Outlook for Xdemvy

Xdemvy will be eligible for patent challenges on July 24, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 24, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XDEMVY

International Patents:	42
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for XDEMVY
What excipients (inactive ingredients) are in XDEMVY?	XDEMVY excipients list
DailyMed Link:	XDEMVY at DailyMed

See drug prices for XDEMVY

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217603

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.

US Patents and Regulatory Information for XDEMVY

XDEMVY is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XDEMVY

FDA Regulatory Exclusivity protecting XDEMVY

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
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 XDEMVY

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 XDEMVY

When does loss-of-exclusivity occur for XDEMVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Denmark

European Patent Office

Hungary

Japan

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

South Africa

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XDEMVY around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3723739	PRÉPARATIONS DE PARASITICIDES À BASE D'ISOXAZOLINE ET MÉTHODES DE TRAITEMENT DE LA BLÉPHARITE (ISOXAZOLINE PARASITICIDE FORMULATIONS AND METHODS FOR TREATING BLEPHARITIS)
Mexico	2011006568	COMPUESTOS ORGANICOS. (ISOXAZOLINE DERIVATIVES AND THEIR USE AS PESTICIDE.)
Mexico	2020006309	FÓRMULACIONES DE PARASITICIDA DE ISOXAZOLINA Y MÉTODOS PARA EL TRATAMIENTO DE LA BLEFARITIS. (ISOXAZOLINE PARASITICIDE FORMULATIONS AND METHODS FOR TREATING BLEPHARITIS.)
China	111655241	用于治疗睑炎的异恶唑啉驱虫剂制剂和方法 (Isoxazoline parasiticide formulations and methods for treating blepharitis)
Denmark	2379537

Supplementary Protection Certificates for XDEMVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379537	2017C/029	Belgium		PRODUCT NAME: CREDELIO - LOTINALER; AUTHORISATION NUMBER AND DATE: EU/2/17/206 20170427
2379537	SPC/GB17/052	United Kingdom		PRODUCT NAME: LOTILANER AND SALTS THEREOF; REGISTERED: UK EU/2/17/206/001 (NI) 20170427; UK EU/2/17/206/002 (NI) 20170427; UK EU/2/17/206/003 (NI) 20170427; UK EU/2/17/206/004 (NI) 20170427; UK EU/2/17/206/005 (NI) 20170427; UK EU/2/17/206/006 (NI) 20170427; UK VM 52127/5008 (GB) 20170427; UK VM 52127/5009 (GB) 20170427; UK VM 52127/5010 (GB) 20170427; UK EU/2/17/206/013 (NI) 20170427; UK EU/2/17/206/014 (NI) 20170427; UK EU/2/17/206/015 (NI) 20170427; UK VM 52127/5004 (GB) 20170427; UK VM 52127/5006 (GB) 20170427; UK VM 52127/5007 (GB) 20170427; UK EU/2/17/206/007 (NI) 20170427; UK EU/2/17/206/008 (NI) 20170427; UK EU/2/17/206/009 (NI) 20170427; UK EU/2/17/206/010 (NI) 20170427; UK EU/2/17/
2379537	122017000053	Germany		PRODUCT NAME: LOTILANER; REGISTRATION NO/DATE: EU/2/17/206 20170425
2379537	2017/037	Ireland		PRODUCT NAME: LOTILANER AND SALTS THEREOF.; REGISTRATION NO/DATE: EU/2/17/206 20170425
2379537	699	Finland