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Last Updated: December 11, 2024

Lotilaner - Generic Drug Details


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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
Generic Entry 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

SponsorPhase
LianBio LLCPhase 3
Tarsus Pharmaceuticals, Inc.Phase 2

See all lotilaner clinical trials

Pharmacology for lotilaner
Drug ClassEctoparasiticide

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for lotilaner

Country Patent Number Title Estimated Expiration
Taiwan 201024289 Organic compounds ⤷  Sign Up
Portugal 2379537 ⤷  Sign Up
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) ⤷  Sign Up
Argentina 114474 COMPUESTOS DERIVADOS DE ISOOXAZOL SUSTITUIDOS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lotilaner

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379537 122017000053 Germany ⤷  Sign Up PRODUCT NAME: LOTILANER; REGISTRATION NO/DATE: EU/2/17/206 20170425
2379537 300891 Netherlands ⤷  Sign Up PRODUCT NAME: LOTILANER EN ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/2/17/206 20170427
2379537 40/2017 Austria ⤷  Sign Up PRODUCT NAME: LOTILANER UND SALZE DAVON; REGISTRATION NO/DATE: EU/2/17/206 (MITTEILUNG) 20170427
2379537 1790037-4 Sweden ⤷  Sign Up PRODUCT NAME: LOTILANER AND SALTS THEREOF; REG. NO/DATE: EU/2/17/206 20170427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.