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
| Sponsor | Phase |
|---|---|
| LianBio LLC | Phase 3 |
| Tarsus Pharmaceuticals, Inc. | Phase 2 |
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 | 11,690,827 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | 11,197,847 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | 11,752,137 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | 8,383,659 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| >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 |
|---|---|---|---|
| China | 102256971 | Isoxazoline derivatives and their use as pesticide | ⤷ Subscribe |
| Israel | 307992 | פורמולציות קוטלות טפילים המכילות איזוקסאזולין ושיטות לטיפול בדלקת עפעפיים (Isoxazoline parasiticide formulations and methodsfor treating blepharitis) | ⤷ Subscribe |
| Japan | 2024038449 | イソキサゾリン系寄生虫駆除剤及び眼瞼炎を治療する方法 (ISOXAZOLINE PARASITICIDE FORMULATIONS AND METHODS FOR TREATING BLEPHARITIS) | ⤷ Subscribe |
| Hungary | E015568 | ⤷ Subscribe | |
| European Patent Office | 2379537 | Dérivés d'isoxazoline et leur utilisation en tant que pesticide (Isoxazoline derivatives and their use as pesticide) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lotilaner
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2379537 | C02379537/01 | Switzerland | ⤷ Subscribe | PFANDNEHMER/IN: GOLDMAN SACHS BANK USA, 200 WEST STREET, NEW YORK, NY 10282, US |
| 2379537 | 699 | Finland | ⤷ Subscribe | |
| 2379537 | 2017048 | Norway | ⤷ Subscribe | PRODUCT NAME: LOTILANER; REG. NO/DATE: EU/2/17/206 20170523 |
| 2379537 | C201730034 | Spain | ⤷ Subscribe | PRODUCT NAME: LOTILANER Y SALES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/2/17/206; DATE OF AUTHORISATION: 20170425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/2/17/206; DATE OF FIRST AUTHORISATION IN EEA: 20170425 |
| 2379537 | CR 2017 00034 | Denmark | ⤷ Subscribe | PRODUCT NAME: LOTILANER OG SALTE DERAF; REG. NO/DATE: EU/2/17/206/001-015 20170427 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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