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-two patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for lotilaner
| International Patents: | 42 |
| 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tarsus | XDEMVY | lotilaner | SOLUTION/DROPS;OPHTHALMIC | 217603-001 | Jul 24, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| 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) | ⤷ Try a Trial |
| Mexico | 2011006568 | COMPUESTOS ORGANICOS. (ISOXAZOLINE DERIVATIVES AND THEIR USE AS PESTICIDE.) | ⤷ Try a Trial |
| Mexico | 2020006309 | FÓRMULACIONES DE PARASITICIDA DE ISOXAZOLINA Y MÉTODOS PARA EL TRATAMIENTO DE LA BLEFARITIS. (ISOXAZOLINE PARASITICIDE FORMULATIONS AND METHODS FOR TREATING BLEPHARITIS.) | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lotilaner
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2379537 | 2017C/029 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CREDELIO - LOTINALER; AUTHORISATION NUMBER AND DATE: EU/2/17/206 20170427 |
| 2379537 | SPC/GB17/052 | United Kingdom | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: LOTILANER; REGISTRATION NO/DATE: EU/2/17/206 20170425 |
| 2379537 | 2017/037 | Ireland | ⤷ Try a Trial | PRODUCT NAME: LOTILANER AND SALTS THEREOF.; REGISTRATION NO/DATE: EU/2/17/206 20170425 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
