XDEMVY Drug Patent Profile
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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-three 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
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Summary for XDEMVY
| International Patents: | 43 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for XDEMVY |
| What excipients (inactive ingredients) are in XDEMVY? | XDEMVY excipients list |
| DailyMed Link: | XDEMVY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XDEMVY
*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 XDEMVY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tarsus Pharmaceuticals, Inc. | Phase 4 |
Pharmacology for XDEMVY
| Drug Class | Ectoparasiticide |
US Patents and Regulatory Information for XDEMVY
XDEMVY is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XDEMVY is ⤷ Sign Up.
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting XDEMVY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ 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 | ||||
| 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 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 4790
Patent: DERIVADOS DE ISOOXAZOL SUSTITUIDOS, COMPOSICIONES FARMACEUTICAS Y PARA EL CONTROL DE PARASITOS QUE LOS COMPRENDEN Y SU USO EN METODOS PARA CONTROLAR PARASITOS EN Y SOBRE ANIMALES DE SANGRE CALIENTE.
Estimated Expiration: ⤷ Sign Up
Patent: 4474
Patent: COMPUESTOS DERIVADOS DE ISOOXAZOL SUSTITUIDOS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09327079
Patent: Isoxazoline derivatives and their use as pesticide
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0923009
Patent: Compsotos organicos
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 47354
Patent: COMPOSES ORGANIQUES (ORGANIC COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11001390
Patent: Compuestos derivados de isoxazolinas; composicion para el control de parasitos que comprende a dichos compuestos; y sus usos de dichos compuestos utiles para controlar ectoparasitos en y sobre animales de sangre caliente.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2256971
Patent: Isoxazoline derivatives and their use as pesticide
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 41475
Patent: COMPUESTOS ORGÁNICOS
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 79537
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 79537
Patent: Dérivés d'isoxazoline et leur utilisation en tant que pesticide (Isoxazoline derivatives and their use as pesticide)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 15568
Estimated Expiration: ⤷ Sign Up
Patent: 700034
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08676
Estimated Expiration: ⤷ Sign Up
Patent: 12512838
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0030
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11006568
Patent: COMPUESTOS ORGANICOS. (ISOXAZOLINE DERIVATIVES AND THEIR USE AS PESTICIDE.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 0891
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3135
Patent: ISOXAZOLINE DERIVATIVES AND THEIR USE AS PESTICIDE
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 17048
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 79537
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 79537
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 18462
Patent: ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ (ORGANIC COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1103780
Patent: ISOXAZOLINE DERIVATIVES AND THEIR USE AS PESTICIDE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 95704
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 54472
Estimated Expiration: ⤷ Sign Up
Patent: 1024289
Patent: Organic compounds
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Denmark | 2379537 | ⤷ Sign Up | |
| Canada | 2747354 | COMPOSES ORGANIQUES (ORGANIC COMPOUNDS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2010070068 | ⤷ Sign Up | |
| Spain | 2395704 | ⤷ Sign Up | |
| Israel | 307992 | פורמולציות קוטלות טפילים המכילות איזוקסאזולין ושיטות לטיפול בדלקת עפעפיים (Isoxazoline parasiticide formulations and methodsfor treating blepharitis) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XDEMVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2379537 | C02379537/01 | Switzerland | ⤷ Sign Up | PFANDNEHMER/IN: GOLDMAN SACHS BANK USA, 200 WEST STREET, NEW YORK, NY 10282, US |
| 2379537 | 132017000099235 | Italy | ⤷ Sign Up | PRODUCT NAME: LOTILANER(CREDELIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/2/17/206, 20170427 |
| 2379537 | 699 | Finland | ⤷ Sign Up | |
| 2379537 | CR 2017 00034 | Denmark | ⤷ Sign Up | PRODUCT NAME: LOTILANER OG SALTE DERAF; REG. NO/DATE: EU/2/17/206/001-015 20170427 |
| 2379537 | 2017048 | Norway | ⤷ Sign Up | PRODUCT NAME: LOTILANER; REG. NO/DATE: EU/2/17/206 20170523 |
| >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.
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