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-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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XDEMVY
Generic Entry Date for XDEMVY*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XDEMVY is ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting XDEMVY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||||
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 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
Estimated Expiration: ⤷ Try a Trial
Patent: 4474
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09327079
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0923009
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 47354
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11001390
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2256971
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 41475
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 79537
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 79537
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 15568
Estimated Expiration: ⤷ Try a Trial
Patent: 700034
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 08676
Estimated Expiration: ⤷ Try a Trial
Patent: 12512838
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0030
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11006568
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0891
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3135
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 17048
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 79537
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 79537
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 18462
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1103780
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 95704
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 54472
Estimated Expiration: ⤷ Try a Trial
Patent: 1024289
Estimated Expiration: ⤷ Try a Trial
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) | ⤷ 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 XDEMVY
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 |