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Last Updated: November 10, 2024

Voclosporin - Generic Drug Details


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What are the generic drug sources for voclosporin and what is the scope of freedom to operate?

Voclosporin is the generic ingredient in one branded drug marketed by Aurinia and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Voclosporin has one hundred and ninety-three patent family members in thirty-nine countries.

There is one drug master file entry for voclosporin. One supplier is listed for this compound.

Summary for voclosporin
International Patents:193
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 30
Clinical Trials: 19
Patent Applications: 1,426
What excipients (inactive ingredients) are in voclosporin?voclosporin excipients list
DailyMed Link:voclosporin at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for voclosporin
Generic Entry Date for voclosporin*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
CAPSULE;ORAL

*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 voclosporin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2
Labcorp Drug Development, Inc.Phase 3
Leiden University Medical CenterPhase 2

See all voclosporin clinical trials

US Patents and Regulatory Information for voclosporin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 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 voclosporin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V. Lupkynis voclosporin EMEA/H/C/005256
Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).
Authorised no no no 2022-09-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for voclosporin

Country Patent Number Title Estimated Expiration
South Korea 20200007884 루푸스 신염의 치료를 위한 개선된 프로토콜 ⤷  Sign Up
Canada 2464423 ⤷  Sign Up
Chile 2019003249 Protocolo mejorado para el tratamiento de nefritis lúpica. ⤷  Sign Up
Norway 331745 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 03033527 ⤷  Sign Up
Australia 2024202977 Improved protocol for treatment of lupus nephritis ⤷  Sign Up
China 100344648 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.