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Last Updated: October 1, 2022

LUPKYNIS Drug Patent Profile


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Which patents cover Lupkynis, and what generic alternatives are available?

Lupkynis is a drug marketed by Aurinia and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seventy-six patent family members in thirty-five countries.

The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. Additional details are available on the voclosporin profile page.

DrugPatentWatch® Generic Entry Outlook for Lupkynis

Lupkynis will be eligible for patent challenges on January 22, 2025. 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 January 22, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LUPKYNIS
International Patents:176
US Patents:2
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 1
Patent Applications: 948
What excipients (inactive ingredients) are in LUPKYNIS?LUPKYNIS excipients list
DailyMed Link:LUPKYNIS at DailyMed
Drug patent expirations by year for LUPKYNIS
DrugPatentWatch® Estimated Generic Entry Opportunity Date for LUPKYNIS
Generic Entry Date for LUPKYNIS*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
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 LUPKYNIS

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2

See all LUPKYNIS clinical trials

US Patents and Regulatory Information for LUPKYNIS

LUPKYNIS is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUPKYNIS is See Plans and Pricing.

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 LUPKYNIS

Protocol for treatment of lupus nephritis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS

Cyclosporine analogue mixtures and their use as immunomodulating agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS

FDA Regulatory Exclusivity protecting LUPKYNIS

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 LUPKYNIS

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 LUPKYNIS

See the table below for patents covering LUPKYNIS around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2116228 See Plans and Pricing
Russian Federation 2321593 СИНТЕЗ АНАЛОГОВ ЦИКЛОСПОРИНА (SYNTHESIS OF CICLOSPORIN ANALOGUES) See Plans and Pricing
Japan 2005522585 See Plans and Pricing
Japan 4261355 See Plans and Pricing
Uruguay 27501 NUEVAS FORMULACIONES DE ANÁLOGOS DE CICLOSPORINA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Moodys
AstraZeneca
Harvard Business School
Baxter

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.