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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 three patents protecting this drug.

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

The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. One supplier is listed 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:	193
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	1
Patent Applications:	584
Drug Prices:	Drug price information for LUPKYNIS
What excipients (inactive ingredients) are in LUPKYNIS?	LUPKYNIS excipients list
DailyMed Link:	LUPKYNIS at DailyMed

Drug patent expirations by year for LUPKYNIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUPKYNIS

Generic Entry Date for LUPKYNIS^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 213716 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

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

See all LUPKYNIS clinical trials

Pharmacology for LUPKYNIS

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for LUPKYNIS

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUPKYNIS 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 LUPKYNIS

Protocol for treatment of lupus nephritis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS

Cyclosporine analogue mixtures and their use as immunomodulating agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS

FDA Regulatory Exclusivity protecting LUPKYNIS

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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				⤷ Sign Up
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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 LUPKYNIS

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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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1435910	NOUVEAUX PRECONCENTRES EN MICROEMULSION D'ANALOGUES DE CYCLOSPORINE (NOVEL CYCLOSPORIN ANALOG MICROEMULSION PRECONCENTRATES)	⤷ Sign Up
Croatia	P20040354	NOVEL CYCLOSPORIN ANALOG MICROEMULSION PRECONCENTRATES	⤷ Sign Up
Slovenia	1436321		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration