Voclosporin - Generic Drug Details

What are the generic 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 eighty-eight patent family members in thirty-eight countries.

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

Summary for voclosporin

International Patents:	188
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

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

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

See all voclosporin clinical trials

Pharmacology for voclosporin

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

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

International Patents for voclosporin

Country	Patent Number	Title	Estimated Expiration
Slovenia	1436321
Canada	2461740	SYNTHESE D'ANALOGUES DE CYCLOSPORINE (SYNTHESIS OF CYCLOSPORIN ANALOGS)
South Africa	201907460	IMPROVED PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS
Ecuador	SP045061	MEZCLAS ANALOGAS DE CICLOSPORINA Y SU USO COMO AGENTES INMUNOMODULADORES