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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Questions you can ask:
- What is the 5 year forecast for LUPKYNIS?
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
Pharmacology for LUPKYNIS
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
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 | ||
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 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 |
---|---|---|---|
Mexico | PA04003624 | MEZCLAS ANALOGAS DE CICLOSPORINA Y SU USO COMO AGENTES INMUNOLOMODULADORES. (CYCLOSPORINE ANALOGUE MIXTURES AND THEIR USE AS IMMUNOMODULATING AGENTS.) | ⤷ Sign Up |
South Africa | 200402269 | SYNTHESIS OF CYCLOSPORIN ANALOGS | ⤷ Sign Up |
Canada | 2460685 | MELANGES D'ANALOGUES DE CYCLOSPORINE ET LEUR UTILISATION COMME AGENTS IMMUNOMODULATEURS (CYCLOSPORINE ANALOGUE MIXTURES AND THEIR USE AS IMMUNOMODULATING AGENTS) | ⤷ Sign Up |
Poland | 370772 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |