VOCLOSPORIN - Generic Drug Details
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What are the generic sources for voclosporin and what is the scope of patent protection?
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
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
| Sponsor | Phase |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| Labcorp Drug Development, Inc. | Phase 3 |
| Leiden University Medical Center | Phase 2 |
Pharmacology 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurinia | LUPKYNIS | voclosporin | CAPSULE;ORAL | 213716-001 | Jan 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurinia | LUPKYNIS | voclosporin | CAPSULE;ORAL | 213716-001 | Jan 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurinia | LUPKYNIS | voclosporin | CAPSULE;ORAL | 213716-001 | Jan 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 |
|---|---|---|---|
| Ecuador | SP045061 | MEZCLAS ANALOGAS DE CICLOSPORINA Y SU USO COMO AGENTES INMUNOMODULADORES | ⤷ Try a Trial |
| Japan | 2009197036 | CYCLOSPORINE ANALOGUE MIXTURE AND USE THEREOF AS IMMUNOMODULATOR | ⤷ Try a Trial |
| European Patent Office | 1816138 | ⤷ Try a Trial | |
| Germany | 60227686 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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