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LUPKYNIS

NDA

VOCLOSPORIN | N213716 | AURINIA PHARMACEUTICALS INC

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivityIPRPTAB Challenge

2026

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Today

7332472

Oct. 17, 2027

10286036

Dec. 7, 2037IPR

11622991

Dec. 7, 2037

NCE

Jan. 22, 2026

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-00617	10286036	IPR	Sun Pharmaceutical Industries Ltd. et al.	Terminated-Settled	2022-02-24	2023-01-25

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

9 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
AURINIA PHARMACEUTICALS INC. v. SANDOZ INC. 2:2025cv03986 2 patentsANDA 220223voclosporin	D.N.J.	2025-05-08	Terminated 2025-12-03	—
Aurinia Pharmaceuticals Inc. v. DifGen Pharmaceuticals LLC 1:2025cv00530 2 patentsANDA 220332voclosporin	D. Del.	2025-05-01	Terminated 2025-07-17	—
AURINIA PHARMACEUTICALS INC. v. DR. REDDY'S LABORATORIES, INC. et al 2:2025cv03693 2 patentsANDA 220252voclosporin	D.N.J.	2025-05-01	Terminated 2025-12-03	—
AURINIA PHARMACEUTICALS INC. v. DIFGEN PHARMACEUTICALS LLC 2:2025cv03533 2 patentsANDA 220332voclosporin	D.N.J.	2025-04-30	Terminated 2025-12-03	—
AURINIA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS, INC. et al 2:2025cv03267 2 patentsANDA 220211voclosporin	D.N.J.	2025-04-25	Terminated 2025-12-03	—
AURINIA PHARMACEUTICALS INC. v. ZYDUS PHARMACEUTICALS (USA) INC. al 2:2025cv02893 2 patentsANDA 220141voclosporin	D.N.J.	2025-04-21	Terminated 2025-12-03	—
AURINIA PHARMACEUTICALS INC. v. GALENICUM HEALTH S.L.U. 2:2025cv02807 2 patentsANDA 220072voclosporin	D.N.J.	2025-04-17	Terminated 2025-12-03	—
AURINIA PHARMACEUTICALS INC. v. LOTUS PHARMACEUTICAL CO., LTD. 2:2025cv02613 2 patentsANDA 220206voclosporin	D.N.J.	2025-04-11	Terminated 2025-12-03	—
AURINIA PHARMACEUTICALS INC. v. HIKMA PHARMACEUTICALS USA INC. 2:2025cv02580 2 patentsANDA 219663voclosporin	D.N.J.	2025-04-10	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lupkynis (2023)

Total Spending

$20.2M

Total Claims

1,676

Beneficiaries

299

Avg Cost/Unit

$77.92

Spending Trend

$4.1M(2021)→$12.6M(2022)→$20.2M(2023)

YoY Change:+7.7%

5yr CAGR:+7.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

LONZA AGVOCLOSPORIN

DMF 337792020

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDVOCLOSPORIN

DMF 395562024

TAPI NL BVVOCLOSPORIN

DMF 400892024

MEDICHEM SAVOCLOSPORIN

DMF 401622024

CONCORD BIOTECH LTDVOCLOSPORIN

DMF 406442024

INDENA SPAVOCLOSPORIN

DMF 406492024

DR REDDYS LABORATORIES LTDVOCLOSPORIN

DMF 410262024

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDVOCLOSPORIN

DMF 425842025

LONZA AGInactiveVOCLOSPORIN (IE-001)

DMF 233352009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 9, 2025	SUPPL -8	View Letter (PDF)
Apr 30, 2024	SUPPL -4	View Letter (PDF)
Jan 25, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 7.9MG

RLD

3 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Jan 22, 2021

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7332472	Oct 17, 2027	—	Yes	Yes	—
10286036	Dec 7, 2037	—	—	—	—
11622991	Dec 7, 2037	—	—	—	—

Exclusivities (1)

Code	Date	Status
NCE	Jan 22, 2026	Expired