Aurinia Pharmaceuticals (AUPH) deal pushes back Teva lupus drug generic
Rhea-AI Filing Summary
Aurinia Pharmaceuticals Inc. (AUPH) reports that it and its U.S. subsidiary have entered into a settlement agreement with Teva Pharmaceuticals Inc. resolving U.S. patent litigation over Teva’s proposed generic 7.9 mg voclosporin oral capsules. Teva has stipulated that Aurinia’s U.S. Patent Nos. 10,286,036 and 11,622,991, which expire in December 2037, are enforceable, valid, and would be infringed by commercial sales of its generic product in the United States.
The settlement permits Teva to launch its generic voclosporin product in the United States no earlier than December 7, 2036, subject to defined contingencies and to obtaining FDA approval. Aurinia’s related patent infringement actions continue against several other generic manufacturers in the U.S. District Court for the District of New Jersey.
Positive
- Settlement with Teva defers U.S. generic entry for voclosporin until at least December 7, 2036, supporting an extended period of branded-market exclusivity relative to the December 2037 patent expirations.
Negative
- None.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Earliest Teva generic launch date: December 7, 2036
Voclosporin patent expirations: December 2037
Generic voclosporin strength: 7.9 mg
+2 more
5 metrics
Earliest Teva generic launch date
December 7, 2036
Date before which Teva may not launch its generic voclosporin product in the U.S. under the settlement
Voclosporin patent expirations
December 2037
Expiry date for U.S. Patent Nos. 10,286,036 and 11,622,991 covering voclosporin
Generic voclosporin strength
7.9 mg
Strength of Teva’s proposed generic voclosporin oral capsules
LUPKYNIS FDA approval timing
January 2021
Month and year Aurinia introduced LUPKYNIS as the first FDA‑approved oral therapy for adult lupus nephritis
U.S. voclosporin patents
10,286,036; 11,622,991
Patent numbers Teva stipulated are enforceable, valid, and would be infringed by its generic product
Key Terms
Abbreviated New Drug Application, lupus nephritis, B cell-activating factor (BAFF), a proliferation-inducing ligand (APRIL), +1 more
5 terms
Abbreviated New Drug Application regulatory
"relating to Teva’s filing of an Abbreviated New Drug Application seeking to market"
An abbreviated new drug application is a regulatory submission used to gain approval to market a generic version of an already approved prescription medicine by showing it is equivalent in effect and safety to the original product, without repeating full clinical trials. For investors, an approval signals a lower-cost competitor entering the market that can quickly capture sales from the branded drug, similar to a generic knock‑off replacing a name‑brand item on store shelves.
lupus nephritis medical
"the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis"
Lupus nephritis is a condition in which a person’s immune system attacks the kidneys, causing inflammation and damage to the organs’ filtering function and leading to blood or protein in the urine and, in severe cases, kidney failure. For investors, it defines a specific, medically serious patient group and treatment need: success or failure of therapies, clinical trials, regulatory approvals, and pricing decisions for drugs aimed at this condition can meaningfully change a biotech or pharma company’s revenue prospects — like fixing a costly, central leak in a building that determines the value of the whole property.
B cell-activating factor (BAFF) medical
"aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand"
a proliferation-inducing ligand (APRIL) medical
"dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL)"
A proliferation-inducing ligand (APRIL) is a naturally occurring protein that helps certain immune cells—especially antibody-producing B cells and plasma cells—survive and multiply. Investors pay attention because drugs that block or mimic APRIL can alter the course of cancers and autoimmune diseases; positive or negative clinical and regulatory news about APRIL-targeting therapies can quickly change a biotech’s prospects, much like a key ingredient deciding whether a recipe succeeds or fails.
forward-looking information regulatory
"This press release contains forward-looking information within the meaning of applicable Canadian"
Forward-looking information are predictions, plans, estimates or expectations about a company’s future performance, results or events, such as sales forecasts, project timelines, or anticipated costs. It matters to investors because these statements guide expectations but rely on assumptions and uncertain factors—like a weather forecast for a business—so investors should treat them as informed guesses rather than guarantees and consider the risks and possible changes behind the numbers.
FAQ
What patent litigation settlement did AUPH announce with Teva on August 19, 2026?
Aurinia Pharmaceuticals Inc. announced a settlement with Teva Pharmaceuticals Inc. resolving U.S. patent litigation over Teva’s proposed generic 7.9 mg voclosporin capsules. Teva stipulated Aurinia’s key U.S. voclosporin patents are enforceable, valid, and would be infringed by its generic product.
When can Teva launch its generic voclosporin product under the AUPH settlement?
Under the settlement, Teva may launch its generic voclosporin product in the United States no earlier than December 7, 2036. Earlier entry is possible only if specified contingencies occur, and Teva must still obtain FDA approval for its product.
How long do Aurinia’s key U.S. voclosporin patents last according to the filing for AUPH?
Aurinia states that U.S. Patent Nos. 10,286,036 and 11,622,991 related to voclosporin expire in December 2037. These patents underpin the settlement with Teva, which restricts U.S. generic entry until at least December 7, 2036, absent specified contingencies.
Does AUPH still have ongoing patent cases against other generic companies?
Yes. Aurinia reports that patent infringement actions continue against multiple generic manufacturers, including DifGen, Dr. Reddy’s, Galenicum, Hikma, Lotus, Sandoz, and Zydus. These cases are pending in the U.S. District Court for the District of New Jersey.
What is Aurinia’s main approved product mentioned in the AUPH filing?
Aurinia highlights LUPKYNIS® (voclosporin), introduced in January 2021 as the first FDA‑approved oral therapy for adult patients with active lupus nephritis. This product is central to the Teva patent settlement involving generic voclosporin capsules.
What pipeline asset besides voclosporin does AUPH mention in this disclosure?
Aurinia reports it is developing aritinercept, described as a dual inhibitor of B cell‑activating factor (BAFF) and a proliferation‑inducing ligand (APRIL). The company is exploring aritinercept for the potential treatment of autoimmune diseases.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 19, 2026
(Exact name of registrant as specified in its charter)
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| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
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| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on which Registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01 | Other Events | ||||
On August 19, 2026, Aurinia Pharmaceuticals Inc. (Aurinia or the Company) issued a press release announcing that it and its subsidiary, Aurinia Pharma U.S., Inc., (collectively, “Aurinia”) have entered into a settlement agreement with Teva Pharmaceuticals Inc. (“Teva”) to resolve patent infringement litigation relating to Teva’s filing of an Abbreviated New Drug Application seeking to market its generic 7.9 mg voclosporin oral capsules in the United States. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any of our filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
The information contained in the press release is summary information that is intended to be considered in the context of our Securities and Exchange Commission filings and other public announcements that we may make, by press release or otherwise, from time to time. We undertake no duty or obligation to publicly update or revise such information, except as required by law.
| Item 9.01 | Financial Statements and Exhibits | ||||
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | Press release dated August 19, 2026 | |||||||
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 19, 2026
| AURINIA PHARMACEUTICALS INC. | ||||||||
| By: | /s/ Stephen P. Robertson | |||||||
| Name: | Stephen P. Robertson | |||||||
| Title: | Chief Legal Officer, Corporate Secretary and Chief Compliance Officer | |||||||
Exhibit 99.1 | ||||||||
 | ||||||||
Aurinia Settles Patent Litigation with Teva
EDMONTON, Alberta – August 19, 2026 – Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that it and its subsidiary, Aurinia Pharma U.S., Inc., (collectively, “Aurinia”) have entered into a settlement agreement with Teva Pharmaceuticals Inc. (“Teva”) to resolve patent infringement litigation relating to Teva’s filing of an Abbreviated New Drug Application seeking to market its generic 7.9 mg voclosporin oral capsules in the United States.
Under the terms of the settlement, Teva has stipulated that Aurinia’s U.S. Patent Nos. 10,286,036 and 11,622,991 (which expire in December 2037) are enforceable, valid, and would be infringed by commercial sales within the United States of its generic voclosporin product. The settlement further provides that Teva may launch its generic voclosporin product no earlier than December 7, 2036, unless certain defined contingencies occur earlier. Teva’s ability to market its generic voclosporin product in the United States will also be contingent on Teva obtaining approval from the United States Food and Drug Administration.
Aurinia’s related patent infringement actions continue against each of DifGen Pharmaceuticals LLC, Dr. Reddy's Laboratories, Inc. and its affiliate, Galenicum Health S.L.U., Hikma Pharmaceuticals USA Inc., Lotus Pharmaceutical Co. Ltd. and its affiliate, Sandoz Inc., and Zydus Pharmaceuticals (USA) Inc. and its affiliate, in the United States District Court for the District of New Jersey.
About Aurinia
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
Forward-Looking Statements
This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com.
Investor Inquiries
ir@auriniapharma.com