AUPH PR on settlement of patent disputes with the Indian generic company, Sun is very brief. See entire substantive portion of press release below*. Nothing more filed with SEC.
High level of settlement is the following**:
Sun gets out of patent infringement litigation and gets covenant not to sue from AUPH for AUPH's '375 and '871 Patents covering Sun's Cequa product for DED
Sun agrees to drop USPTO challenge (IPR) against AUPH's '036 Patent
'036 Patent relates to using eGFR for dose adjustments to voclosporin for treating Lupus Nephritis (See FIGs. 1 and 2).
More about Cequa and LUPKYINS
Sun's Cequa is an improved version of Restasis and was expected to generate peak sales of $70M over 2 years (Sun Pharma launches dry eye drug in U.S. after-nine-month-delay)
Apparently there are at least 10 generic competitors for Restasis that filed for approval as of Oct 2019
AUPH guided LUPKYNIS (voclosporin) 2022 sales at ~$100M (AUPH Q3 2022 Results PR)
Neither Cequa nor LUPKYNIS appear destined to be blockbuster status any time soon
If there were more material terms to settlement, AUPH likely would have disclosed them in today's SEC filing.
Maybe Sun was happy essentially with royalty-free license, especially if Voclosporin revenue with eGFR dosing label is much less than initially projected
More About Lupkynis Protection from Competition
Orange Book composition of matter patent expired Oct 17, 2022
U.S. Pat. No.7332472 (now expired) covered isomeric cyclosporine analogue mixtures
U.S. Pat. No. 10,286,036 expires 12/7/37
AUPH also has FDA NCE exclusivity on LUPKYINS thru 1/22/26
See the full article on AUPH in our Amp forum HERE.
To see the full table of PDUFAs with extra information, read our January Biotech PDUFAs Forum post article for subscribers. Learn more here about signing up for BPIQ.*
FIG. 1 . Front page of AUPH's '036 Patent
FIG. 2 Independent claim of AUPH's '036 Patent
*Full text of substantive portion of PR and today's SEC filing by AUPH: "On January 3, 2023, Aurinia announced it has entered into a settlement agreement with Sun Pharmaceutical Industries, Inc., Sun Pharmaceuticals Industries, Ltd., and Sun Pharma Global FZE (collectively, Sun Pharmaceuticals) that involves both Aurinia and Sun Pharmaceuticals filing a joint motion to terminate the ongoing Inter Partes Review (IPR) directed at Aurinia’s U.S. Patent No. 10,286,036, as well as settlement of the ongoing patent infringement litigation in the United States (U.S.) related to Sun’s CEQUA® product. Under the settlement agreement, which is contingent upon the U.S. Patent Trial and Appeal Board approving the joint motion to terminate the IPR, both parties agreed to dismiss their claims and counterclaims against each other and cease bringing any future further action against the other."
**Our assumption of terms based on press release and substantively identical SEC filing.
See the full article on AUPH in our Amp forum HERE.
Published 1/3/23
To see the full table of PDUFAs with extra information, read our January Biotech PDUFAs Forum post article for subscribers. Learn more here about signing up for BPIQ.*
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