5 unchanged sentences
the OHSU licensed ‘190 Patent, expiration date January 2038;
−Removed: and our US 11,291,728 Patent (the “US ’728 Patent”), expiration date July 2039.
−Removed: On January 6, 2023, we received a letter dated January 5, 2023, notifying us that CIPLA submitted to the FDA a Paragraph IV Certification on our newly issued US 11,510,984 Patent (the “US ’984 Patent”).
+Added: and our US 11,291,728 Patent (the “’728 Patent”), expiration date July 2039.
+Added: On January 6, 2023, we received a letter dated January 5, 2023, notifying us that CIPLA submitted to the FDA a Paragraph IV Certification on our newly issued US 11,510,984 Patent (the “’984 Patent”).
These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for PEDMARK ® .
4 unchanged sentences
2:23-cv-00123), for infringement of the US ‘190 Patent, the US ‘728 Patent, and the US ‘984 Patent.
−Removed: On April 20, 2023, we filed an Amended Complaint to assert infringement of the ’728 Patent and the ’984 Patent.
+Added: On April 20, 2023, we filed an Amended Complaint to assert infringement of the US ‘728 Patent and the US ‘984 Patent.
On April 4, 2023, we were granted US 11,617,793 Patent (the “US ‘793 Patent”) covering the formulation of the PEDMARK ® product, which was listed in the Orange Book on or around April 17, 2023, and has an expiration date of July 2039.
On May 11, 2023, we received written notice of CIPLA’s Paragraph IV Certification as to the US ‘793 Patent, which was dated May 10, 2023, along with an enclosed statement of alleged factual and legal bases for stating that the US ‘793 Patent is invalid, unenforceable, and/or will not be infringed by CIPLA’s ANDA Product.
−Removed: On July 27, 2023, we filed a Second Amended Complaint to assert the US ‘793 Patent.
+Added: On July 27, 2023, we filed a Second
+Added: Amended Complaint to assert the US ‘793 Patent.
CIPLA filed an Answer to the Second Amended Complaint on August 31, 2023.
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In coordination with the Third Amended Complaint, we entered into a covenant not to sue CIPLA on the US ‘363 Patent, US ‘728 Patent, US ‘984 Patent, US ‘530 Patent, and US ‘604 Patent, subject to the limitation that such shall not apply to the extent CIPLA alters the product or formulation described in its FDA ANDA application.
−Removed: The suit is ongoing.
+Added: On May 27, 2025, we were granted US 12,311,026 (the “US ‘026 Patent”) covering a method of using pharmaceutical compositions comprising sodium thiosulfate and specific stabilizers to reduce ototoxicity in a patient receiving a platinum based chemotherapeutic for the treatment of a cancer.
+Added: The US ‘026 Patent has an expiration date of July 2039.
+Added: On May 27, 2025, we filed suit against the CIPLA entities in the United States District Court for the District of New Jersey (Case No.
+Added: 2:25-cv-05709), for infringement of the US ‘026 Patent based on the Cipla entities’ ANDA filing.
+Added: Subsequently, we filed a Motion to Consolidate Case No.
+Added: 2:25-cv-05709 and Case No.
+Added: 2:23-cv-00123.
+Added: On July 14, 2025, the court granted the Motion to Consolidate Case No.
+Added: 2:25-cv-05709 with Case No.
+Added: 2:23-cv-00123.
+Added: On July 14, 2025, the court issued its Order on Claim Construction on two claim terms in dispute in the ‘793 Patent and ‘018 Patent, adopting our proposed constructions for both.
+Added: On August 25, 2025, the CIPLA entities filed an Answer and Counterclaims to the complaint, alleging that the ‘026 Patent was invalid, not infringed, and/or unenforceable.
+Added: On September 18, 2025, we filed an Answer to CIPLA’s Counterclaims.
+Added: On March 16, 2026, Fennec announced that it has entered into an agreement with Cipla Limited and Cipla USA, Inc.
+Added: to settle the litigation between them regarding Cipla’s application to FDA for approval to market a generic version of Fennec’s PEDMARK® (sodium thiosulfate injection) product.
+Added: See Fennec Pharmaceuticals Inc.
+Added: Cipla Limited and Cipla USA, Inc ., C.A.
+Added: 2:23-cv-00123-JKS-MAH (D.N.J.).
+Added: Under the terms of the agreement, the lawsuit will be dismissed with each party bearing their own costs, and Cipla will not enter the market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain circumstances.
Mine Safety Disclosures
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.