Patent and Exclusivity Expirations Report

Report generated for the week of 2025-06-30 by Unibest Digital Center. Current analysis scope only include the US FDA.

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Summary of Expirations

This week, there are 4 drugs in the patent and exclusivity list. They are:

• Farxiga by AstraZeneca AB, containing active ingredient Dapagliflozin

• Ryanodex by Eagle Pharmaceuticals Inc, containing active ingredient Dantrolene Sodium

• Dojolvi by Ultragenyx Pharmaceutical Inc, containing active ingredient Triheptanoin

• Rukobia by ViiV Healthcare Co, containing active ingredient Fostemsavir Tromethamine

Patents Expiring This Week

DANTROLENE SODIUM - FOR SUSPENSION;INTRAVENOUS - RYANODEX

From EAGLE PHARMACEUTICALS INC; a direct-acting skeletal muscle relaxant used for the treatment of management of the fulminant hypermetabolism of skeletal muscle leading to malignant hyperthermia crisis.

250MG/VIAL

Approved in Jul 22, 2014, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No	Patent Expiration Date	Patent Title
7758890	2025-06-30	Treatment using dantrolene

DAPAGLIFLOZIN - TABLET;ORAL - FARXIGA

From ASTRAZENECA AB; a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus.

10MG

Approved in Jan 8, 2014, used as Reference Listed Drug and Reference Standard

5MG

Approved in Jan 8, 2014, used as Reference Listed Drug

There are 32 future patent(s) for this application. The earliest expires on 2025-10-04, and the latest expires on 2041-04-01.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
7456254	U-2139	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE	2025-06-30	Polymer-based sustained release device

TRIHEPTANOIN - LIQUID;ORAL - DOJOLVI

From ULTRAGENYX PHARMACEUTICAL INC; a medium chain triglyceride indicated to provide calories and fatty acids to treat long chain fatty acid oxidation disorders.

100% w/w

Approved in Jun 30, 2020, used as Reference Listed Drug and Reference Standard

There are 1 future patent(s) for this application. The earliest expires on 2029-04-28, and the latest expires on 2029-04-28.

Patent No	Patent Expiration Date	Patent Title
9186344	2025-07-01	Glycogen or polysaccharide storage disease treatment method

Exclusivities Expiring This Week

FOSTEMSAVIR TROMETHAMINE - TABLET, EXTENDED RELEASE;ORAL - RUKOBIA

From VIIV HEALTHCARE CO; an antiretroviral HIV-1 attachment inhibitor targeted against the gp120 subunit within the HIV-1 gp160 envelope glycoprotein.

EQ 600MG BASE

Approved in Jul 2, 2020, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-07-02	NEW CHEMICAL ENTITY

TRIHEPTANOIN - LIQUID;ORAL - DOJOLVI

From ULTRAGENYX PHARMACEUTICAL INC; a medium chain triglyceride indicated to provide calories and fatty acids to treat long chain fatty acid oxidation disorders.

100% w/w

Approved in Jun 30, 2020, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-06-30, and the latest expires on 2027-06-30.

Exclusivity Date	Exclusivity Use Definition
2025-06-30	NEW CHEMICAL ENTITY