Patent and Exclusivity Expirations Report

Report generated for the week of 2025-03-17 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 9 drugs in the patent and exclusivity list. They are:

• Xtampza ER by Collegium Pharmaceutical Inc, containing active ingredient Oxycodone

• Glumetza by Santarus Inc, containing active ingredient Metformin Hydrochloride

• Opzelura by Incyte Corp, containing active ingredient Ruxolitinib Phosphate

• Jakafi by Incyte Corp, containing active ingredient Ruxolitinib Phosphate

• Smoflipid 20% by Fresenius Kabi USA LLC, containing active ingredient Fish Oil, Medium Chain Triglycerides, Olive Oil, and Soybean Oil

• Tasigna by Novartis Pharmaceuticals Corp, containing active ingredient Nilotinib Hydrochloride

• Xelstrym by Noven Pharmaceuticals Inc, containing active ingredient Dextroamphetamine

• Hyftor by Nobelpharma Co Ltd, containing active ingredient Sirolimus

• Locametz by Novartis Pharmaceuticals Corp, containing active ingredient Gallium Ga-68 Gozetotide

Patents Expiring This Week

METFORMIN HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - GLUMETZA

From SANTARUS INC; used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus.

1GM

Approved in Jun 3, 2005, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No	Patent Expiration Date	Patent Title
7780987	2025-03-23	Controlled release dosage forms

OXYCODONE - CAPSULE, EXTENDED RELEASE;ORAL - XTAMPZA ER

From COLLEGIUM PHARMACEUTICAL INC; for the treament of moderate to severe pain.

9MG; 13.5MG; 18MG; 27MG

Approved in Apr 26, 2016, used as Reference Listed Drug

36MG

Approved in Apr 26, 2016, used as Reference Listed Drug and Reference Standard

There are 11 future patent(s) for this application. The earliest expires on 2025-03-24, and the latest expires on 2036-09-02.

Patent No	Patent Expiration Date	Patent Title
8557291	2025-03-21	Abuse-deterrent pharmaceutical compositions of opioids and other drugs

Exclusivities Expiring This Week

DEXTROAMPHETAMINE - SYSTEM;TRANSDERMAL - XELSTRYM

From NOVEN PHARMACEUTICALS INC; for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

4.5MG/9HR; 13.5MG/9HR; 9MG/9HR

Approved in Mar 22, 2022, used as Reference Listed Drug

18MG/9HR

Approved in Mar 22, 2022, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-03-22	NEW PRODUCT

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - EMULSION;INTRAVENOUS - SMOFLIPID 20%

From FRESENIUS KABI USA LLC; for aiding diet needs as intravenous nutritional products.

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)

Approved in Aug 10, 2018, used as Reference Listed Drug and Reference Standard

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)

3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)

Approved in Jul 13, 2016, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-03-22	NEW PATIENT POPULATION

GALLIUM GA-68 GOZETOTIDE - POWDER;INTRAVENOUS - LOCAMETZ

From NOVARTIS PHARMACEUTICALS CORP; a radiopharmaceutical agent used in the diagnosis of prostate-specific membrane antigen (PSMA) positive lesions in male patients during positron emission tomography.

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-03-23	NEW PRODUCT

NILOTINIB HYDROCHLORIDE - CAPSULE;ORAL - TASIGNA

From NOVARTIS PHARMACEUTICALS CORP; used for the chronic phase treatment of Chronic Myeloid Leukemia (CML) that is Philadelphia chromosome positive and for the treatment of CML that is resistant to therapy containing imatinib.

EQ 150MG BASE

Approved in Jun 17, 2010, used as Reference Listed Drug

EQ 200MG BASE

Approved in Oct 29, 2007, used as Reference Listed Drug and Reference Standard

EQ 50MG BASE

Approved in Mar 22, 2018, used as Reference Listed Drug

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-09-22, and the latest expires on 2029-03-23.

Exclusivity Date	Exclusivity Use Definition
2025-03-22	TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA WITH RESISTANCE OR INTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR THERAPY
2025-03-22	TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML) IN CHRONIC PHASE

RUXOLITINIB PHOSPHATE - CREAM;TOPICAL - OPZELURA

From INCYTE CORP; used to treat various types of myelofibrosis, polycythemia vera in patients who have not responded to or cannot tolerate hydroxyurea, and to treat graft-versus-host disease in cases that are refractory to steroid treatment.

EQ 1.5% BASE

Approved in Sep 21, 2021, used as Reference Listed Drug and Reference Standard

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-07-18, and the latest expires on 2026-01-18.

Exclusivity Date	Exclusivity Use Definition
2025-03-21	PEDIATRIC EXCLUSIVITY

RUXOLITINIB PHOSPHATE - TABLET;ORAL - JAKAFI

From INCYTE CORP; used to treat various types of myelofibrosis, polycythemia vera in patients who have not responded to or cannot tolerate hydroxyurea, and to treat graft-versus-host disease in cases that are refractory to steroid treatment.

EQ 10MG BASE; EQ 5MG BASE

Approved in Nov 16, 2011, used as Reference Listed Drug

There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-12-19, and the latest expires on 2029-03-22.

Exclusivity Date	Exclusivity Use Definition
2025-03-22	PEDIATRIC EXCLUSIVITY

SIROLIMUS - GEL;TOPICAL - HYFTOR

From NOBELPHARMA CO LTD; used to prevent organ transplant rejections, treat lymphangioleiomyomatosis, and treat adults with perivascular epithelioid cell tumors.

0.2%

Approved in Mar 22, 2022, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-03-22, and the latest expires on 2029-03-22.

Exclusivity Date	Exclusivity Use Definition
2025-03-22	NEW PRODUCT