Patent and Exclusivity Expirations Report

Report generated for the week of 2025-09-08 by Unibest Digital Center. Current analysis scope only include the US FDA.

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Summary of Expirations

This week, there are 6 drugs in the patent and exclusivity list. They are:

• Rytelo by Geron Corp, containing active ingredient Imetelstat Sodium

• EpiPen Jr. by Mylan Specialty LP, containing active ingredient Epinephrine

• EpiPen by Mylan Specialty LP, containing active ingredient Epinephrine

• Prolensa by Bausch and Lomb Inc, containing active ingredient Bromfenac Sodium

• Halaven by Eisai Inc, containing active ingredient Eribulin Mesylate

• Seizalam by Meridian Medical Technologies LLC, containing active ingredient Midazolam Hydrochloride

Patents Expiring This Week

BROMFENAC SODIUM - SOLUTION/DROPS;OPHTHALMIC - PROLENSA

From BAUSCH AND LOMB INC; an NSAID used to treat postoperative pain and inflammation of the eye.

EQ 0.07% ACID

Approved in Apr 5, 2013, used as Reference Listed Drug and Reference Standard

There are 2 future patent(s) for this application. The earliest expires on 2032-11-19, and the latest expires on 2033-11-11.

Patent No	Patent Expiration Date	Patent Title
8129431	2025-09-11	Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid

EPINEPHRINE - INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EPIPEN

From MYLAN SPECIALTY LP; used to treat severe life-threatening allergic reactions (anaphylaxis) to foods, drugs, insect stings or bites, and other allergens.

0.3MG/DELIVERY

Approved in Dec 22, 1987, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No	Patent Expiration Date	Patent Title
7794432	2025-09-11	Automatic injector with kickback attenuation
7449012	2025-09-11	Automatic injector
9586010	2025-09-11	Automatic injector with needle cover
8048035	2025-09-11	Automatic injector with needle cover
8870827	2025-09-11	Automatic injector

EPINEPHRINE - INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS - EPIPEN JR.

From MYLAN SPECIALTY LP; used to treat severe life-threatening allergic reactions (anaphylaxis) to foods, drugs, insect stings or bites, and other allergens.

0.15MG/DELIVERY

Approved in Dec 22, 1987, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No	Patent Expiration Date	Patent Title
7794432	2025-09-11	Automatic injector with kickback attenuation
8048035	2025-09-11	Automatic injector with needle cover
7449012	2025-09-11	Automatic injector
9586010	2025-09-11	Automatic injector with needle cover
8870827	2025-09-11	Automatic injector

IMETELSTAT SODIUM - POWDER;INTRAVENOUS - RYTELO

From GERON CORP; a human telomerase inhibitor used to treat myelodysplastic syndromes in patients with transfusion-dependent anemia.

EQ 188MG BASE/VIAL; EQ 47MG BASE/VIAL

Approved in Jun 6, 2024, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2025-12-27, and the latest expires on 2039-06-16.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
9388415	U-3956	TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA	2025-09-09	Modified oligonucleotides for telomerase inhibition
9388416	U-3956	TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA	2025-09-09	Modified oligonucleotides for telomerase inhibition

Exclusivities Expiring This Week

ERIBULIN MESYLATE - SOLUTION;INTRAVENOUS - HALAVEN

From EISAI INC; for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic cancer.

1MG/2ML (0.5MG/ML)

Approved in Nov 15, 2010, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-03-13, and the latest expires on 2026-03-13.

Exclusivity Date	Exclusivity Use Definition
2025-09-13	REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDIES E7389-G000-223 AND E7389-G000-213, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST

MIDAZOLAM HYDROCHLORIDE - SOLUTION;INTRAMUSCULAR - SEIZALAM

From MERIDIAN MEDICAL TECHNOLOGIES LLC; a short-acting benzodiazepine with rapid onset that is commonly used in seizures, anesthesia and anxiety disorders.

EQ 50MG BASE/10ML (EQ 5MG BASE/ML)

Approved in Sep 14, 2018, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-09-14	TREATMENT OF STATUS EPILEPTICUS IN ADULTS