Patent and Exclusivity Expirations Report

Report generated for the week of 2025-01-20 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 7 drugs in the patent and exclusivity list. They are:
- CUMBERLAND PHARMACEUTICALS INC's SANCUSO, containing active ingredient GRANISETRON
- AZURITY PHARMACEUTICALS INC's HORIZANT, containing active ingredient GABAPENTIN ENACARBIL
- GILEAD SCIENCES INC's VEKLURY, containing active ingredient REMDESIVIR
- ASTRAZENECA AB's BYDUREON BCISE, containing active ingredient EXENATIDE SYNTHETIC
- EPIZYME INC's TAZVERIK, containing active ingredient TAZEMETOSTAT HYDROBROMIDE
- EVOFEM INC's SOLOSEC, containing active ingredient SECNIDAZOLE
- ADVANCED ACCELERATOR APPLICATIONS USA INC's LUTATHERA, containing active ingredient LUTETIUM LU 177 DOTATATE

Patents Expiring This Week

GABAPENTIN ENACARBIL - TABLET, EXTENDED RELEASE;ORAL - HORIZANT

From AZURITY PHARMACEUTICALS INC; for treating Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).

300MG

Approved in Dec 13, 2011, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-04-06, and the latest expires on 2029-06-10.

600MG

Approved in Apr 6, 2011, used as Reference Listed Drug and Reference Standard

There are 4 future patent(s) for this application. The earliest expires on 2025-04-06, and the latest expires on 2029-06-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
8686034	U-1231	TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS	2025-01-24	Crystalline form of γ-aminobutyric acid analog
8686034	U-1247	MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS	2025-01-24	Crystalline form of γ-aminobutyric acid analog

GRANISETRON - FILM, EXTENDED RELEASE;TRANSDERMAL - SANCUSO

From CUMBERLAND PHARMACEUTICALS INC; for treating nausea and vomiting in cancer therapy and postoperatively.

3.1MG/24HR

Approved in Sep 12, 2008, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
7608282	U-1011	USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING	2025-01-22	Transdermal granisetron

Exclusivities Expiring This Week

EXENATIDE SYNTHETIC - SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - BYDUREON BCISE

From ASTRAZENECA AB; for managing type 2 diabetes mellitus.

2MG/0.85ML (2MG/0.85ML)

Approved in Oct 20, 2017, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-01-22	PEDIATRIC EXCLUSIVITY

LUTETIUM LU 177 DOTATATE - SOLUTION;INTRAVENOUS - LUTATHERA

From ADVANCED ACCELERATOR APPLICATIONS USA INC; for treating somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors.

10mCi/ML

Approved in Jan 26, 2018, used as Reference Listed Drug and Reference Standard

There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-07-26, and the latest expires on 2031-10-23.

Exclusivity Date	Exclusivity Use Definition
2025-01-26	TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS

REMDESIVIR - POWDER;INTRAVENOUS - VEKLURY

From GILEAD SCIENCES INC; for treating RNA virus infections including COVID-19.

100MG/VIAL

Approved in Oct 22, 2020, used as Reference Listed Drug and Reference Standard

There are 7 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-25, and the latest expires on 2027-01-13.

Exclusivity Date	Exclusivity Use Definition
2025-01-21	3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH

REMDESIVIR - SOLUTION;INTRAVENOUS - VEKLURY

From GILEAD SCIENCES INC; for treating RNA virus infections including COVID-19.

100MG/20ML (5MG/ML)

Approved in Oct 22, 2020, used as Reference Listed Drug and Reference Standard

There are 7 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-25, and the latest expires on 2027-01-13.

Exclusivity Date	Exclusivity Use Definition
2025-01-21	3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH

SECNIDAZOLE - GRANULE;ORAL - SOLOSEC

From EVOFEM INC; for treating bacterial vaginosis.

2GM/PACKET

Approved in Sep 15, 2017, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-15, and the latest expires on 2027-09-15.

Exclusivity Date	Exclusivity Use Definition
2025-01-26	NEW PATIENT POPULATION

TAZEMETOSTAT HYDROBROMIDE - TABLET;ORAL - TAZVERIK

From EPIZYME INC; for treating patients 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

EQ 200MG BASE

Approved in Jan 23, 2020, used as Reference Listed Drug and Reference Standard

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-01-23, and the latest expires on 2027-06-18.

Exclusivity Date	Exclusivity Use Definition
2025-01-23	NEW CHEMICAL ENTITY