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Drug Patent & Exclusivity Expiration Report - Week of Jan 06 2025

Views: 50     Author: Unibest Industrial     Publish Time: 2025-01-06      Origin: Site

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Patent and Exclusivity Expirations Report

Report generated for the week of 2025-01-06 by Unibest Digital Center. Current analysis scope only include the US FDA.

Patent & Exclusitivity Expiration 20250106 1Patent & Exclusitivity Expiration 20250106 2Patent & Exclusitivity Expiration 20250106 3Patent & Exclusitivity Expiration 20250106 4

Summary of Expirations

This week, there are 8 drugs in the patent and exclusivity list. They are:
- AZURITY PHARMACEUTICALS INC's EDARBI, containing active ingredient AZILSARTAN KAMEDOXOMIL
- ABBVIE INC's TRILIPIX, containing active ingredient CHOLINE FENOFIBRATE
- AZURITY PHARMACEUTICALS INC's EDARBYCLOR, containing active ingredient AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
- TEVA NEUROSCIENCE INC's UZEDY, containing active ingredient RISPERIDONE
- TEVA PHARMACEUTICAL INDUSTRIES LTD's AIRDUO RESPICLICK, containing active ingredient FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- BLUEPRINT MEDICINES CORP's AYVAKIT, containing active ingredient AVAPRITINIB
- BOEHRINGER INGELHEIM's GILOTRIF, containing active ingredient AFATINIB DIMALEATE
- CEPHALON INC's TRISENOX, containing active ingredient ARSENIC TRIOXIDE


Patents Expiring This Week

AZILSARTAN KAMEDOXOMIL - TABLET;ORAL - EDARBI

From AZURITY PHARMACEUTICALS INC; for treating hypertension


Azilsartan Kamedoxomil


EQ 40MG MEDOXOMIL; EQ 80MG MEDOXOMIL

Approved in Feb 25, 2011, used as Reference Listed Drug

There are 2 future patent(s) for this application. The earliest expires on 2025-05-22, and the latest expires on 2028-03-26.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
7572920 U-3 TREATMENT OF HYPERTENSION 2025-01-07 Benzimidazole derivative and use as a II receptor antagon


AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - TABLET;ORAL - EDARBYCLOR

From AZURITY PHARMACEUTICALS INC; for treating hypertension


Azilsartan KamedoxomilChlorthalidone


EQ 40MG MEDOXOMIL;12.5MG

EQ 40MG MEDOXOMIL;25MG

Approved in Dec 20, 2011, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-05-22, and the latest expires on 2031-07-01.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
7572920 U-3 TREATMENT OF HYPERTENSION 2025-01-07 Benzimidazole derivative and use as a II receptor antagon


CHOLINE FENOFIBRATE - CAPSULE, DELAYED RELEASE;ORAL - TRILIPIX

From ABBVIE INC; for treating high levels of fat or cholesterol in the blood


Choline Fenofibrate


EQ 135MG FENOFIBRIC ACID

Approved in Dec 15, 2008, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No Patent Expiration Date Patent Title
7259186 2025-01-07 Salts of fenofibric acid and pharmaceutical formulations thereof

EQ 45MG FENOFIBRIC ACID

Approved in Dec 15, 2008, used as Reference Listed Drug

There are no future patents for this application.

Patent No Patent Expiration Date Patent Title
7259186 2025-01-07 Salts of fenofibric acid and pharmaceutical formulations thereof


RISPERIDONE - SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - UZEDY

From TEVA NEUROSCIENCE INC; for treating a number of mental health disorders including schizophrenia, bipolar mania, psychosis, or as an adjunct in severe depression


Risperidone


100MG/0.28ML (100MG/0.28ML); 125MG/0.35ML (125MG/0.35ML); 150MG/0.42ML (150MG/0.42ML); 200MG/0.56ML (200MG/0.56ML); 250MG/0.7ML (250MG/0.7ML); 50MG/0.14ML (50MG/0.14ML); 75MG/0.21ML (75MG/0.21ML)

All approved in Apr 28, 2023, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2027-11-12, and the latest expires on 2040-09-11.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
10736965

2025-01-12 Risperidone biodegradable implant
9439905 U-543 TREATMENT OF SCHIZOPHRENIA 2025-01-12 Risperidone-containing implants and methods of use thereof
9895447

2025-01-12 Drug-containing PLA implants and methods of use thereof
9925268

2025-01-12 Drug-containing implants and methods of use thereof
9717799

2025-01-12 Drug-containing implants and methods of use thereof
8802127

2025-01-12 Risperidone-containing PLA:PGA implants and methods of use thereof


Exclusivities Expiring This Week

AFATINIB DIMALEATE - TABLET;ORAL - GILOTRIF

From BOEHRINGER INGELHEIM; for treating locally advanced or metastatic NSCLC with non-resistant EGFR mutations or resistance to platinum-based chemotherapy


Afatinib Dimaleate


EQ 20MG BASE; EQ 30MG BASE

Approved in Jul 12, 2013, used as Reference Listed Drug

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-07, and the latest expires on 2025-10-07.

Exclusivity Date Exclusivity Use Definition
2025-01-12 FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

EQ 40MG BASE

Approved in Jul 12, 2013, used as Reference Listed Drug and Reference Standard

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-07, and the latest expires on 2025-10-07.

Exclusivity Date Exclusivity Use Definition
2025-01-12 FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST


ARSENIC TRIOXIDE - INJECTABLE;INJECTION - TRISENOX

From CEPHALON INC; for treating refractory or relapsed acute promyelocytic leukemia in patients with prior retinoid and anthracycline chemotherapy


Arsenic Trioxide


2MG/ML

Approved in Oct 13, 2017, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date Exclusivity Use Definition
2025-01-12 ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION


AVAPRITINIB - TABLET;ORAL - AYVAKIT

From BLUEPRINT MEDICINES CORP; for treating multidrug resistant gastrointestinal tumors


Avapritinib


100MG; 200MG

Approved in Jan 9, 2020, used as Reference Listed Drug

There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-22, and the latest expires on 2030-05-22.

Exclusivity Date Exclusivity Use Definition
2025-01-09 NEW CHEMICAL ENTITY


25MG; 50MG

Approved in Jun 16, 2021, used as Reference Listed Drug

There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-22, and the latest expires on 2030-05-22.

Exclusivity Date Exclusivity Use Definition
2025-01-09 NEW CHEMICAL ENTITY

300MG

Approved in Jan 9, 2020, used as Reference Listed Drug and Reference Standard

There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-22, and the latest expires on 2030-05-22.

Exclusivity Date Exclusivity Use Definition
2025-01-09 NEW CHEMICAL ENTITY



FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - POWDER;INHALATION - AIRDUO RESPICLICK

From TEVA PHARMACEUTICAL INDUSTRIES LTD; for preventing asthma attacks and flare-ups or worsening of COPD


Fluticasone PropionateSalmeterol Xinafoate


0.055MG/INH;EQ 0.014MG BASE/INH

Approved in Jan 27, 2017, used as Reference Listed Drug

There are no future exclusivities for this application.

Exclusivity Date Exclusivity Use Definition
2025-01-09 PEDIATRIC EXCLUSIVITY