Patent and Exclusivity Expirations Report
Report generated for the week of 2025-07-14 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:
Entresto by Novartis Pharmaceuticals Corp, containing active ingredient Sacubitril; Valsartan
Diacomit by Biocodex SA, containing active ingredient Stiripentol
Xalkori by PF Prism CV, containing active ingredient Crizotinib
Opzelura by Incyte Corp, containing active ingredient Ruxolitinib Phosphate
Tibsovo by Servier Pharmaceuticals LLC, containing active ingredient Ivosidenib
Krintafel by GlaxoSmithKline Intellectual Property Development Ltd England, containing active ingredient Tafenoquine Succinate
Patents Expiring This Week
SACUBITRIL; VALSARTAN - TABLET;ORAL - ENTRESTO
From NOVARTIS PHARMACEUTICALS CORP; used to treat adults with chronic heart failure to help reduce the risk of death and hospitalization and to treat certain children aged 1 year and older who have symptomatic heart failure.
97MG;103MG
Approved in Jul 7, 2015, used as Reference Listed Drug and Reference Standard
24MG;26MG
49MG;51MG
Approved in Jul 7, 2015, used as Reference Listed Drug
There are 8 future patent(s) for this application. The earliest expires on 2026-11-08, and the latest expires on 2036-05-09.
| Patent No | Patent Expiration Date | Patent Title |
| 8101659*PED | 2025-07-15 | Methods of treatment and pharmaceutical composition |
Exclusivities Expiring This Week
CRIZOTINIB - CAPSULE, PELLETS;ORAL - XALKORI
From PF PRISM CV; a receptor tyrosine kinase inhibitor used to treat metastatic non-small cell lung cancer (NSCLC) where the tumors have been confirmed to be anaplastic lymphoma kinase (ALK), or ROS1-positive.
150MG
Approved in Sep 7, 2023, used as Reference Listed Drug and Reference Standard
20MG; 50MG
Approved in Sep 7, 2023, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-14 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE |
CRIZOTINIB - CAPSULE;ORAL - XALKORI
From PF PRISM CV; a receptor tyrosine kinase inhibitor used to treat metastatic non-small cell lung cancer (NSCLC) where the tumors have been confirmed to be anaplastic lymphoma kinase (ALK), or ROS1-positive.
250MG
Approved in Aug 26, 2011, used as Reference Listed Drug and Reference Standard
200MG
Approved in Aug 26, 2011, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2028-01-14, and the latest expires on 2029-07-14.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-14 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE |
IVOSIDENIB - TABLET;ORAL - TIBSOVO
From SERVIER PHARMACEUTICALS LLC; an isocitrate dehydrogenase-1 inhibitor used to treat acute myeloid leukemia and cholangiocarcinoma in adults with a susceptible IDH1 mutation.
250MG
Approved in Jul 20, 2018, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-02, and the latest expires on 2030-10-24.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-20 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
RUXOLITINIB PHOSPHATE - CREAM;TOPICAL - OPZELURA
From INCYTE CORP; a kinase inhibitor 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 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-01-18, and the latest expires on 2026-01-18.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-18 | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
STIRIPENTOL - CAPSULE;ORAL - DIACOMIT
From BIOCODEX SA; an antiepileptic agent used in combination with other anticonvulsants to treat seizures associated with Dravet syndrome.
500MG
Approved in Aug 20, 2018, used as Reference Listed Drug and Reference Standard
250MG
Approved in Aug 20, 2018, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-20, and the latest expires on 2029-07-14.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-14 | REVISIONS TO THE LABELING TO PROVIDE FOR THE EXPANSION OF THE USE OF STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS TAKING CLOBAZAM TO INCLUDE PEDIATRIC PATIENTS WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE |
STIRIPENTOL - FOR SUSPENSION;ORAL - DIACOMIT
From BIOCODEX SA; an antiepileptic agent used in combination with other anticonvulsants to treat seizures associated with Dravet syndrome.
500MG/PACKET
Approved in Aug 20, 2018, used as Reference Listed Drug and Reference Standard
250MG/PACKET
Approved in Aug 20, 2018, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-20, and the latest expires on 2029-07-14.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-14 | NEW PATIENT POPULATION |
TAFENOQUINE SUCCINATE - TABLET;ORAL - KRINTAFEL
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; an antiparasitic agent used for the treatment and prevention of relapse of Vivax malaria.
EQ 150MG BASE
Approved in Jul 20, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-20 | INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION |
