Patent and Exclusivity Expirations Report
Report generated for the week of 2025-09-22 by Unibest Digital Center. Current analysis scope only include the US FDA.
Visit Unibest Licensing serivce and explore FDF assets open for global licensing and/or technology transfer.
Visit Unibest intermediates and APIs for global supply.
Summary of Expirations
This week, there are 9 drugs in the patent and exclusivity list. They are:
Combogesic by AFT Pharmaceuticals, containing active ingredient Acetaminophen; Ibuprofen
Nuplazid by Acadia Pharmaceuticals, containing active ingredient Pimavanserin Tartrate
Tasigna by Novartis Pharmaceuticals, containing active ingredient Nilotinib Hydrochloride
Copiktra by Secura Bio, containing active ingredient Duvelisib
Fintepla by UCB, containing active ingredient Fenfluramine Hydrochloride
Vizimpro by Pfizer, containing active ingredient Dacomitinib
Iheezo by Harrow Eye, containing active ingredient Chloroprocaine Hydrochloride
Epidiolex by Jazz Pharmaceuticals, containing active ingredient Cannabidiol
Arikayce Kit by Insmed, containing active ingredient Amikacin Sulfate
Patents Expiring This Week
ACETAMINOPHEN; IBUPROFEN - TABLET;ORAL - COMBOGESIC
From AFT PHARMACEUTICALS US INC; used in adults for the short-term management of mild to moderate acute pain.
325MG;97.5MG
Approved in Mar 1, 2023, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2039-02-27, and the latest expires on 2039-02-27.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 10532036 | U-3553 | A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION | 2025-09-22 | Combination composition |
PIMAVANSERIN TARTRATE - CAPSULE;ORAL - NUPLAZID
From ACADIA PHARMACEUTICALS INC; used to treat hallucinations and delusions in people with psychosis related to Parkinson's disease.
EQ 34MG BASE
Approved in Jun 28, 2018, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2026-08-24, and the latest expires on 2038-08-27.
| Patent No | Patent Expiration Date | Patent Title |
| 7923564 | 2025-09-26 | Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N′-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms |
PIMAVANSERIN TARTRATE - TABLET;ORAL - NUPLAZID
From ACADIA PHARMACEUTICALS INC; used to treat hallucinations and delusions in people with psychosis related to Parkinson's disease.
EQ 10MG BASE
Approved in Jun 28, 2018, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2026-08-24, and the latest expires on 2037-03-23.
| Patent No | Patent Expiration Date | Patent Title |
| 7923564 | 2025-09-26 | Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N′-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms |
Exclusivities Expiring This Week
AMIKACIN SULFATE - SUSPENSION, LIPOSOMAL;INHALATION - ARIKAYCE KIT
From INSMED INC; a prescription antibiotic medicine that is used for difficult-to-treat Mycobacterium avium complex (MAC) lung disease in adults who have few or no other treatment options.
EQ 590MG BASE/8.4ML
Approved in Sep 28, 2018, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2030-09-28, and the latest expires on 2030-09-28.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-28 | TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY |
CANNABIDIOL - SOLUTION;ORAL - EPIDIOLEX
From JAZZ PHARMACEUTICALS RESEARCH UK LTD; a prescription antibiotic medicine that is used for difficult-to-treat Mycobacterium avium complex (MAC) lung disease in adults who have few or no other treatment options.
100MG/ML
Approved in Sep 28, 2018, used as Reference Listed Drug and Reference Standard
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-10-20, and the latest expires on 2027-07-31.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-28 | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER |
CHLOROPROCAINE HYDROCHLORIDE - GEL;OPHTHALMIC - IHEEZO
From HARROW EYE LLC; used in adults to numb the eyes for a planned procedure.
3%
Approved in Sep 27, 2022, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-27 | NEW PRODUCT |
DACOMITINIB - TABLET;ORAL - VIZIMPRO
From PFIZER INC; a prescription medicine used to treat non-small cell lung cancer that has spread to other parts of the body (metastasised).
45MG
Approved in Sep 27, 2018, used as Reference Listed Drug and Reference Standard
15MG; 30MG
Approved in Sep 27, 2018, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-27 | INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST |
| 2025-09-27 | FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST |
DUVELISIB - CAPSULE;ORAL - COPIKTRA
From SECURA BIO INC; used to treat adults with chronic lymphocytic leukemia or small lymphocytic leukemia.
15MG; 25MG
Approved in Sep 24, 2018, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-24 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES |
FENFLURAMINE HYDROCHLORIDE - SOLUTION;ORAL - FINTEPLA
From UCB INC; used to treat the seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
EQ 2.2MG BASE/ML
Approved in Jun 25, 2020, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2027-06-25, and the latest expires on 2029-09-25.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-25 | PEDIATRIC EXCLUSIVITY |
NILOTINIB HYDROCHLORIDE - CAPSULE;ORAL - TASIGNA
From NOVARTIS PHARMACEUTICALS CORP; used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML) in adults and children who are at least 1 year old.
EQ 200MG BASE
Approved in Oct 29, 2007, used as Reference Listed Drug and Reference Standard
EQ 150MG BASE
Approved in Jun 17, 2010, used as Reference Listed Drug
EQ 50MG BASE
Approved in Mar 22, 2018, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2028-09-23, and the latest expires on 2029-03-23.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-22 | PEDIATRIC EXCLUSIVITY |
