Patent and Exclusivity Expirations Report
Report generated for the week of 2025-04-07 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 9 drugs in the patent and exclusivity list. They are:
Invokana by Janssen Pharmaceuticals, containing active ingredient Canagliflozin
Invokamet by Janssen Pharmaceuticals, containing active ingredient Canagliflozin and Metformin Hydrochloride
Invokamet XR by Janssen Pharmaceuticals, containing active ingredient Canagliflozin and Metformin Hydrochloride
Bydureon BCise by AstraZeneca, containing active ingredient Exenatide Synthetic
Farxiga by AstraZeneca, containing active ingredient Dapagliflozin
Gilotrif by Boehringer Ingelheim, containing active ingredient Afatinib Dimaleate
Dayvigo by Eisai, containing active ingredient Lemborexant
Afinitor Disperz by Novartis, containing active ingredient Everolimus
Koselugo by AstraZeneca, containing active ingredient Selumetinib Sulfate
Patents Expiring This Week
CANAGLIFLOZIN - TABLET;ORAL - INVOKANA
From JANSSEN PHARMACEUTICALS INC; an oral diabetes medicine that helps control blood sugar levels.
100MG
Approved in Mar 29, 2013, used as Reference Listed Drug
300MG
Approved in Mar 29, 2013, used as Reference Listed Drug and Reference Standard
There are 9 future patent(s) for this application. The earliest expires on 2025-10-11, and the latest expires on 2031-11-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8222219 | U-2441 | REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | 2025-04-11 | Glucopyranoside compound |
| 8222219 | U-2632 | REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | 2025-04-11 | Glucopyranoside compound |
| 8222219 | U-493 | TREATMENT OF TYPE 2 DIABETES MELLITUS | 2025-04-11 | Glucopyranoside compound |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - INVOKAMET XR
From JANSSEN PHARMACEUTICALS INC; a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
150MG;1GM
Approved in Sep 20, 2016, used as Reference Listed Drug and Reference Standard
50MG;1GM
50MG;500MG
150MG;500MG
Approved in Sep 20, 2016, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2025-10-11, and the latest expires on 2029-08-26.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8222219 | U-2441 | REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | 2025-04-11 | Glucopyranoside compound |
| 8222219 | U-2632 | REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | 2025-04-11 | Glucopyranoside compound |
| 8222219 | U-493 | TREATMENT OF TYPE 2 DIABETES MELLITUS | 2025-04-11 | Glucopyranoside compound |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - TABLET;ORAL - INVOKAMET
From JANSSEN PHARMACEUTICALS INC; an oral diabetes medicine that helps control blood sugar levels.
150MG;1GM
Approved in Aug 8, 2014, used as Reference Listed Drug and Reference Standard
50MG;1GM
150MG;500MG
50MG;500MG
Approved in Aug 8, 2014, used as Reference Listed Drug
There are 8 future patent(s) for this application. The earliest expires on 2025-10-11, and the latest expires on 2030-07-06.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8222219 | U-493 | TREATMENT OF TYPE 2 DIABETES MELLITUS | 2025-04-11 | Glucopyranoside compound |
| 8222219 | U-2441 | REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | 2025-04-11 | Glucopyranoside compound |
| 8222219 | U-2632 | REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS | 2025-04-11 | Glucopyranoside compound |
DAPAGLIFLOZIN - TABLET;ORAL - FARXIGA
From ASTRAZENECA AB; an oral medication that may be given to certain people with diabetes, heart disease, or kidney disease to improve their outcomes.
10MG
Approved in Jan 8, 2014, used as Reference Listed Drug and Reference Standard
5MG
Approved in Jan 8, 2014, used as Reference Listed Drug
There are 32 future patent(s) for this application. The earliest expires on 2025-06-30, and the latest expires on 2040-09-09.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8431685 | U-2139 | TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-2139 | TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE | 2025-04-13 | Polymer-based sustained release device |
EXENATIDE SYNTHETIC - SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - BYDUREON BCISE
From ASTRAZENECA AB; a GLP-1 agonist used in the management of 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 19 future patent(s) for this application. The earliest expires on 2025-06-30, and the latest expires on 2031-04-04.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8461105 | U-2590 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-3189 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION | 2025-04-13 | Polymer-based sustained release device |
| 7612176 | U-3190 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA | 2025-04-13 | Polymer-based sustained release device |
| 7612176 | U-3188 | IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-3189 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-2588 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-3188 | IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE | 2025-04-13 | Polymer-based sustained release device |
| 7612176 | U-3189 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-3190 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-2590 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-2597 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 7612176 | U-2590 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES | 2025-04-13 | Polymer-based sustained release device |
| 7612176 | U-2589 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-2589 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 8431685 | U-2597 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-2589 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-3190 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-2588 | AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN | 2025-04-13 | Polymer-based sustained release device |
| 8461105 | U-3188 | IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE | 2025-04-13 | Polymer-based sustained release device |
Exclusivities Expiring This Week
AFATINIB DIMALEATE - TABLET;ORAL - GILOTRIF
From BOEHRINGER INGELHEIM; an antineoplastic agent used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with non-resistant EGFR mutations or resistance to platinum-based chemotherapy.
EQ 40MG BASE
Approved in Jul 12, 2013, used as Reference Listed Drug and Reference Standard
EQ 20MG BASE； EQ 30MG BASE
Approved in Jul 12, 2013, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-07-12, and the latest expires on 2025-10-07.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-07 | REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST |
EVEROLIMUS - TABLET, FOR SUSPENSION;ORAL - AFINITOR DISPERZ
From NOVARTIS PHARMACEUTICAL CORP; a mammalian target of rapamycin (mTOR) kinase inhibitor used to treat various types of malignancies.
5MG
Approved in Aug 29, 2012, used as Reference Listed Drug and Reference Standard
2MG; 3MG
Approved in Aug 29, 2012, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-10 | FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES |
LEMBOREXANT - TABLET;ORAL - DAYVIGO
From EISAI INC; a dual orexin antagonist indicated for the treatment of sleep-onset and/or sleep maintenance insomnia.
10MG
Approved in Apr 7, 2020, used as Reference Listed Drug and Reference Standard
5MG
Approved in Apr 7, 2020, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-04-20, and the latest expires on 2026-04-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-07 | NEW CHEMICAL ENTITY |
SELUMETINIB SULFATE - CAPSULE;ORAL - KOSELUGO
From ASTRAZENECA PHARMACEUTICALS LP; a MEK 1/2 inhibitor used in pediatric patients to treat neurofibromatosis type 1 (NF1) accompanied by symptomatic, inoperable plexiform neurofibromas (PN).
EQ 25MG BASE
Approved in Apr 10, 2020, used as Reference Listed Drug and Reference Standard
EQ 10MG BASE
Approved in Apr 10, 2020, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-04-10, and the latest expires on 2027-04-10.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-10 | NEW CHEMICAL ENTITY |
