Patent and Exclusivity Expirations Report
Report generated for the week of 2025-03-10 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 16 drugs in the patent and exclusivity list. They are:
Yupelri by Mylan Ireland Ltd, containing active ingredient Revefenacin
Xiidra by Bausch and Lomb Inc, containing active ingredient Lifitegrast
Ogsiveo by Springworks Therapeutics Inc, containing active ingredient Nirogacestat Hydrobromide
Koselugo by AstraZeneca Pharmaceuticals LP, containing active ingredient Selumetinib Sulfate
Mektovi by Array Biopharma Inc, containing active ingredient Binimetinib
Viberzi by AbbVie Inc, containing active ingredient Eluxadoline
Abilify Maintena Kit by Otsuka Pharmaceutical Co Ltd, containing active ingredient Aripiprazole
Oseni by Takeda Pharmaceuticals USA Inc, containing active ingredient Alogliptin Benzoate; Pioglitazone Hydrochloride
Nesina by Takeda Pharmaceuticals USA Inc, containing active ingredient Alogliptin Benzoate
Kazano by Takeda Pharmaceuticals USA Inc, containing active ingredient Alogliptin Benzoate; Metformin Hydrochloride
Abilify Asimtufii by Otsuka Pharmaceutical Co Ltd, containing active ingredient Aripiprazole
Lumigan by AbbVie Inc, containing active ingredient Bimatoprost
Xcopri by SK Life Science Inc, containing active ingredient Cenobamate
Adlarity by Corium LLC, containing active ingredient Donepezil Hydrochloride
Lynparza by AstraZeneca Pharmaceuticals LP, containing active ingredient Olaparib
Rinvoq by AbbVie Inc, containing active ingredient Upadacitinib
Patents Expiring This Week
ALOGLIPTIN BENZOATE - TABLET;ORAL - NESINA
From TAKEDA PHARMACEUTICALS USA INC; to improve blood sugar control in adults with type 2 diabetes mellitus.
EQ 12.5MG BASE; EQ 6.25MG BASE
Approved in Jan 25, 2013, used as Reference Listed Drug
EQ 25MG BASE
Approved in Jan 25, 2013, used as Reference Listed Drug and Reference Standard
There are 3 future patent(s) for this application. The earliest expires on 2025-12-02, and the latest expires on 2029-06-16.
| Patent No | Patent Expiration Date | Patent Title |
| 8288539 | 2025-03-15 | Dipeptidyl peptidase inhibitors |
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - TABLET;ORAL - KAZANO
From TAKEDA PHARMACEUTICALS USA INC; to improve blood sugar control in adults with type 2 diabetes mellitus.
EQ 12.5MG BASE;1GM
Approved in Jan 25, 2013, used as Reference Listed Drug and Reference Standard
EQ 12.5MG BASE;500MG
Approved in Jan 25, 2013, used as Reference Listed Drug
There are 3 future patent(s) for this application. The earliest expires on 2025-06-24, and the latest expires on 2029-05-24.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8173663 | U-1338 | METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN | 2025-03-15 | Dipeptidyl peptidase inhibitors |
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - TABLET;ORAL - OSENI
From TAKEDA PHARMACEUTICALS USA INC; to improve blood sugar control in adults with type 2 diabetes mellitus.
EQ 25MG BASE;EQ 45MG BASE
Approved in Jan 25, 2013, used as Reference Listed Drug and Reference Standard
EQ 12.5MG BASE;EQ 30MG BASE
EQ 25MG BASE;EQ 15MG BASE
EQ 25MG BASE;EQ 30MG BASE
Approved in Jan 25, 2013, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2028-06-27, and the latest expires on 2029-06-04.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8173663 | U-1338 | METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN | 2025-03-15 | Dipeptidyl peptidase inhibitors |
| 8288539 |
|
| 2025-03-15 | Dipeptidyl peptidase inhibitors |
ARIPIPRAZOLE - FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - ABILIFY MAINTENA KIT
From OTSUKA PHARMACEUTICAL CO LTD; to treat a wide variety of mood and psychotic disorders, such as schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's syndrome.
300MG; 300MG/VIAL; 400MG
Approved in Sep 29, 2014, used as Reference Listed Drug
400MG/VIAL
Approved in Feb 28, 2013, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2025-06-29, and the latest expires on 2034-04-06.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8338427 | U-1633 | USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA | 2025-03-15 | Methods for administering aripiprazole |
| 8338427 | U-543 | TREATMENT OF SCHIZOPHRENIA | 2025-03-15 | Methods for administering aripiprazole |
ARIPIPRAZOLE - SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - ABILIFY ASIMTUFII
From OTSUKA PHARMACEUTICAL CO LTD; to treat a wide variety of mood and psychotic disorders, such as schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's syndrome.
720MG/2.4ML (300MG/ML)
Approved in Apr 27, 2023, used as Reference Listed Drug
960MG/3.2ML (300MG/ML)
Approved in Apr 27, 2023, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2025-06-29, and the latest expires on 2033-04-23.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8338427 | U-1530 | USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION | 2025-03-15 | Methods for administering aripiprazole |
BIMATOPROST - SOLUTION/DROPS;OPHTHALMIC - LUMIGAN
From ABBVIE INC; to treat hypotrichosis of the eyelashes and intraocular pressure in open angle glaucoma or ocular hypertension.
0.01%
Approved in Aug 31, 2010, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2027-06-13, and the latest expires on 2027-06-13.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8933127 |
|
| 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8278353 |
|
| 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8309605 | U-1293 | A METHOD OF LOWERING INTRAOCULAR PRESSURE IN A PATIENT WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8299118 | U-1295 | A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 9241918 | U-1814 | METHOD OF TREATING GLAUCOMA OR ELEVATED INTRAOCULAR PRESSURE | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8772338 | U-1528 | A METHOD OF LOWERING INTRAOCULAR PRESSURE | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8338479 | U-1295 | A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8933120 |
|
| 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8309605 | U-1294 | METHOD OF TREATING GLAUCOMA IN A PATIENT | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 9155716 | U-1528 | A METHOD OF LOWERING INTRAOCULAR PRESSURE | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8524777 | U-1235 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
| 8586630 | U-1458 | A METHOD OF REDUCING INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION | 2025-03-16 | Enhanced bimatoprost ophthalmic solution |
BINIMETINIB - TABLET;ORAL - MEKTOVI
From ARRAY BIOPHARMA INC; to treat metastatic melanoma with specific mutations.
15MG
Approved in Jun 27, 2018, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2030-08-27, and the latest expires on 2033-10-18.
| Patent No | Patent Expiration Date | Patent Title |
| 7777050 | 2025-03-13 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
ELUXADOLINE - TABLET;ORAL - VIBERZI
From ABBVIE INC; to treat irritable bowel syndrome with diarrhea.
100MG
Approved in May 27, 2015, used as Reference Listed Drug and Reference Standard
75MG
Approved in May 27, 2015, used as Reference Listed Drug
There are 14 future patent(s) for this application. The earliest expires on 2028-07-07, and the latest expires on 2033-03-14.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9700542 |
|
| 2025-03-14 | Compounds as opioid receptor modulators |
| 8609709 |
|
| 2025-03-14 | Compounds as opioid receptor modulators |
| 7786158 |
|
| 2025-03-14 | Compounds as opioid receptor modulators |
| 8344011 | U-1709 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). | 2025-03-14 | Compounds as opioid receptor modulators |
| 8772325 | U-1709 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). | 2025-03-14 | Compounds as opioid receptor modulators |
| 9205076 | U-1709 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). | 2025-03-14 | Compounds as opioid receptor modulators |
| 10213415 | U-2152 | TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE) | 2025-03-14 | Compounds as opioid receptor modulators |
LIFITEGRAST - SOLUTION/DROPS;OPHTHALMIC - XIIDRA
From BAUSCH AND LOMB INC; to treat dry eye disease.
5%
Approved in Jul 11, 2016, used as Reference Listed Drug and Reference Standard
There are 10 future patent(s) for this application. The earliest expires on 2026-05-17, and the latest expires on 2033-12-18.
| Patent No | Patent Expiration Date | Patent Title |
| 7314938 | 2025-03-10 | Modulators of cellular adhesion |
NIROGACESTAT HYDROBROMIDE - TABLET;ORAL - OGSIVEO
From SPRINGWORKS THERAPEUTICS INC; to treat desmoid tumors
EQ 100MG BASE
Approved in Apr 4, 2024, used as Reference Listed Drug
EQ 150MG BASE
Approved in Apr 4, 2024, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE
Approved in Nov 27, 2023, used as Reference Listed Drug
There are 26 future patent(s) for this application. The earliest expires on 2025-08-18, and the latest expires on 2043-05-19.
| Patent No | Patent Expiration Date | Patent Title |
| 7951958 | 2025-03-11 | Imidazole compounds for the treatment of neurodegenerative disorders |
REVEFENACIN - SOLUTION;INHALATION - YUPELRI
From MYLAN IRELAND LTD; to treat COPD
175MCG/3ML
Approved in Nov 9, 2018, used as Reference Listed Drug and Reference Standard
There are 9 future patent(s) for this application. The earliest expires on 2028-10-31, and the latest expires on 2039-10-23.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8053448 | U-2440 | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 10343995 | U-2440 | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 7585879 | U-2440 | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 8273894 |
|
| 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 11247969 |
|
| 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 7521041 | U-2440 | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 7491736 | U-2440 | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 8034946 |
|
| 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 7910608 |
|
| 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 7550595 |
|
| 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
| 10106503 | U-2440 | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | 2025-03-10 | Biphenyl compounds useful as muscarinic receptor antagonists |
SELUMETINIB SULFATE - CAPSULE;ORAL - KOSELUGO
From ASTRAZENECA PHARMACEUTICALS LP; to treat neurofibromatosis type 1 (NF1) accompanied by symptomatic, inoperable plexiform neurofibromas (PN).
EQ 10MG BASE
Approved in Apr 10, 2020, used as Reference Listed Drug
EQ 25MG BASE
Approved in Apr 10, 2020, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2026-03-13, and the latest expires on 2029-03-26.
| Patent No | Patent Expiration Date | Patent Title |
| 8178693 | 2025-03-13 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Exclusivities Expiring This Week
CENOBAMATE - TABLET;ORAL - XCOPRI
From SK LIFE SCIENCE INC; to treat partial onset seizures in adults.
200MG; 150MG; 100MG; ; 50MG; 25MG
Approved in Mar 10, 2020, used as Reference Listed Drug
12.5MG
Approved in Mar 10, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-03-10 | NEW CHEMICAL ENTITY |
DONEPEZIL HYDROCHLORIDE - SYSTEM;TRANSDERMAL - ADLARITY
From CORIUM LLC; to treat the behavioral and cognitive effects of Alzheimer's Disease and other types of dementia.
10MG/DAY
Approved in Mar 11, 2022, used as Reference Listed Drug and Reference Standard
5MG/DAY
Approved in Mar 11, 2022, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-03-11 | NEW PRODUCT |
OLAPARIB - TABLET;ORAL - LYNPARZA
From ASTRAZENECA PHARMACEUTICALS LP; to treat ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.
Unibest is offering Olaparib Form B for generic development.
100MG
Approved in Aug 17, 2017, used as Reference Listed Drug
150MG
Approved in Aug 17, 2017, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2025-12-19, and the latest expires on 2027-05-08.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-03-11 | FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
UPADACITINIB - TABLET, EXTENDED RELEASE;ORAL - RINVOQ
From ABBVIE INC; to treat moderate to severe rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, and severe atopic dermatitis, including in patients who did not respond well to other therapies.
15MG
Approved in Aug 16, 2019, used as Reference Listed Drug
30MG
Approved in Jan 14, 2022, used as Reference Listed Drug
45MG
Approved in Mar 16, 2022, used as Reference Listed Drug and Reference Standard
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-29, and the latest expires on 2031-04-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-03-16 | TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
