Patent and Exclusivity Expirations Report
Report generated for the week of 2025-06-16 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:
Pomalyst by Bristol Myers Squibb Co, containing active ingredient Pomalidomide
Tobi Podhaler by Viatris Specialty LLC, containing active ingredient Tobramycin
Imcivree by Rhythm Pharmaceuticals Inc, containing active ingredient Setmelanotide Acetate
Bosulif by PF Prism CV, containing active ingredient Bosutinib Monohydrate
Xarelto by Janssen Pharmaceuticals Inc, containing active ingredient Rivaroxaban
Ablysinol by BPI Labs LLC, containing active ingredient Alcohol
Procysbi by Horizon Therapeutics USA Inc, containing active ingredient Cysteamine Bitartrate
Tafinlar by Novartis Pharmaceuticals Corp, containing active ingredient Dabrafenib Mesylate
Mekinist by Novartis Pharmaceuticals Corp, containing active ingredient Trametinib Dimethyl Sulfoxide
Patents Expiring This Week
POMALIDOMIDE - CAPSULE;ORAL - POMALYST
From BRISTOL MYERS SQUIBB CO; a thalidomide analogue used in combination with dexamethasone to treat patients with multiple myeloma.
4MG
Approved in Feb 8, 2013, used as Reference Listed Drug and Reference Standard
1MG; 2MG; 3MG
Approved in Feb 8, 2013, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2031-12-21.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8198262 | U-2254 | USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY | 2025-06-17 | Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
| 8198262 | U-1360 | USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA | 2025-06-17 | Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
TOBRAMYCIN - POWDER;INHALATION - TOBI PODHALER
From VIATRIS SPECIALTY LLC; an aminoglycoside antibiotic used to treat cystic fibrosis-associated bacterial, lower respiratory tract, urinary tract, eye, skin, bone, and skin structure infections.
28MG
Approved in Mar 22, 2013, used as Reference Listed Drug and Reference Standard
There are 3 future patent(s) for this application. The earliest expires on 2025-10-27, and the latest expires on 2030-11-04.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8664187 | U-909 | TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA | 2025-06-20 | Methods of treatment of endobronchial infections |
Exclusivities Expiring This Week
ALCOHOL - SOLUTION;INTRA-ARTERIAL - ABLYSINOL
From BPI LABS LLC
99% (5ML)
Approved in Jun 21, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-21 | INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY |
BOSUTINIB MONOHYDRATE - TABLET;ORAL - BOSULIF
From PF PRISM CV; an antineoplastic agent used for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adults with inadequate clinical response to other treatments.
Click to explore Bosutinib intermediates.
EQ 100MG BASE
Approved in Sep 4, 2012, used as Reference Listed Drug and Reference Standard
EQ 500MG BASE
Approved in Sep 4, 2012, used as Reference Listed Drug
EQ 400MG BASE
Approved in Oct 27, 2017, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-09-26, and the latest expires on 2031-03-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-19 | PEDIATRIC EXCLUSIVITY |
CYSTEAMINE BITARTRATE - CAPSULE, DELAYED RELEASE;ORAL - PROCYSBI
From HORIZON THERAPEUTICS USA INC; a cystine depleting agent used to treat the effects of cystinosis.
EQ 75MG BASE
Approved in Apr 30, 2013, used as Reference Listed Drug and Reference Standard
EQ 25MG BASE
Approved in Apr 30, 2013, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-22 | PEDIATRIC EXCLUSIVITY |
CYSTEAMINE BITARTRATE - GRANULE, DELAYED RELEASE;ORAL - PROCYSBI
From HORIZON THERAPEUTICS USA INC; a cystine depleting agent used to treat the effects of cystinosis.
EQ 75MG BASE/PACKET
Approved in Feb 14, 2020, used as Reference Listed Drug
EQ 300MG BASE/PACKET
Approved in Feb 14, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-22 | PEDIATRIC EXCLUSIVITY |
DABRAFENIB MESYLATE - CAPSULE;ORAL - TAFINLAR
From NOVARTIS PHARMACEUTICALS CORP; a kinase inhibitor used to treat patients with specific types of melanoma, non-small cell lung cancer, and thyroid cancer.
EQ 75MG BASE
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE
Approved in May 29, 2013, used as Reference Listed Drug
There are 7 future exclusivity(ies) for this drug product. The earliest expires on 2025-10-30, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-22 | DABRAFENIB IS INDICATED IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
RIVAROXABAN - FOR SUSPENSION;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC; a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). May also be used as thrombosis prophylaxis in specific situations.
1MG/ML
Approved in Dec 20, 2021, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-20 | PEDIATRIC EXCLUSIVITY |
SETMELANOTIDE ACETATE - SOLUTION;SUBCUTANEOUS - IMCIVREE
From RHYTHM PHARMACEUTICALS INC; a drug indicated to treat obesity caused by genetic POMC, PCSK1, or LEPR deficiencies or Bardet-Biedl syndrome.
EQ 10MG BASE/ML (EQ 10MG BASE/ML)
Approved in Nov 25, 2020, used as Reference Listed Drug and Reference Standard
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-11-25, and the latest expires on 2031-12-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-16 | CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH BARDET-BIEDL SYNDROME (BBS) |
TRAMETINIB DIMETHYL SULFOXIDE - TABLET;ORAL - MEKINIST
From NOVARTIS PHARMACEUTICALS CORP; a kinase inhibitor used alone or in combination with dabrafenib to treat patients with cancers with specific BRAF mutations, such as melanoma and non-small cell lung cancer.
EQ 2MG
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
EQ 0.5MG
Approved in May 29, 2013, used as Reference Listed Drug
There are 7 future exclusivity(ies) for this drug product. The earliest expires on 2025-10-30, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-22 | TRAMETINIB IS INDICATED IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
