Patent and Exclusivity Expirations Report
Report generated for the week of 2025-08-04 by Unibest Digital Center. Current analysis scope only include the US FDA.
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Summary of Expirations
This week, there are 9 drugs in the patent and exclusivity list. They are:
Sprycel by Bristol Myers Squibb Co, containing active ingredient Dasatinib
Zydelig by Gilead Sciences Inc, containing active ingredient Idelalisib
Myfembree by Sumitomo Pharma Switzerland GmbH, containing active ingredient Estradiol; Norethindrone Acetate; Relugolix
Nubeqa by Bayer Healthcare Pharmaceuticals Inc, containing active ingredient Darolutamide
Lampit by Bayer Healthcare Pharmaceuticals Inc, containing active ingredient Nifurtimox
Orkambi by Vertex Pharmaceuticals Inc, containing active ingredient Ivacaftor; Lumacaftor
Evrysdi by Genentech Inc, containing active ingredient Risdiplam
Onpattro by Alnylam Pharmaceuticals Inc, containing active ingredient Patisiran Sodium
Galafold by Amicus Therapeutics US LLC, containing active ingredient Migalastat Hydrochloride
Patents Expiring This Week
DASATINIB - TABLET;ORAL - SPRYCEL
From BRISTOL MYERS SQUIBB CO; a tyrosine kinase inhibitor used for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia.
100MG
Approved in May 30, 2008, used as Reference Listed Drug and Reference Standard
20MG; 50MG; 70MG
Approved in Jun 28, 2006, used as Reference Listed Drug
80MG; 140MG
Approved in Oct 28, 2010, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2026-03-28, and the latest expires on 2026-09-28.
| Patent No | Patent Expiration Date | Patent Title |
| 8680103*PED | 2025-08-04 | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
IDELALISIB - TABLET;ORAL - ZYDELIG
From GILEAD SCIENCES INC; an antineoplastic kinase inhibitor used to treat chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL).
150MG
Approved in Jul 23, 2014, used as Reference Listed Drug and Reference Standard
100MG
Approved in Jul 23, 2014, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2030-03-11, and the latest expires on 2033-09-02.
| Patent No | Patent Expiration Date | Patent Title |
| RE44638 | 2025-08-05 | Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta |
Exclusivities Expiring This Week
DAROLUTAMIDE - TABLET;ORAL - NUBEQA
From BAYER HEALTHCARE PHARMACEUTICALS INC; an androgen receptor antagonist used for castration-resistant, non-metastatic prostate cancer and metastatic hormone-sensitive prostate cancer.
300MG
Approved in Jul 30, 2019, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-05 | TREATMENT OF ADULT PATIENTS WITH METASTATIC HORMONE©\SENSITIVE PROSTATE CANCER (MHSPC) IN COMBINATION WITH DOCETAXEL |
ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX - TABLET;ORAL - MYFEMBREE
From SUMITOMO PHARMA SWITZERLAND GMBH; used in premenopausal women to control heavy menstrual bleeding due to uterine fibroids, and also in premenopausal women to manage moderate to severe pain associated with endometriosis.
1MG;0.5MG;40MG
Approved in May 26, 2021, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-12-18, and the latest expires on 2026-01-27.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-05 | FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
IVACAFTOR; LUMACAFTOR - GRANULE;ORAL - ORKAMBI
From VERTEX PHARMACEUTICALS INC; used to treat certain types of cystic fibrosis in adults and children 1 year of age and older.
188MG/PACKET;150MG/PACKET
Approved in Aug 7, 2018, used as Reference Listed Drug and Reference Standard
125MG/PACKET;100MG/PACKET
Approved in Aug 7, 2018, used as Reference Listed Drug
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-09-02, and the latest expires on 2030-03-02.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-07 | FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE |
MIGALASTAT HYDROCHLORIDE - CAPSULE;ORAL - GALAFOLD
From AMICUS THERAPEUTICS US LLC; used to treat Fabry disease in adults.
EQ 123MG BASE
Approved in Aug 10, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-10 | INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA |
NIFURTIMOX - TABLET;ORAL - LAMPIT
From BAYER HEALTHCARE PHARMACEUTICALS INC; an antiparasitic drug used for the treatment of Chagas disease (Trypanosoma cruzi infection).
120MG
Approved in Aug 6, 2020, used as Reference Listed Drug and Reference Standard
30MG
Approved in Aug 6, 2020, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-08-06, and the latest expires on 2027-08-06.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-06 | NEW CHEMICAL ENTITY |
PATISIRAN SODIUM - SOLUTION;INTRAVENOUS - ONPATTRO
From ALNYLAM PHARMACEUTICALS INC; a transthyretin-directed small interfering RNA used to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis.
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approved in Aug 10, 2018, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-01-13, and the latest expires on 2026-01-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-10 | INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS |
RISDIPLAM - FOR SOLUTION;ORAL - EVRYSDI
From GENENTECH INC; an oral mRNA splicing modifier used in the treatment of spinal muscular atrophy (SMA).
0.75MG/ML
Approved in Aug 7, 2020, used as Reference Listed Drug and Reference Standard
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-10-03, and the latest expires on 2029-05-27.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-07 | NEW CHEMICAL ENTITY |
RISDIPLAM - TABLET;ORAL - EVRYSDI
From GENENTECH INC; an oral mRNA splicing modifier used in the treatment of spinal muscular atrophy (SMA).
5MG
Approved in Feb 11, 2025, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-10-03, and the latest expires on 2026-10-03.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-07 | NEW CHEMICAL ENTITY |
