Patent and Exclusivity Expirations Report
Report generated for the week of 2025-05-26 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 11 drugs in the patent and exclusivity list. They are:
Spiriva Respimat by Boehringer Ingelheim Pharmaceuticals, containing active ingredient Tiotropium Bromide
Combivent Respimat by Boehringer Ingelheim Pharmaceuticals, containing active ingredient Albuterol Sulfate and Ipratropium Bromide
Stiolto Respimat by Boehringer Ingelheim Pharmaceuticals, containing active ingredient Olodaterol Hydrochloride and Tiotropium Bromide
Striverdi Respimat by Boehringer Ingelheim Pharmaceuticals, containing active ingredient Olodaterol Hydrochloride
Onpattro by Alnylam Pharmaceuticals, containing active ingredient Patisiran Sodium
Folotyn by Acrotech Biopharma, containing active ingredient Pralatrexate
Winlevi by Sun Pharmaceutical Industries, containing active ingredient Clascoterone
Xifaxan by Salix Pharmaceuticals, containing active ingredient Rifaximin
Diprivan by Fresenius Kabi USA, containing active ingredient Propofol
Artesunate by Amivas, containing active ingredient Artesunate
Evrysdi by Genentech, containing active ingredient Risdiplam
Patents Expiring This Week
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - SPRAY, METERED;INHALATION - COMBIVENT RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; used to prevent bronchospasm in people with chronic obstructive pulmonary disease (COPD) who are also using other medicines to control their condition.
EQ 0.1MG BASE/INH;0.02MG/INH
Approved in Oct 7, 2011, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2026-10-10, and the latest expires on 2030-10-16.
| Patent No | Patent Expiration Date | Patent Title |
| 7896264 | 2025-05-26 | Microstructured high pressure nozzle with built-in filter function |
CLASCOTERONE - CREAM;TOPICAL - WINLEVI
From SUN PHARMACEUTICAL INDUSTRIES LTD; for acne vulgaris treatment.
1%
Approved in Aug 26, 2020, used as Reference Listed Drug and Reference Standard
There are 8 future patent(s) for this application. The earliest expires on 2025-07-24, and the latest expires on 2030-07-25.
| Patent No | Patent Expiration Date | Patent Title |
| 9211295 | 2025-05-31 | 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents |
OLODATEROL HYDROCHLORIDE - SPRAY, METERED;INHALATION - STRIVERDI RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; used to control the symptoms of COPD, including chronic bronchitis and emphysema.
EQ 0.0025MG BASE/INH
Approved in Jul 31, 2014, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2026-10-10, and the latest expires on 2030-10-16.
| Patent No | Patent Expiration Date | Patent Title |
| 7896264 | 2025-05-26 | Microstructured high pressure nozzle with built-in filter function |
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - SPRAY, METERED;INHALATION - STIOLTO RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; used to prevent airflow obstruction and reduce flare-ups in adults with COPD, including bronchitis and emphysema.
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Approved in May 21, 2015, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2026-10-10, and the latest expires on 2030-10-16.
| Patent No | Patent Expiration Date | Patent Title |
| 7896264 | 2025-05-26 | Microstructured high pressure nozzle with built-in filter function |
PATISIRAN SODIUM - SOLUTION;INTRAVENOUS - ONPATTRO
From ALNYLAM PHARMACEUTICALS INC; an injectable transthyretin-directed small interfering RNA that may be used to treat polyneuropathy (multiple nerve damage) caused by hereditary transthyretin-mediated amyloidosis (ATTR) in adults.
A, adenosine; C, cytidine; G, guanosine; U, uridine; Cm, 2'-O-methylcytidine; Um, 2'-O-methyluridine; dT, thymidine
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approved in Aug 10, 2018, used as Reference Listed Drug and Reference Standard
There are 13 future patent(s) for this application. The earliest expires on 2027-10-03, and the latest expires on 2035-08-27.
| Patent No | Patent Expiration Date | Patent Title |
| 8334373 | 2025-05-27 | Nuclease resistant double-stranded ribonucleic acid |
PRALATREXATE - SOLUTION;INTRAVENOUS - FOLOTYN
From ACROTECH BIOPHARMA INC; used to treat T-cell lymphoma that has spread throughout the body.
40MG/2ML (20MG/ML)
Approved in Sep 24, 2009, used as Reference Listed Drug and Reference Standard
20MG/ML (20MG/ML)
Approved in Sep 24, 2009, used as Reference Listed Drug
There are no future patents for this application.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7622470 | U-1015 | TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA | 2025-05-31 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin |
| 8299078 | U-1004 | TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA | 2025-05-31 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin |
PROPOFOL - INJECTABLE;INJECTION - DIPRIVAN
From FRESENIUS KABI USA LLC; used in general anesthesia and for sedation.
10MG/ML
Approved in Jun 11, 1996, used as Reference Listed Drug and Reference Standard
There are no future patents for this application.
| Patent No | Patent Expiration Date | Patent Title |
| 8476010*PED | 2025-06-01 | Propofol formulations with non-reactive container closures |
RIFAXIMIN - TABLET;ORAL - XIFAXAN
From SALIX PHARMACEUTICALS INC; used to treat various bacterial infections in the stomach and liver, including traveler's diarrhea and irritable bowel syndrome.
200MG
Approved in May 25, 2004, used as Reference Listed Drug and Reference Standard
550MG
Approved in Mar 24, 2010, used as Reference Listed Drug and Reference Standard
There are 20 future patent(s) for this application. The earliest expires on 2026-02-27, and the latest expires on 2029-10-02.
| Patent No | Patent Expiration Date | Patent Title |
| 7906542 | 2025-06-01 | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
TIOTROPIUM BROMIDE - SPRAY, METERED;INHALATION - SPIRIVA RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; a long-acting bronchodilator used in the management of COPD.
EQ 0.0025MG BASE/INH
Approved in Sep 24, 2014, used as Reference Listed Drug and Reference Standard
EQ 0.00125MG BASE/INH
Approved in Sep 15, 2015, used as Reference Listed Drug and Reference Standard
There are 9 future patent(s) for this application. The earliest expires on 2025-11-26, and the latest expires on 2031-04-16.
| Patent No | Patent Expiration Date | Patent Title |
| 7896264 | 2025-05-26 | Microstructured high pressure nozzle with built-in filter function |
Exclusivities Expiring This Week
ARTESUNATE - POWDER;INTRAVENOUS - ARTESUNATE
From AMIVAS INC; an artemesinin derivative indicated for the initial treatment of severe malaria.
110MG/VIAL
Approved in May 26, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-05-26, and the latest expires on 2027-05-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-26 | NEW CHEMICAL ENTITY |
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 4 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-07, and the latest expires on 2029-05-27.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-27 | NEW PATIENT POPULATION |
