Patent and Exclusivity Expirations Report
Report generated for the week of 2025-05-12 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:
Zydelig by Gilead Sciences Inc, containing active ingredient Idelalisib
Striverdi Respimat by Boehringer Ingelheim Pharmaceuticals Inc, containing active ingredient Olodaterol Hydrochloride
Lymphoseek Kit by Cardinal Health 414 LLC, containing active ingredient Technetium Tc-99m Tilmanocept
Stiolto Respimat by Boehringer Ingelheim Pharmaceuticals Inc, containing active ingredients Olodaterol Hydrochloride and Tiotropium Bromide
Xarelto by Janssen Pharmaceuticals Inc, containing active ingredient Rivaroxaban
Defencath by Cormedix Inc, containing active ingredients Heparin Sodium and Taurolidine
Kuvan by Biomarin Pharmaceutical Inc, containing active ingredient Sapropterin Dihydrochloride
Radicava ORS by Mitsubishi Tanabe Pharma Corp, containing active ingredient Edaravone
Qinlock by Deciphera Pharmaceuticals LLC, containing active ingredient Ripretinib
Patents Expiring This Week
HEPARIN SODIUM; TAUROLIDINE - SOLUTION;N/A - DEFENCATH
From CORMEDIX INC; used to reduce the incidence of catherter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.
3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)
5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)
Approved in Nov 15, 2023, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2042-04-15, and the latest expires on 2042-04-15.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7696182 | U-3774 | A CATHETER LOCK SOLUTION TO REDUCE CATHETER-RELATED BLOODSTREAM INFECTIONS IN ADULT PATIENTS RECEIVING HEMODIALYSIS THROUGH A CENTRAL VENOUS CATHETER | 2025-05-16 | Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin |
IDELALISIB - TABLET;ORAL - ZYDELIG
From GILEAD SCIENCES INC; used to treat chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma.
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 6 future patent(s) for this application. The earliest expires on 2025-07-21, and the latest expires on 2033-09-02.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8980901 | U-1678 | FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL | 2025-05-12 | 5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta |
| 9149477 | U-1757 | INHIBITION ON PI3K KINASE | 2025-05-12 | 5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta |
OLODATEROL HYDROCHLORIDE - SPRAY, METERED;INHALATION - STRIVERDI RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; a long-acting beta2-adrenergic agonist used in the management of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
EQ 0.0025MG BASE/INH
Approved in Jul 31, 2014, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2025-05-26, and the latest expires on 2030-10-16.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7220742 | U-1547 | TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR EMPHYSEMA | 2025-05-12 | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
| 8034809 | U-1547 | TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR EMPHYSEMA | 2025-05-12 | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
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 8 future patent(s) for this application. The earliest expires on 2025-05-26, and the latest expires on 2030-10-16.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8034809 | U-1702 | TREATMENT OF COPD | 2025-05-12 | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
| 7220742 | U-1703 | TREATMENT OF RESPIRATORY COMPLAINTS | 2025-05-12 | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
RIVAROXABAN - TABLET;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC; a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE)
20MG
Approved in Nov 4, 2011, used as Reference Listed Drug and Reference Standard
2.5MG; 10MG; 15MG
Approved in Jul 1, 2011, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2034-02-17, and the latest expires on 2039-07-31.
| Patent No | Patent Expiration Date | Patent Title |
| 9415053*PED | 2025-05-13 | Solid, orally administrable pharmaceutical composition |
SAPROPTERIN DIHYDROCHLORIDE - POWDER;ORAL - KUVAN
From BIOMARIN PHARMACEUTICAL INC; a cofactor used as an adjunct to phenylalanine restriction in the treatment of phenylketonuria (PKU).
100MG/PACKET
Approved in Dec 19, 2013, used as Reference Listed Drug and Reference Standard
500MG/PACKET
Approved in Oct 27, 2015, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2032-11-01, and the latest expires on 2033-05-01.
| Patent No | Patent Expiration Date | Patent Title |
| 7566714*PED | 2025-05-17 | Methods and compositions for the treatment of metabolic disorders |
| 9433624*PED | 2025-05-17 | Methods and compositions for the treatment of metabolic disorders |
| RE43797*PED | 2025-05-17 | Methods of administering tetrahydrobiopterin |
| 8067416*PED | 2025-05-17 | Methods and compositions for the treatment of metabolic disorders |
| 7612073*PED | 2025-05-17 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
SAPROPTERIN DIHYDROCHLORIDE - TABLET;ORAL - KUVAN
From BIOMARIN PHARMACEUTICAL INC; a cofactor used as an adjunct to phenylalanine restriction in the treatment of phenylketonuria (PKU).
100MG
Approved in Dec 13, 2007, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2025-11-16, and the latest expires on 2026-05-16.
| Patent No | Patent Expiration Date | Patent Title |
| 7727987*PED | 2025-05-17 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
| 7612073*PED | 2025-05-17 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
| 8067416*PED | 2025-05-17 | Methods and compositions for the treatment of metabolic disorders |
| 7566714*PED | 2025-05-17 | Methods and compositions for the treatment of metabolic disorders |
| RE43797*PED | 2025-05-17 | Methods of administering tetrahydrobiopterin |
| 9433624*PED | 2025-05-17 | Methods and compositions for the treatment of metabolic disorders |
| 8318745*PED | 2025-05-17 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
TECHNETIUM TC-99M TILMANOCEPT - INJECTABLE;INJECTION - LYMPHOSEEK KIT
From CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES; a radioactive diagnostic agent
Exclusivities Expiring This Week
EDARAVONE - SUSPENSION;ORAL - RADICAVA ORS
From MITSUBISHI TANABE PHARMA CORP; a free radical scavenger used to delay the progression of ALS.
105MG/5ML
Approved in May 12, 2022, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-05-12, and the latest expires on 2029-05-12.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-12 | NEW PRODUCT |
RIPRETINIB - TABLET;ORAL - QINLOCK
From DECIPHERA PHARMACEUTICALS LLC; a kinase inhibitor used to treat advanced gastrointestinal stromal tumor (GIST).
50MG
Approved in May 15, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-05-15, and the latest expires on 2027-05-15.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-15 | NEW CHEMICAL ENTITY |
