Patent and Exclusivity Expirations Report
Report generated for the week of 2025-02-24 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 12 drugs in the patent and exclusivity list. They are:
Rukobia by VIIV Healthcare, containing active ingredient Fostemsavir tromethamine
Stiolto Respimat by Boehringer Ingelheim, containing active ingredients Olodaterol hydrochloride and Tiotropium bromide
Spiriva Respimat by Boehringer Ingelheim, containing active ingredient Tiotropium bromide
Veltassa by Vifor Pharma, containing active ingredient Patiromer sorbitex calcium
Xarelto by Janssen Pharmaceuticals, containing active ingredient Rivaroxaban
Airduo Respiclick by Teva Pharmaceuticals, containing active ingredients Fluticasone propionate and Salmeterol xinafoate
Xalkori by PF Prism CV, containing active ingredient Crizotinib
Jardiance by Boehringer Ingelheim, containing active ingredient Empagliflozin
Avycaz by AbbVie, containing active ingredients Avibactam sodium and Ceftazidime
Barhemsys by Acacia Pharma, containing active ingredient Amisulpride
Nurtec ODT by Pfizer, containing active ingredient Rimegepant sulfate
Mayzent by Novartis, containing active ingredient Siponimod
Patents Expiring This Week
CRIZOTINIB - CAPSULE, PELLETS;ORAL - XALKORI
From PF PRISM CV; a receptor tyrosine kinase inhibitor used to treat metastatic non-small cell lung cancer (NSCLC) where the tumors have been confirmed to be anaplastic lymphoma kinase (ALK), or ROS1-positive.
150MG
Approved in Sep 7, 2023, used as Reference Listed Drug and Reference Standard
20MG; 50MG
Approved in Sep 7, 2023, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2025-08-26, and the latest expires on 2029-11-06.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 8785632 | 2025-03-01 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
CRIZOTINIB - CAPSULE;ORAL - XALKORI
From PF PRISM CV; a receptor tyrosine kinase inhibitor used to treat metastatic non-small cell lung cancer (NSCLC) where the tumors have been confirmed to be anaplastic lymphoma kinase (ALK), or ROS1-positive.
200MG
Approved in Aug 26, 2011, used as Reference Listed Drug
250MG
Approved in Aug 26, 2011, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2025-08-26, and the latest expires on 2029-11-06.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 8785632 | 2025-03-01 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - POWDER;INHALATION - AIRDUO RESPICLICK
From TEVA PHARMACEUTICAL INDUSTRIES LTD; to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.
0.055MG/INH;EQ 0.014MG BASE/INH; 0.113MG/INH;EQ 0.014MG BASE/INH
Approved in Jan 27, 2017, used as Reference Listed Drug
0.232MG/INH;EQ 0.014MG BASE/INH
Approved in Jan 27, 2017, used as Reference Listed Drug and Reference Standard
There are 28 future patent(s) for this application. The earliest expires on 2025-05-19, and the latest expires on 2040-02-20.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 9987229*PED | 2025-03-01 | Process for preparing a medicament |
| 9616024*PED | 2025-03-01 | Process for preparing a medicament |
FOSTEMSAVIR TROMETHAMINE - TABLET, EXTENDED RELEASE;ORAL - RUKOBIA
From VIIV HEALTHCARE CO; an antiretroviral HIV-1 attachment inhibitor targeted against the gp120 subunit within the HIV-1 gp160 envelope glycoprotein.
EQ 600MG BASE
Approved in Jul 2, 2020, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2027-11-19, and the latest expires on 2029-07-13.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 8461333 | 2025-02-25 | Salts of prodrugs of piperazine and substituted piperidine antiviral agents |
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - SPRAY, METERED;INHALATION - STIOLTO RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), 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 10 future patent(s) for this application. The earliest expires on 2025-05-12, and the latest expires on 2030-10-16.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7284474*PED | 2025-02-26 |
|
PATIROMER SORBITEX CALCIUM - POWDER;ORAL - VELTASSA
From VIFOR PHARMA INC; a non-absorbable potassium binding polymer indicated for the treatment of hyperkalemia.
EQ 16.8GM BASE/PACKET
Approved in Oct 21, 2015, used as Reference Listed Drug and Reference Standard
EQ 8.4GM BASE/PACKET
Approved in Oct 21, 2015, used as Reference Listed Drug
EQ 1GM BASE/PACKET
Approved in Oct 2, 2023, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2027-03-14, and the latest expires on 2033-10-08.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
|---|
| 7556799 | U-1766 | TREATMENT OF HYPERKALEMIA | 2025-02-27 | Ion binding polymers and uses thereof |
RIVAROXABAN - FOR SUSPENSION;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC; a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE)
1MG/ML
Approved in Dec 20, 2021, used as Reference Listed Drug and Reference Standard
There are no future patents for this application.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7157456*PED | 2025-02-28 |
|
RIVAROXABAN - TABLET;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC; a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE)
15MG; 10MG
Approved in Nov 4, 2011, used as Reference Listed Drug
2.5MG
Approved in Oct 11, 2018, used as Reference Listed Drug
20MG
Approved in Nov 4, 2011, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2025-05-13, and the latest expires on 2039-07-31.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7157456*PED | 2025-02-28 |
|
TIOTROPIUM BROMIDE - SPRAY, METERED;INHALATION - SPIRIVA RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; for the maintenance of bronchospasm in COPD and to prevent exacerbations 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 10 future patent(s) for this application. The earliest expires on 2025-05-26, and the latest expires on 2031-04-16.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7284474*PED | 2025-02-26 |
|
Exclusivities Expiring This Week
AMISULPRIDE - SOLUTION;INTRAVENOUS - BARHEMSYS
From ACACIA PHARMA LTD; a dopamine D2 receptor antagonist used in the treatment of acute and chronic schizophrenia, and in the prevention and treatment of postoperative nausea and vomiting in adults.
10MG/4ML (2.5MG/ML); 5MG/2ML (2.5MG/ML)
Approved in Sep 1, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-26 | NEW CHEMICAL ENTITY |
AVIBACTAM SODIUM; CEFTAZIDIME - POWDER;INTRAVENOUS - AVYCAZ
From ABBVIE INC; to treat complicated stomach infections in adults, children, and premature babies born at least 31 weeks or later.
EQ 0.5GM BASE;2GM/VIAL
Approved in Feb 25, 2015, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-12-20, and the latest expires on 2027-01-26.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-25 | GENERATING ANTIBIOTIC INCENTIVES NOW |
EMPAGLIFLOZIN - TABLET;ORAL - JARDIANCE
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; as an adjunct to diet and exercise to improve glycemic control in patients aged 10 years and older with type 2 diabetes.
10MG
Approved in Aug 1, 2014, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-24, and the latest expires on 2026-12-20.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-24 | LABELING REVISIONS RELATED TO CLINICAL STUDIES |
RIMEGEPANT SULFATE - TABLET, ORALLY DISINTEGRATING;ORAL - NURTEC ODT
From PFIZER INC; an oral CGRP receptor antagonist used for the acute treatment of migraines with or without aura in adults.
EQ 75MG BASE
Approved in Feb 27, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-27 | NEW CHEMICAL ENTITY |
SIPONIMOD - TABLET;ORAL - MAYZENT
From NOVARTIS PHARMACEUTICALS CORP; for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults
EQ 0.25MG BASE
Approved in Mar 26, 2019, used as Reference Listed Drug
EQ 1MG BASE
Approved in Aug 24, 2021, used as Reference Listed Drug
EQ 2MG BASE
Approved in Mar 26, 2019, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-03-01 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130 |
Patent and Exclusivity Expirations Report
Report generated for the week of 2025-02-24 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 12 drugs in the patent and exclusivity list. They are:
Rukobia by VIIV Healthcare, containing active ingredient Fostemsavir tromethamine
Stiolto Respimat by Boehringer Ingelheim, containing active ingredients Olodaterol hydrochloride and Tiotropium bromide
Spiriva Respimat by Boehringer Ingelheim, containing active ingredient Tiotropium bromide
Veltassa by Vifor Pharma, containing active ingredient Patiromer sorbitex calcium
Xarelto by Janssen Pharmaceuticals, containing active ingredient Rivaroxaban
Airduo Respiclick by Teva Pharmaceuticals, containing active ingredients Fluticasone propionate and Salmeterol xinafoate
Xalkori by PF Prism CV, containing active ingredient Crizotinib
Jardiance by Boehringer Ingelheim, containing active ingredient Empagliflozin
Avycaz by AbbVie, containing active ingredients Avibactam sodium and Ceftazidime
Barhemsys by Acacia Pharma, containing active ingredient Amisulpride
Nurtec ODT by Pfizer, containing active ingredient Rimegepant sulfate
Mayzent by Novartis, containing active ingredient Siponimod
Patents Expiring This Week
CRIZOTINIB - CAPSULE, PELLETS;ORAL - XALKORI
From PF PRISM CV
150MG
Approved in Sep 7, 2023, used as Reference Listed Drug and Reference Standard
20MG; 50MG
Approved in Sep 7, 2023, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2025-08-26, and the latest expires on 2029-11-06.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 8785632 | 2025-03-01 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
CRIZOTINIB - CAPSULE;ORAL - XALKORI
From PF PRISM CV
200MG
Approved in Aug 26, 2011, used as Reference Listed Drug
250MG
Approved in Aug 26, 2011, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2025-08-26, and the latest expires on 2029-11-06.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 8785632 | 2025-03-01 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - POWDER;INHALATION - AIRDUO RESPICLICK
From TEVA PHARMACEUTICAL INDUSTRIES LTD
0.055MG/INH;EQ 0.014MG BASE/INH; 0.113MG/INH;EQ 0.014MG BASE/INH
Approved in Jan 27, 2017, used as Reference Listed Drug
0.232MG/INH;EQ 0.014MG BASE/INH
Approved in Jan 27, 2017, used as Reference Listed Drug and Reference Standard
There are 28 future patent(s) for this application. The earliest expires on 2025-05-19, and the latest expires on 2040-02-20.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 9987229*PED | 2025-03-01 | Process for preparing a medicament |
| 9616024*PED | 2025-03-01 | Process for preparing a medicament |
FOSTEMSAVIR TROMETHAMINE - TABLET, EXTENDED RELEASE;ORAL - RUKOBIA
From VIIV HEALTHCARE CO
EQ 600MG BASE
Approved in Jul 2, 2020, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2027-11-19, and the latest expires on 2029-07-13.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 8461333 | 2025-02-25 | Salts of prodrugs of piperazine and substituted piperidine antiviral agents |
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - SPRAY, METERED;INHALATION - STIOLTO RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC
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 10 future patent(s) for this application. The earliest expires on 2025-05-12, and the latest expires on 2030-10-16.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7284474*PED | 2025-02-26 |
|
PATIROMER SORBITEX CALCIUM - POWDER;ORAL - VELTASSA
From VIFOR PHARMA INC
EQ 16.8GM BASE/PACKET
Approved in Oct 21, 2015, used as Reference Listed Drug and Reference Standard
EQ 8.4GM BASE/PACKET
Approved in Oct 21, 2015, used as Reference Listed Drug
EQ 1GM BASE/PACKET
Approved in Oct 2, 2023, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2027-03-14, and the latest expires on 2033-10-08.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
|---|
| 7556799 | U-1766 | TREATMENT OF HYPERKALEMIA | 2025-02-27 | Ion binding polymers and uses thereof |
RIVAROXABAN - FOR SUSPENSION;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC
1MG/ML
Approved in Dec 20, 2021, used as Reference Listed Drug and Reference Standard
There are no future patents for this application.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7157456*PED | 2025-02-28 |
|
RIVAROXABAN - TABLET;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC
15MG; 10MG
Approved in Nov 4, 2011, used as Reference Listed Drug
2.5MG
Approved in Oct 11, 2018, used as Reference Listed Drug
20MG
Approved in Nov 4, 2011, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2025-05-13, and the latest expires on 2039-07-31.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7157456*PED | 2025-02-28 |
|
TIOTROPIUM BROMIDE - SPRAY, METERED;INHALATION - SPIRIVA RESPIMAT
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC
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 10 future patent(s) for this application. The earliest expires on 2025-05-26, and the latest expires on 2031-04-16.
| Patent No | Patent Expiration Date | Patent Title |
|---|
| 7284474*PED | 2025-02-26 |
|
Exclusivities Expiring This Week
AMISULPRIDE - SOLUTION;INTRAVENOUS - BARHEMSYS
From ACACIA PHARMA LTD
10MG/4ML (2.5MG/ML); 5MG/2ML (2.5MG/ML)
Approved in Sep 1, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-26 | NEW CHEMICAL ENTITY |
AVIBACTAM SODIUM; CEFTAZIDIME - POWDER;INTRAVENOUS - AVYCAZ
From ABBVIE INC
EQ 0.5GM BASE;2GM/VIAL
Approved in Feb 25, 2015, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-12-20, and the latest expires on 2027-01-26.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-25 | GENERATING ANTIBIOTIC INCENTIVES NOW |
EMPAGLIFLOZIN - TABLET;ORAL - JARDIANCE
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC
10MG
Approved in Aug 1, 2014, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-24, and the latest expires on 2026-12-20.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-24 | LABELING REVISIONS RELATED TO CLINICAL STUDIES |
RIMEGEPANT SULFATE - TABLET, ORALLY DISINTEGRATING;ORAL - NURTEC ODT
From PFIZER INC
EQ 75MG BASE
Approved in Feb 27, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-02-27 | NEW CHEMICAL ENTITY |
SIPONIMOD - TABLET;ORAL - MAYZENT
From NOVARTIS PHARMACEUTICALS CORP
EQ 0.25MG BASE
Approved in Mar 26, 2019, used as Reference Listed Drug
EQ 1MG BASE
Approved in Aug 24, 2021, used as Reference Listed Drug
EQ 2MG BASE
Approved in Mar 26, 2019, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|
| 2025-03-01 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130 |
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