Patent and Exclusivity Expirations Report

Report generated for the week of 2024-11-11 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:
- JANSSEN PHARMACEUTICALS INC's XARELTO, containing active ingredient RIVAROXABAN
- KYOWA KIRIN INC's NOURIANZ, containing active ingredient ISTRADEFYLLINE
- SEAGEN INC's TUKYSA, containing active ingredient TUCATINIB
- VANDA PHARMACEUTICALS INC's PONVORY, containing active ingredient PONESIMOD
- AVEO PHARMACEUTICALS INC's FOTIVDA, containing active ingredient TIVOZANIB HYDROCHLORIDE
- BIOMARIN PHARMACEUTICAL INC's KUVAN, containing active ingredient SAPROPTERIN DIHYDROCHLORIDE
- PROVENSIS LTD's VARITHENA, containing active ingredient POLIDOCANOL
- BEIGENE USA INC's BRUKINSA, containing active ingredient ZANUBRUTINIB
- SHIONOGI INC's FETROJA, containing active ingredient CEFIDEROCOL SULFATE TOSYLATE

Patents Expiring This Week

ISTRADEFYLLINE - TABLET;ORAL - NOURIANZ

From KYOWA KIRIN INC; for the treatment of Parkinson's Disease.

20MG

Approved in Aug 27, 2019, used as Reference Listed Drug

There are 2 future patent(s) for this application. The earliest expires on 2027-09-05, and the latest expires on 2028-01-28.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7541363	NaN	NaN	2024-11-13

40MG

Approved in Aug 27, 2019, used as Reference Listed Drug and Reference Standard

There are 2 future patent(s) for this application. The earliest expires on 2027-09-05, and the latest expires on 2028-01-28.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7541363	NaN	NaN	2024-11-13

POLIDOCANOL - SOLUTION;INTRAVENOUS - VARITHENA

From PROVENSIS LTD; for the treatment of uncomplicated spider veins and uncomplicated reticular veins.

180MG/18ML (10MG/ML)

Approved in Nov 25, 2013, 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 2032-05-12.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7731986	U-1463	A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, ADMINISTERED VIA A SINGLE CANNULA INTO THE LUMEN OF THE TARGET INCOMPETENT TRUNK VEINS OR BY DIRECT INJECTION INTO VARICOSITIES	2024-11-17

PONESIMOD - TABLET;ORAL - PONVORY

From VANDA PHARMACEUTICALS INC; for the treatment of relapsing multiple sclerosis.

10MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16
RE43728	NaN	NaN	2024-11-16

20MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
RE43728	NaN	NaN	2024-11-16
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16

2MG

Approved in Mar 18, 2021, used as Reference Listed Drug and Reference Standard

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16
RE43728	NaN	NaN	2024-11-16

3MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
RE43728	NaN	NaN	2024-11-16
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16

4MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
RE43728	NaN	NaN	2024-11-16
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16

5MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16
RE43728	NaN	NaN	2024-11-16

6MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16
RE43728	NaN	NaN	2024-11-16

7MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16
RE43728	NaN	NaN	2024-11-16

8MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
RE43728	NaN	NaN	2024-11-16
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16

9MG

Approved in Mar 18, 2021, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2025-12-17, and the latest expires on 2042-10-10.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
RE43728	NaN	NaN	2024-11-16
9000018	U-3102	REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS	2024-11-16

RIVAROXABAN - TABLET;ORAL - XARELTO

From JANSSEN PHARMACEUTICALS INC; for the treatment of deep vein thrombosis and pulmonary embolism.

10MG

Approved in Jul 1, 2011, used as Reference Listed Drug

There are 6 future patent(s) for this application. The earliest expires on 2025-02-28, and the latest expires on 2039-07-31.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9415053	U-2640	PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING	2024-11-13
9415053	U-1167	PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)	2024-11-13
9415053	U-2142	REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR RECURRENT DVT AND/OR AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS	2024-11-13
9415053	U-3284	PROPHYLAXIS OF THROMBOEMBOLIC DISEASES IN PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE WHO HAVE UNDERGONE THE FONTAN PROCEDURE AND A BODY WEIGHT OF >=50 KG	2024-11-13

15MG

Approved in Nov 4, 2011, used as Reference Listed Drug

There are 6 future patent(s) for this application. The earliest expires on 2025-02-28, and the latest expires on 2039-07-31.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9415053	U-1301	TREATMENT OF DEEP VEIN THROMBOSIS (DVT)	2024-11-13
9415053	U-3286	TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF 30 KG TO 49.9 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT	2024-11-13
9415053	U-1302	TREATMENT OF PULMONARY EMBOLISM (PE)	2024-11-13
9415053	U-1200	REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM	2024-11-13

2.5MG

Approved in Oct 11, 2018, used as Reference Listed Drug

There are 6 future patent(s) for this application. The earliest expires on 2025-02-28, and the latest expires on 2039-07-31.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9415053	U-2435	REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CV DEATH, MI, AND STROKE) IN CHRONIC CAD OR PAD	2024-11-13
9415053	U-3206	REDUCTION OF RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD	2024-11-13
9415053	U-3205	REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION AND STROKE) IN PATIENTS WITH CAD	2024-11-13

20MG

Approved in Nov 4, 2011, used as Reference Listed Drug and Reference Standard

There are 6 future patent(s) for this application. The earliest expires on 2025-02-28, and the latest expires on 2039-07-31.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
9415053	U-3287	TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF >=50 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT	2024-11-13
9415053	U-1302	TREATMENT OF PULMONARY EMBOLISM (PE)	2024-11-13
9415053	U-1301	TREATMENT OF DEEP VEIN THROMBOSIS (DVT)	2024-11-13
9415053	U-1200	REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM	2024-11-13

SAPROPTERIN DIHYDROCHLORIDE - POWDER;ORAL - KUVAN

From BIOMARIN PHARMACEUTICAL INC; for the treatment of phenylketonuria.

100MG/PACKET

Approved in Dec 19, 2013, used as Reference Listed Drug and Reference Standard

There are 7 future patent(s) for this application. The earliest expires on 2025-05-17, and the latest expires on 2033-05-01.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7612073	U-1010	TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION	2024-11-17
9433624	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
8067416	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
7566714	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
RE43797	U-1590	KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA	2024-11-17

500MG/PACKET

Approved in Oct 27, 2015, used as Reference Listed Drug

There are 7 future patent(s) for this application. The earliest expires on 2025-05-17, and the latest expires on 2033-05-01.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7566714	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
8067416	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
RE43797	U-1590	KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA	2024-11-17
9433624	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
7612073	U-1010	TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION	2024-11-17

SAPROPTERIN DIHYDROCHLORIDE - TABLET;ORAL - KUVAN

From BIOMARIN PHARMACEUTICAL INC; for the treatment of phenylketonuria.

100MG

Approved in Dec 13, 2007, used as Reference Listed Drug and Reference Standard

There are 11 future patent(s) for this application. The earliest expires on 2025-05-17, and the latest expires on 2026-05-16.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
RE43797	U-1156	TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA (HPA)	2024-11-17
9433624	U-1589	METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
8067416	U-989	FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
7566714	U-989	FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA	2024-11-17
7727987	NaN	NaN	2024-11-17
7612073	U-1010	TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION	2024-11-17
8318745	NaN	NaN	2024-11-17

TIVOZANIB HYDROCHLORIDE - CAPSULE;ORAL - FOTIVDA

From AVEO PHARMACEUTICALS INC; for the treatment of renal cell carcinoma.

EQ 0.89MG BASE

Approved in Mar 10, 2021, used as Reference Listed Drug

There are 2 future patent(s) for this application. The earliest expires on 2025-04-26, and the latest expires on 2039-11-05.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7166722	NaN	NaN	2024-11-16

EQ 1.34MG BASE

Approved in Mar 10, 2021, used as Reference Listed Drug and Reference Standard

There are 2 future patent(s) for this application. The earliest expires on 2025-04-26, and the latest expires on 2039-11-05.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7166722	NaN	NaN	2024-11-16

TUCATINIB - TABLET;ORAL - TUKYSA

From SEAGEN INC; for the treatment of certain types of unresectable/metastatic HER2 positive breast cancer.

150MG

Approved in Apr 17, 2020, used as Reference Listed Drug and Reference Standard

There are 7 future patent(s) for this application. The earliest expires on 2027-05-09, and the latest expires on 2038-04-27.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7452895	U-2788	TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER	2024-11-16

50MG

Approved in Apr 17, 2020, used as Reference Listed Drug

There are 7 future patent(s) for this application. The earliest expires on 2027-05-09, and the latest expires on 2038-04-27.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date
7452895	U-2788	TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER	2024-11-16

Exclusivities Expiring This Week

CEFIDEROCOL SULFATE TOSYLATE - POWDER;INTRAVENOUS - FETROJA

From SHIONOGI INC; for the treatment of complicated urinary tract infections.

EQ 1GM BASE/VIAL

Approved in Nov 14, 2019, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-11-14, and the latest expires on 2029-11-14.

Exclusivity Date	Exclusivity Use Definition
2024-11-14	NEW CHEMICAL ENTITY

ZANUBRUTINIB - CAPSULE;ORAL - BRUKINSA

From BEIGENE USA INC; for the treatment of mantle cell lymphoma.

80MG

Approved in Nov 14, 2019, used as Reference Listed Drug and Reference Standard

There are 7 future exclusivity(ies) for this drug product. The earliest expires on 2026-01-19, and the latest expires on 2031-03-07.

Exclusivity Date	Exclusivity Use Definition
2024-11-14	NEW CHEMICAL ENTITY