Patent and Exclusivity Expirations Report

Report generated for the week of 2025-04-14 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 6 drugs in the patent and exclusivity list. They are:

• Kyprolis by Onyx Pharmaceuticals (Amgen), containing active ingredient Carfilzomib

• Symtuza by Janssen Products, containing active ingredient Cobicistat, Darunavir, Emtricitabine, and Tenofovir Alafenamide Fumarate

• Pemazyre by Incyte Corporation, containing active ingredient Pemigatinib

• Tukysa by Seagen, containing active ingredient Tucatinib

• Tavalisse by Rigel Pharmaceuticals, containing active ingredient Fostamatinib Disodium

• Tagrisso by AstraZeneca, containing active ingredient Osimertinib Mesylate

Patents Expiring This Week

CARFILZOMIB - POWDER;INTRAVENOUS - KYPROLIS

From ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC; a proteasome inhibitor for the treatment of multiple myeloma.

60MG/VIAL

Approved in Jul 20, 2012, used as Reference Listed Drug and Reference Standard

10MG/VIAL

Approved in Jun 7, 2018, used as Reference Listed Drug

30MG/VIAL

Approved in Jun 3, 2016, used as Reference Listed Drug

There are 4 future patent(s) for this application. The earliest expires on 2026-07-20, and the latest expires on 2033-02-27.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
8207125			2025-04-14	Compounds for enzyme inhibition
8207297			2025-04-14	Compounds for enzyme inhibition
8207126			2025-04-14	Compounds for enzyme inhibition
7232818			2025-04-14	Compounds for enzyme inhibition
7491704	U-2319	KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
8207127	U-2320	KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
8129346	U-2320	KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
8129346	U-2319	KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
8207127	U-2319	KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
8207127	U-2947	KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
7491704	U-2320	KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
8129346	U-2947	KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition
7491704	U-2947	KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY	2025-04-14	Compounds for enzyme inhibition

COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - SYMTUZA

From JANSSEN PRODUCTS LP; anti-HIV

150MG;800MG;200MG;EQ 10MG BASE

Approved in Jul 17, 2018, used as Reference Listed Drug and Reference Standard

There are 6 future patent(s) for this application. The earliest expires on 2026-12-26, and the latest expires on 2038-07-19.

Patent No	Patent Expiration Date	Patent Title
7390791	2025-04-17	Prodrugs of phosphonate nucleotide analogues

Exclusivities Expiring This Week

FOSTAMATINIB DISODIUM - TABLET;ORAL - TAVALISSE

From RIGEL PHARMACEUTICALS INC; a spleen tyrosine kinase inhibitor, for the treatment of chronic immune thrombocytopenia.

EQ 100MG BASE

Approved in Apr 17, 2018, used as Reference Listed Drug

EQ 150MG BASE

Approved in Apr 17, 2018, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-04-17	FOR THE TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

OSIMERTINIB MESYLATE - TABLET;ORAL - TAGRISSO

From ASTRAZENECA PHARMACEUTICALS LP; for the treatment of non-small cell lung cancer.

EQ 80MG BASE

Approved in Nov 13, 2015, used as Reference Listed Drug and Reference Standard

EQ 40MG BASE

Approved in Nov 13, 2015, used as Reference Listed Drug

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2027-02-16, and the latest expires on 2027-12-18.

Exclusivity Date	Exclusivity Use Definition
2025-04-18	INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST

PEMIGATINIB - TABLET;ORAL - PEMAZYRE

From INCYTE CORP; a kinase inhibitor for the treatment of locally advanced or metastatic, unresectable cholangiocarcinoma in previously treated adult patients.

13.5MG

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

4.5MG; 9MG

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

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-26, and the latest expires on 2029-08-26.

Exclusivity Date	Exclusivity Use Definition
2025-04-17	NEW CHEMICAL ENTITY

TUCATINIB - TABLET;ORAL - TUKYSA

From SEAGEN INC; for the treatment of certain types of unresectable/metastatic HER-2 positive breast cancer.

150MG

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

50MG

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

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-01-19, and the latest expires on 2030-01-19.

Exclusivity Date	Exclusivity Use Definition
2025-04-17	NEW CHEMICAL ENTITY