This week, there are 5 drugs in the patent and exclusivity list. They are:
Mirvaso by Galderma Laboratories LP, containing active ingredient Brimonidine Tartrate
Xalkori by PF Prism CV, containing active ingredient Crizotinib
Givlaari by Alnylam Pharmaceuticals Inc, containing active ingredient Givosiran Sodium
Pemazyre by Incyte Corp, containing active ingredient Pemigatinib
Winlevi by Sun Pharmaceutical Industries Ltd, containing active ingredient Clascoterone
Patents Expiring This Week
BRIMONIDINE TARTRATE - GEL;TOPICAL - MIRVASO
From GALDERMA LABORATORIES LP; to treat facial rosacea (enlarged facial blood vessels) in adults.
EQ 0.33% BASE
Approved in Aug 23, 2013, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2031-03-25, and the latest expires on 2031-06-13.
Patent No
Patent Use Code
Patent Use Definition
Patent Expiration Date
Patent Title
7439241
U-1428
TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
2025-08-25
Compounds, formulations, and methods for treating or preventing rosacea
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 3 future patent(s) for this application. The earliest expires on 2027-05-12, and the latest expires on 2029-11-06.
Patent No
Patent Expiration Date
Patent Title
7230098
2025-08-26
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.
250MG
Approved in Aug 26, 2011, used as Reference Listed Drug and Reference Standard
200MG
Approved in Aug 26, 2011, used as Reference Listed Drug
There are 3 future patent(s) for this application. The earliest expires on 2027-05-12, and the latest expires on 2029-11-06.
Patent No
Patent Expiration Date
Patent Title
7230098
2025-08-26
Aminoheteroaryl compounds as protein kinase inhibitors
From ALNYLAM PHARMACEUTICALS INC; a 5-aminolevulinic acid synthase-directed small interfering RNA (siRNA) used in the prophylaxis of acute hepatic porphyria.
EQ 189MG BASE/ML (EQ 189MG BASE/ML)
Approved in Nov 20, 2019, used as Reference Listed Drug and Reference Standard
There are 8 future patent(s) for this application. The earliest expires on 2028-08-24, and the latest expires on 2034-10-03.
Patent No
Patent Expiration Date
Patent Title
9150605
2025-08-28
Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
Exclusivities Expiring This Week
CLASCOTERONE - CREAM;TOPICAL - WINLEVI
From SUN PHARMACEUTICAL INDUSTRIES LTD; an androgen receptor antagonist used for the topical treatment of acne vulgaris in patients 12 years of age and older.
1%
Approved in Aug 26, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
Exclusivity Date
Exclusivity Use Definition
2025-08-26
NEW CHEMICAL ENTITY
PEMIGATINIB - TABLET;ORAL - PEMAZYRE
From INCYTE CORP; a kinase inhibitor used to treat 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 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-04-17, and the latest expires on 2029-08-26.
Exclusivity Date
Exclusivity Use Definition
2025-08-26
TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT
