This week, there are 6 drugs in the patent and exclusivity list. They are:
Ozempic by Novo Nordisk Inc, containing active ingredient Semaglutide
Victoza by Novo Nordisk Inc, containing active ingredient Liraglutide
Saxenda by Novo Nordisk Inc, containing active ingredient Liraglutide
Viltepso by Nippon Shinyaku Co Ltd, containing active ingredient Viltolarsen
Kalydeco by Vertex Pharmaceuticals Inc, containing active ingredient Ivacaftor
Lenvima by Eisai Inc, containing active ingredient Lenvatinib Mesylate
Patents Expiring This Week
LIRAGLUTIDE - SOLUTION;SUBCUTANEOUS - SAXENDA
From NOVO NORDISK INC; used for weight loss and to help keep weight off once weight has been lost, it is used for obese adults or overweight adults who also have weight-related medical problems.
18MG/3ML (6MG/ML)
Approved in Dec 23, 2014, used as Reference Listed Drug and Reference Standard
There are 3 future patent(s) for this application. The earliest expires on 2026-02-13, and the latest expires on 2037-07-09.
Patent No
Patent Expiration Date
Patent Title
8114833
2025-08-13
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
LIRAGLUTIDE - SOLUTION;SUBCUTANEOUS - VICTOZA
From NOVO NORDISK INC; used together with diet and exercise to improve blood sugar control in adults and children 10 years of age and older with type 2 diabetes.
18MG/3ML (6MG/ML)
Approved in Jan 25, 2010, used as Reference Listed Drug and Reference Standard
There are 3 future patent(s) for this application. The earliest expires on 2026-02-13, and the latest expires on 2037-07-09.
Patent No
Patent Expiration Date
Patent Title
8114833
2025-08-13
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
SEMAGLUTIDE - SOLUTION;SUBCUTANEOUS - OZEMPIC
From NOVO NORDISK INC; used for adults with type 2 diabetes to lower their blood sugar levels (A1C). It is also used to reduce the risk of kidney function decline in diabetics with chronic kidney disease (CKD) and lower the risk of heart attack or stroke in certain patients with type 2 diabetes and heart disease.
2MG/1.5ML (1.34MG/ML)
Approved in Dec 5, 2017, used as Reference Listed Drug and Reference Standard
4MG/3ML (1.34MG/ML)
Approved in Apr 9, 2019, used as Reference Listed Drug and Reference Standard
2MG/3ML (0.68MG/ML); 8MG/3ML (2.68MG/ML)
Approved in Mar 28, 2022, used as Reference Listed Drug and Reference Standard
There are 17 future patent(s) for this application. The earliest expires on 2025-10-20, and the latest expires on 2033-06-21.
Patent No
Patent Expiration Date
Patent Title
8114833
2025-08-13
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Exclusivities Expiring This Week
IVACAFTOR - GRANULE;ORAL - KALYDECO
From VERTEX PHARMACEUTICALS INC; used to treat cystic fibrosis in adults and children who are at least 1 month old and weigh at least 6 pounds (3 kilograms).
75MG/PACKET; 50MG/PACKET
Approved in Mar 17, 2015, used as Reference Listed Drug and Reference Standard
25MG/PACKET
Approved in Apr 29, 2019, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-04-29, and the latest expires on 2030-05-03.
Exclusivity Date
Exclusivity Use Definition
2025-08-15
THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
IVACAFTOR - TABLET;ORAL - KALYDECO
From VERTEX PHARMACEUTICALS INC; used to treat cystic fibrosis in adults and children who are at least 1 month old and weigh at least 6 pounds (3 kilograms).
150MG
Approved in Jan 31, 2012, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-12-21, and the latest expires on 2027-12-21.
Exclusivity Date
Exclusivity Use Definition
2025-08-15
THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
LENVATINIB MESYLATE - CAPSULE;ORAL - LENVIMA
From EISAI INC; a receptor tyrosine kinase inhibitor used for the treatment of metastatic thyroid cancer, advanced renal cell carcinoma in combination with everolimus, and unresectable hepatocellular carcinoma.
EQ 10MG BASE
Approved in Feb 13, 2015, used as Reference Listed Drug and Reference Standard.
EQ 4MG BASE
Approved in Feb 13, 2015, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-02-15, and the latest expires on 2027-10-03.
Exclusivity Date
Exclusivity Use Definition
2025-08-15
INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
VILTOLARSEN - SOLUTION;INTRAVENOUS - VILTEPSO
From NIPPON SHINYAKU CO LTD; an antisense phosphorodiamidate morpholino oligonucleotide specific for exon 53 of the human DMD gene that is capable of inducing exon 53 skipping to produce a functional truncated dystrophin protein in Duchenne muscular dystrophy patients with specific underlying mutations.
250MG/5ML (50MG/ML)
Approved in Aug 12, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-08-12, and the latest expires on 2027-08-12.
