Dapaguliflozin is formulated into FARXIG (an oral tablet), QTERN (a combo tablet with saxagliptin HCl) and XIGDUO XR (an extended-release combo tablet with metformin HCl). Two products are discontinued:
Why did Zydus Pharma discontinue its product. Let us review the orange book patents for FARXIGA:
ORANGE BOOK PATENTS OF DAPAGLIFLOZIN (FARXIGA) 5 mg TABLET:
ORANGE BOOK PATENTS OF DAPAGLIFLOZIN (FARXIGA) 10 mg TABLET:
Zydus' Dapagliflozin tablets were approved on Feb 22, 2022 (ANDA 211582), while there were two new orange book patents for the FARXIGA 10 mg tablet, they were submitted on 4/21/2021 and 12/19/2023.
10973836 has four independent claims, and they are:1. A method of reducing the rate of cardiovascular death and worsening
heart failure in a patient with heart failure with reduced ejection
fraction (HFrEF), comprising administering to the patient a
pharmaceutical composition comprising a therapeutically effective amount
of dapagliflozin;
wherein the patient does not have type II diabetes;
wherein the patient is also administered at least one standard of care HF agent; and
wherein the rate for
cardiovascular death and worsening heart failure is reduced relative to
an administration regimen where the patient receives at least one
standard of care HF agent alone.
17. A method of reducing the rate of hospitalization for heart failure
and cardiovascular death in a patient following an acute myocardial
infarction, comprising administering to the patient a pharmaceutical
composition comprising a therapeutically effective amount of
dapagliflozin;
wherein the patient does not have type II diabetes;
wherein the patient is also administered at least one standard of care HF agent; and
wherein the rate for
hospitalization for heart failure and cardiovascular death is reduced
relative to an administration regimen where the patient receives at
least one standard of care HF agent alone.
22. A method of reducing the rate of cardiovascular death or worsening
heart failure symptoms in patients with acute decompensated heart
failure, comprising administering to the patient a pharmaceutical
composition comprising a therapeutically effective amount of
dapagliflozin;
wherein the patient does not have type II diabetes;
wherein the patient is also administered at least one standard of care HF agent; and
wherein the rate for
cardiovascular death and worsening heart failure is reduced relative to
an administration regimen where the patient receives at least one
standard of care HF agent alone.
28. A method of reducing the risk of hyperkalemia in patients with heart
failure, comprising administering to the patient a pharmaceutical
composition comprising a therapeutically effective amount of an SGLT2
inhibitor.
11826376 has only one independent claim:
1. A method for
(i) treating heart failure with preserved ejection fraction (HFpEF)
and/or (ii) treating and/or preventing at least one disease, disorder,
or condition associated with HFpEF, the method comprising administering
to a non-diabetic patient in need thereof a pharmaceutical composition
comprising a therapeutically effective amount of at least one compound
chosen from compounds of Formula (I)
and prodrugs thereof,
wherein the at least one
disease, disorder, or condition associated with HFpEF is chosen from
skeletal muscle dysfunction, vascular dysfunction, hypertension,
pulmonary hypertension, renal failure, anemia, atrial fibrillation, and
major adverse cardiovascular events, and wherein the non-diabetic patient is human, has a body mass index of <50 kg/m2, has HFpEF, and has hemoglobin A1c of <5.7%.
Here is the FARXIGA's indications, based on its product insert:
FARXIGA (dapagliflozin) is indicated:
- •
- To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
- •
- To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
- •
- To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
- •
- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
