Details:
Sevelamer hydrochloride tablets of strengths 400 mg and 800 mg used to control serum phosphorus in patients with chronic kidney disese (CKD) on dialysis.
Lead Product(s): Sevelamer Hydrochloride
Therapeutic Area: Nephrology Product Name: Renagel-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2023
Details:
Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose.
Lead Product(s): Empagliflozin
Therapeutic Area: Nephrology Product Name: Empagliflozin-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Details:
Bumetanide injection generic version of Bumex, is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions.
Lead Product(s): Bumetanide
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2023
Details:
Lupin has launched Sevelamer Hydrochloride tablets (800 mg), a generic equivalent of Genzyme, Renagel tablets, used to treat hyperphosphatemia in patients with chronic kidney disease, in the US market.
Lead Product(s): Sevelamer Hydrochloride
Therapeutic Area: Nephrology Product Name: Sevelamer Hydrochloride-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
Lupin received approval from the USFDA for its Abbreviated New Drug Application Sevelamer Carbonate for Oral Suspension, which is a generic equivalent of Renvela® for Oral Suspension, 0.8 g and 2.4 g Packets of Genzyme, used to treat increased phosphate levels in the blood.
Lead Product(s): Sevelamer Carbonate
Therapeutic Area: Nephrology Product Name: Sevelamer Carbonate-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 25, 2021
Details:
Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer Hydrochloride Tablets (RLD: Renagel®) had estimated annual sales of USD 80 million in the U.S.
Lead Product(s): Sevelamer Hydrochloride
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2021
Details:
Sevelamer Carbonate Tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.
Lead Product(s): Sevelamer Carbonate
Therapeutic Area: Nephrology Product Name: Sevelamer Carbonate-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
Details:
The approved ANDA is therapeutically equivalent to the reference listed drug product, Zaroxolyn Tablets 2.5 mg, 5 mg, and 1 O mg, of Lannett Company. Metolazone Tablets are indicated for the treatment of salt and water retention caused by heart failure or kidney disease.
Lead Product(s): Metolazone
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
The company launched generic version of sucroferric oxyhydroxide tablets, indicated for the control of increased serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Lead Product(s): Iron Sucrose
Therapeutic Area: Nephrology Product Name: Dynulta
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020