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[{"orgOrder":0,"company":"Emcure Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Emcure Pharma Launches Generic Drug for Hyperphosphatemia in Chronic Kidney Disease Patients","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Emcure Pharmaceuticals"},{"orgOrder":0,"company":"Alembic Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Pharmaceuticals Announces USFDA Final Approval for Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Alembic Pharmaceuticals Limited"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives Approval for Sevelamer Carbonate Tablets","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lupin Ltd"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives US FDA Approval to Market Generic Renagel Tablets","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lupin Ltd"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives Approval from U.S. FDA for Sevelamer Carbonate for Oral Suspension","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lupin Ltd"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Launches Generic Medication in US Market","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Lupin Ltd"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals Launches Generic Version of Diuretic Bumetanide Injection","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Glenmark Pharmaceuticals"},{"orgOrder":0,"company":"Sun Pharmaceutical Industries Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sun's Generic Empagliflozin Receives Approval in U.S.","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Sun Pharmaceutical Industries Limited"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aurobindo Pharma Arm Gets USFDA Nod for Sevelamer Hydrochloride Tablets","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Aurobindo Pharma Limited"}]

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            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

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            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

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            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

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            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

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            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

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            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

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            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

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            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

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            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

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