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[{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Exeltis Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lupin Signs Distribution Agreement in Key EU Territories for Orphan Drug NaMuscla\u00ae","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2020","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 for Penicillamine Tablets USP","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2020","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 Penicillamine Tablets USP","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2021","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 Receives USFDA Approval for Icatibant Injection, 30 mg\/3 mL (10 mg\/mL) Single-Dose Prefilled Syringe","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Glenmark Pharmaceuticals"},{"orgOrder":0,"company":"Dr. Reddy's Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Reddy's Laboratories Announces the Launch of A Generic Version of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg in the U.S. Market","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Dr. Reddy\\'s Laboratories"},{"orgOrder":0,"company":"Dr. Reddy's Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Reddy's Laboratories Announces the Launch of A Generic Version of Sapropterin Dihydrochloride Tablets for Oral Use in the U.S. Market","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Dr. Reddy\\'s Laboratories"},{"orgOrder":0,"company":"Dr. Reddy's Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Reddy's Laboratories Announces the Launch of Penicillamine Capsules USP, 250 mg in the U.S. Market","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Dr. Reddy\\'s Laboratories"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aurobindo Receives FDA Approval for Colchicine Tablets USP, 0.6mg","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Aurobindo Pharma Limited"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aurobindo Pharma Gets U.S. FDA nod for Generic Icatibant Injection","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Peptide","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Peptide","graph2":"Aurobindo Pharma Limited"}]

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            Details:

            The launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, is approved by the U.S. Food and Drug Administration (USFDA).

            Lead Product(s): Sapropterin Hydrochloride

            Therapeutic Area: Genetic Disease Product Name: Sapropterin Dihydrochloride-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 April 07, 2021

            Details:

            The launch of generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating the commitment to bring affordable generic medicines to market for patients. Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottle count sizes of 120.

            Lead Product(s): Sapropterin Hydrochloride

            Therapeutic Area: Genetic Disease Product Name: Sapropterin Dihydrochloride-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 October 03, 2020

            Details:

            Penicillamine-Generic is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy.

            Lead Product(s): Penicillamine

            Therapeutic Area: Genetic Disease Product Name: Penicillamine-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 August 27, 2020

            Details:

            Icatibant injection, for subcutaneous is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema in adults 18 years of ageand older.

            Lead Product(s): Icatibant Acetate

            Therapeutic Area: Genetic Disease Product Name: Firazyr-Generic

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 16, 2023

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            Colchicine tablets inhibits the beta tubulin polymerisation, which is indicated for prophylaxis of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older

            Lead Product(s): Colchicine

            Therapeutic Area: Genetic Disease Product Name: Colcrys-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 12, 2022

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            Details:

            This marks Glenmark's first synthetic decapeptide Icatibant Injection approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.

            Lead Product(s): Icatibant Acetate

            Therapeutic Area: Genetic Disease 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 May 24, 2021

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            Details:

            Penicillamine tablets USP, 250 mg, are the generic equivalent of Depen tablets, 250 mg, of Mylan and indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to conventional therapy.

            Lead Product(s): Penicillamine

            Therapeutic Area: Genetic Disease Product Name: Depen

            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 03, 2021

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            Details:

            Lupin has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depen® Tablets, 250 mg, of Mylan Specialty, L.P.

            Lead Product(s): Penicillamine

            Therapeutic Area: Genetic Disease 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 01, 2020

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            Details:

            Under the agreements, Exeltis Healthcare will commercialize NaMuscla® in Spain and Portugal, Cresco Pharma B.V will commercialize NaMuscla® in the Netherlands and Macure Pharma ApS in the Nordic countries. Lupin will continue commercialization of NaMuscla® in Germany and UK.

            Lead Product(s): Mexiletine

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Exeltis Healthcare

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 03, 2020

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