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Remibrutinib
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Remibrutinib 1787294-07-8 Jun, 2028 Nov.13, 2034 estimated PV Completion - Mar, 2028 [Indication]
Chronic spontaneous urticaria (CSU): For the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
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Resmetirom
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Resmetirom 920509-32-6 Dec, 2025 Spe.17, 2033 PV Completion [Indication]
Resmetirom is indicated as an adjunct therapy, alongside diet and exercise, for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (F2 to F3 fibrosis).
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Remdesivir
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Remdesivir 1809249-37-3 ✓ Commercial Production [Indication]
1. For the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients.
2. For the treatment of non-hospitalized adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death.
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Ruxolitinib Phosphate
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Ruxolitinib Phosphate 1092939-17-7 ✓ Jun.12, 2028 PV Completion [Indication]
1. Treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
2. Treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
3. Treatment of acute or chronic graft-versus-host disease (GVHD) in patients 12 years of age and older who have had an inadequate response to corticosteroids or other systemic therapies.
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Rimegepant Sulfate
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Rimegepant Sulfate 1374024-48-2 38655 Mar.9, 2030 PV Completion [Indication]
1. For the acute treatment of migraine with and without aura in adults.
2. For the preventive treatment of migraine in adults.
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Ribociclib Succinate
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Ribociclib Succinate 1374639-75-4 [Indication]
Indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
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Rivaroxaban
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Rivaroxaban 366789-02-8 34436 Commercial Production [Indication]
1. Prophylaxis of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery, or other orthopedic surgeries.
2. To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
3. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in risk of recurrent DVT and PE.
4. To reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with chronic coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD).
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Rosuvastatin Calcium
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Rosuvastatin Calcium 147098-20-2 20705, 34974 Commercial Production [Indication]
1. Adjunctive therapy to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia. Also indicated as an adjunct to diet and other LDL-lowering treatments in patients with homozygous familial hypercholesterolemia.
2. To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular disease based on age and other risk factors.
3. To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in patients with established atherosclerotic cardiovascular disease.
4. Adjunctive therapy to diet in pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia.
