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Enlicitide
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Enlicitide 2407527-14-2 2027 [Indication]
1. Hypercholesterolemia: As an adjunct to diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with hypercholesterolemia.
2. Heterozygous familial hypercholesterolemia (HeFH): For the treatment of adult patients with heterozygous familial hypercholesterolemia (HeFH).
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Etelcacetide
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Etelcacetide 1262780-97-1 Oct, 2026 Feb.7, 2031 estimated PV Completion – Apr, 2026 [Indication]
It is a calcimimetic agent indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
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Eltrombopag Olamine
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Eltrombopag Olamine 496775-62-3 37134 May.20, 2023 Commercial Production [Indication]
1. For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
2. For the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy.
3. For the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
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Elagolix Sodium
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Elagolix Sodium 834153-87-6 36738 Jul.06, 2024 PV Completion [Indication]
For the management of moderate to severe pain associated with endometriosis.
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Ezetimibe
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Ezetimibe 163222-33-1 24511, 35963 Commercial Production [Indication]
1. In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in adults with primary (heterozygous familial and non-familial) hyperlipidemia.
2. In combination with a statin, as an adjunct to diet to reduce elevated LDL-C, total-C, and Apo B in adults and pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).
3. As an adjunct to diet for the treatment of patients with homozygous familial sitosterolemia (phytosterolemia), to reduce elevated sitosterol and campesterol levels.
4. In combination with a statin, as an adjunct to diet, for the treatment of patients with established atherosclerotic cardiovascular disease (ASCVD) to reduce elevated LDL-C.
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Enalaprilat
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Enalaprilat 76420-72-9 Commercial Production [Indication]
1. For the treatment of hypertension when oral administration of enalapril is not practical.
2. For the treatment of congestive heart failure, particularly in patients who are unable to take oral medications.
