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Tirzepatide
API’s Name CAS No. US DMF Patent Expiry Date (US) Current status Tirzepatide 2023788-19-2 2026 Jan.05, 2036 estimated PV Completion – 2026 [Indication]
1. As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
2. As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30 kg/m² (obesity) or ≥27 kg/m² (overweight) with at least one weight-related comorbidity.
3. For the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity.
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Thalidomide
API’s Name CAS No. US DMF Patent Expiry Date (US) Current status Thalidomide 50-35-1 Commercial Production [Indication]
1. In combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).
2. For the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and for maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence.
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Ticagrelor
API’s Name CAS No. US DMF Patent Expiry Date (US) Current status Ticagrelor 274693-27-5 28984, 34835 Oct.30, 2024 Commercial Production [Indication]
1. To reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
2. To reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS.
3. To reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM).
4. To reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).
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Tofacitnib Citrate
API’s Name CAS No. US DMF Patent Expiry Date (US) Current status Tofacitnib Citrate 540737-29-9 35746 Mar.25, 2023 Commercial Production [Indication]
1. For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
2. For the treatment of adult patients with active psoriatic arthritis (PsA), as monotherapy or in combination with MTX or other non-biologic DMARDs.
3. For the treatment of adult patients with active ankylosing spondylitis (AS).
4. For the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
5. For the treatment of pediatric patients 12 years of age and older with active polyarticular juvenile idiopathic arthritis (polyJIA).