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Atogepant
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Atogepant 1374248-81-3 Jun, 2027 Sep.28, 2035 estimated PV Completion – Apr, 2027 [Indication]
1. For the preventive treatment of episodic migraine in adults.
2. For the preventive treatment of chronic migraine in adults.
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Asciminib
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Asciminib 2119669-71-3 Jul, 2027 May.13, 2033 estimated PV Completion – May, 2027 [Indication]
1. Patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) who have been previously treated with two or more tyrosine kinase inhibitors (TKIs).
2. Patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) who have the T315I mutation.
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Alectinib Hydrochloride
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Alectinib Hydrochloride 1256589-74-8 Feb, 2027 Jun.9, 2030 estimated PV Completion – Dec, 2026 [Indication]
1. For the adjuvant treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) after surgery.
2. For the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC).
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Aprocitentan
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Aprocitentan 1103522-45-7 Dec, 2026 Sep.21, 2034 estimated PV Completion – Oct, 2026 [Indication]
For the treatment of hypertension, in combination with other antihypertensive agents.
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Abemaciclib
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Abemaciclib 1231929-97-7 ✓ Dec.15, 2029 PV Completion [Indication]
1. In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive, early breast cancer at high risk of recurrence.
2. In combination with an aromatase inhibitor for the initial endocrine-based therapy of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.
3. In combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
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Apremilast
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Apremilast 608141-41-9 37882 PV Completion [Indication]
1. Psoriatic Arthritis (PsA): For the treatment of adult patients with active psoriatic arthritis.
2. Plaque Psoriasis: For the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
3. Oral Ulcers Associated with Behçet’s Disease: For the treatment of oral ulcers associated with Behçet’s disease in adults.
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Abrocitinib
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Abrocitinib 1622902-68-4 39291 Feb.19, 2034 PV Completion [Indication]
For the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
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Agomelatine
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Agomelatine 138112-76-2 38958 Commercial Production [Indication]
For the treatment of major depressive episodes in adults.
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Apixaban
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Apixaban 503612-47-3 37883 Nov.26, 2026 Commercial Production [Indication]
1. To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
2. For the prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip or knee replacement surgery.
3. For the treatment of DVT and pulmonary embolism (PE).
4. For the reduction in the risk of recurrent DVT and PE.
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Atorvastatin Calcium
API’s Name CAS No. US DMF Patent Expiry Date (US) Current Status Atorvastatin Calcium 134523-03-8 29057 Commercial Production [Indication]
1. To treat high total cholesterol, low density lipoprotein cholesterol (LDL-C), apolipoprotein B, and triglycerides, and to lower high density lipoprotein (HDL) cholesterol in patients with primary hypercholesterolemia or mixed dyslipidemia.
2. To reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina in patients with coronary heart disease or multiple risk factors for coronary heart disease.