Alembic Pharmaceuticals Receives USFDA Tentative Approval for Binimetinib Tablets, 45 mg

Alembic Pharmaceuticals share price was trading higher on June 19, 2026, after the company announced that it had received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. 

The company said the product is therapeutically equivalent to the reference listed drug, Mektovi Tablets, 15 mg, of Array. 

Alembic Pharmaceuticals Receives USFDA Tentative Approval 

Alembic Pharmaceuticals announced that it has received USFDA tentative approval for Binimetinib Tablets, 45 mg. The company had previously received tentative approval for Binimetinib Tablets, 15 mg. 

Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. 

Potential 180-Day Generic Marketing Exclusivity 

According to the company, based on the FDA's Paragraph IV Certifications List, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45 mg, containing a Paragraph IV certification under the Hatch-Waxman Act. 

Upon receiving final approval from the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US market. 

Binimetinib Tablets have an estimated market size of US$259 million for the 12 months ending March 2026, according to IQVIA. 

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Alembic Pharmaceuticals USFDA Approval Portfolio 

Following this development, Alembic Pharmaceuticals has received a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals. 

Alembic Pharmaceuticals Share Price Performance 

As of 2:47 PM on June 19, 2026, Alembic Pharmaceuticals share price was trading at ₹759.00, up 1.24% from the previous close of ₹749.70. 

The stock opened at ₹749.70 and touched an intraday high of ₹768.80 and a low of ₹744.35 during the session. 

In terms of returns, the stock has gained 2.11% over the last 1 week and 1.05% over the last 1 month, while it has declined 9.39% on a year-to-date basis.  

The company's total market capitalisation stood at ₹14,922.09 crore. 

Conclusion 

Alembic Pharmaceuticals has received USFDA tentative approval for Binimetinib Tablets, 45 mg, adding to its US generic portfolio. The company said it may be eligible for 180 days of generic marketing exclusivity upon final approval of the ANDA. 

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