Regulatory Approval

Alembic Pharmaceuticals Receives USFDA Tentative Approval for Binimetinib Tablets 45 mg

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Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The company is the sole first applicant for the product with a Paragraph IV certification and could become eligible for 180 days of generic marketing exclusivity in the United States upon final approval.

PRICE-SENSITIVE TRIGGER

Event: USFDA Tentative Approval for Binimetinib Tablets, 45 mg

Type: Regulatory Approval

Impact: Positive

Immediate Effect: The approval strengthens Alembic’s US generics pipeline and positions the company for a potential first-to-file opportunity with possible 180-day generic exclusivity following final USFDA approval.

Key Metrics:

Product: Binimetinib Tablets, 45 mg
Reference Drug: Mektovi® Tablets
Estimated US Market Size: US$259 million (12 months ended March 2026, IQVIA)
Potential Exclusivity Period: 180 days (subject to final approval)
Total USFDA ANDA Approvals: 242
Final Approvals: 222
Tentative Approvals: 20

Highlight:

Binimetinib Tablets recorded an estimated US market size of approximately US$259 million for the twelve months ended March 2026, according to IQVIA data.

What Happened ?

Alembic Pharmaceuticals announced that it has received tentative approval from the USFDA for its ANDA for Binimetinib Tablets, 45 mg.

The investment is intended to secure approximately 10 MW of additional renewable power supply for the Bharuch plant. Combined with the earlier approvThe product is therapeutically equivalent to the reference listed drug Mektovi® Tablets and is indicated, in combination with encorafenib, for the treatment of patients with certain BRAF-mutated cancers, including unresectable or metastatic melanoma and metastatic non-small cell lung cancer (NSCLC).al of ₹87 crore announced in March 2026, the total approved investment now stands at ₹105 crore.

According to the FDA’s Paragraph IV Certifications List, Alembic is the sole first applicant for the 45 mg strength and may qualify for 180 days of generic marketing exclusivity in the United States upon receipt of final approval.

Key Details

Approval Details and Strategic Importance:

Received USFDA tentative approval for ANDA Binimetinib Tablets, 45 mg.
Product is therapeutically equivalent to Mektovi® Tablets.
Alembic had previously received tentative approval for the 15 mg strength.
Binimetinib is used in combination with encorafenib for certain BRAF-mutated cancer indications.
Alembic is the sole first applicant for the 45 mg strength with Paragraph IV certification.
Potential eligibility for 180-day generic marketing exclusivity upon final approval.
Estimated US market size for the product is US$259 million.
Expands Alembic’s oncology-focused US generics portfolio.
Total cumulative USFDA ANDA approvals now stand at 242.

Note:

The first-to-file status significantly enhances the strategic value of the approval as it may provide a temporary exclusivity window in the US generic market, potentially improving commercialization economics upon launch.

Risk Analysis

Summary:

The approval remains tentative and commercial launch is contingent upon receipt of final USFDA approval and resolution of any remaining regulatory or patent-related requirements.

Key Risks:

Tentative approval does not permit immediate commercial marketing.
Final approval timeline remains dependent on USFDA processes.
Paragraph IV products may face patent-related legal developments.
Market opportunity may change before commercial launch.
Competitive generic entries could impact long-term pricing and market share.

Worst Case:

If final approval is delayed or exclusivity benefits are not realized, the expected commercial opportunity from the product launch may be reduced despite the tentative approval.

Worst Case: Medium

Company Commentary

Alembic has received USFDA tentative approval for Binimetinib Tablets, 45 mg.
The product is therapeutically equivalent to Mektovi® Tablets.
The company is the sole first applicant with Paragraph IV certification for the 45 mg strength.
Alembic may be eligible for 180 days of generic marketing exclusivity upon final approval.
Binimetinib Tablets represent an estimated US$259 million market opportunity.
Alembic’s cumulative USFDA ANDA approvals have reached 242, including 222 final approvals and 20 tentative approvals.

Official Exchange Filing: Alembic Pharmaceuticals Limited

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