Alembic Pharmaceuticals received tentative USFDA approval for generic Binimetinib 45 mg tablets, securing potential eligibility for 180-day exclusivity in the U.S. market.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Alembic Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The approval marks another step in the company’s expanding U.S. oncology portfolio and could provide a valuable commercial advantage if final approval is granted.
The tentative approval follows an earlier tentative approval for Alembic’s Binimetinib Tablets, 15 mg. The product is a generic version of Mektovi® (binimetinib) Tablets, marketed by Array BioPharma, a subsidiary of Pfizer.
According to the company, Alembic is the sole first applicant to have submitted an ANDA for Binimetinib 45 mg tablets with a Paragraph IV certification under the Hatch-Waxman Act. As a result, the company may qualify for 180 days of generic marketing exclusivity in the United States once the product receives final approval.
About Binimetinib
Binimetinib is a MEK inhibitor that blocks signaling within the MAPK pathway, a key driver of tumor growth in cancers harboring BRAF mutations. The drug is administered in combination with the BRAF inhibitor encorafenib to provide dual pathway inhibition and improve treatment outcomes.
The therapy is approved for patients with unresectable or metastatic melanoma carrying a BRAF V600E or V600K mutation. It is also approved, in combination with encorafenib, for adults with metastatic non-small cell lung cancer (NSCLC) harboring a BRAF V600E mutation.
BRAF mutations occur in a subset of melanoma and lung cancer patients and are associated with abnormal cellular signaling that promotes tumor proliferation. Targeted therapies such as binimetinib and encorafenib have significantly improved treatment options for these patients.
Regulatory and Market Significance
A tentative approval indicates that the ANDA has met the FDA’s scientific and regulatory requirements for quality, safety, and bioequivalence but cannot receive final approval until applicable exclusivity or patent barriers are resolved.
Alembic’s first-to-file status could provide a substantial commercial opportunity. Under the Hatch-Waxman framework, eligible first applicants may receive six months of generic exclusivity before additional generic competitors enter the market.
According to IQVIA data cited by the company, Binimetinib tablets generated an estimated U.S. market opportunity of approximately $259 million during the twelve months ending March 2026.
Expanding U.S. Generic Portfolio
The latest approval further strengthens Alembic’s presence in the U.S. generics market, particularly within oncology and specialty pharmaceuticals. The company now holds a cumulative total of 242 USFDA ANDA approvals, including 222 final approvals and 20 tentative approvals.
Regulatory Path Forward
Alembic’s next milestone will be securing final FDA approval for Binimetinib 45 mg tablets once all regulatory and patent-related requirements are satisfied. If approved, the company could become the first generic entrant in the market for this strength, potentially benefiting from 180 days of exclusive generic sales before broader competition emerges.
Reference
Alembic Pharmaceuticals Limited announces USFDA Tentative Approval for Binimetinib Tablets, 45 mg.
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.
