USFDA approval granted for Eslicarbazepine Acetate Tablets

USFDA approval is a significant achievement for any pharmaceutical company

March 29, 2024

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Last Updated on December 22, 2024 by The Health Master

USFDA approval

Global pharmaceutical giant Lupin Limited has achieved a significant milestone with the recent announcement of United State Food and Drugs Administration approval (USFDA approval) for its Abbreviated New Drug Application (ANDA) for eslicarbazepine acetate tablets.

This USFDA approval allows Lupin to market a generic equivalent of Aptiom tablets, a product of Sumitomo Pharma America, Inc., in various strengths ranging from 200 mg to 800 mg.

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Understanding Eslicarbazepine Acetate Tablets

Eslicarbazepine acetate tablets are a crucial medication used in the treatment of partial-onset seizures in patients aged 4 and above.

These tablets play a vital role in managing epilepsy, offering patients a means to control their condition and improve their quality of life.

Importance of USFDA Approval

USFDA approval is a significant achievement for any pharmaceutical company.

It signifies rigorous testing and evaluation, ensuring the safety and efficacy of the medication.

For Lupin Limited, this USFDA approval opens doors to a wider market and underscores its commitment to providing high-quality healthcare solutions.

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Generic Equivalents

As one of the first ANDA applicants, Lupin Limited may qualify for 180 days of shared generic exclusivity.

This period allows the company to market its generic version of eslicarbazepine acetate tablets without competition, providing an opportunity for market penetration and revenue generation.

Manufacturing at Lupin’s Pithampur Facility

Lupin’s commitment to quality extends to its manufacturing facilities, with the approved product set to be manufactured at its state-of-the-art facility in Pithampur, India.

This facility adheres to stringent quality standards, ensuring the production of safe and effective medications.

Indications for Eslicarbazepine Acetate Tablets

Eslicarbazepine acetate tablets are specifically indicated for the treatment of partial-onset seizures, addressing a critical need in epilepsy management.

By offering multiple strengths, physicians can tailor dosage regimens to individual patient requirements, optimizing treatment outcomes.

Market Insights

The approval of eslicarbazepine acetate tablets represents a significant opportunity for Lupin Limited.

With estimated annual sales of USD 354 million in the US alone, the market potential for this medication is substantial.

Lupin’s entry into this space is poised to drive competition and enhance accessibility for patients.

Future Prospects

Looking ahead, Lupin Limited remains poised for continued growth and innovation.

The approval of eslicarbazepine acetate tablets is just one example of the company’s dedication to advancing healthcare solutions.

With a strong pipeline of products and a global presence, Lupin is well-positioned to shape the future of the pharmaceutical industry.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.