Last Updated on October 2, 2024 by The Health Master
Migraine
Lupin Limited (Lupin), a leading global pharmaceutical company, has received a significant boost in its mission to expand access to affordable medications for the treatment of epilepsy and migraine.
The US Food and Drug Administration (USFDA) has approved Lupin’s Abbreviated New Drug Application (ANDA) for topiramate extended-release capsules in four strengths: 25 mg, 50 mg, 100 mg, and 200 mg.
This approval paves the way for Lupin to launch a generic equivalent of Trokendi XR extended-release capsules, manufactured by Supernus Pharmaceuticals, Inc., offering patients and healthcare providers a more cost-effective treatment option.
Broader Treatment Options for Epilepsy and Migraines
Topiramate extended-release capsules are a versatile medication used for two primary purposes:
- Monotherapy for Epilepsy: This medication can be used as the initial single treatment for partial-onset or primary generalized tonic-clonic seizures in patients aged 6 and above.
- Migraine Prevention: Topiramate can also be a valuable tool in preventing migraine headaches.
With the availability of a generic alternative, patients struggling with epilepsy or migraines may benefit from increased affordability and potentially wider insurance coverage.
Market Potential
According to IQVIA MAT data from May 2024, Trokendi XR held an impressive market share, with estimated annual sales reaching $253 million in the US alone.
This signifies a substantial demand for topiramate extended-release capsules. By introducing a high-quality generic version, Lupin aims to make this treatment more accessible to a wider population.
Lupin’s dedication to innovation extends beyond just this generic approval.
The company, headquartered in Mumbai, India, has established itself as a transnational pharmaceutical powerhouse.
They develop and market a comprehensive range of branded and generic medications, including biotechnology products and active pharmaceutical ingredients (APIs).
Their reach extends to over 100 markets across the globe, encompassing the US, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.
This USFDA approval for Lupin’s topiramate extended-release capsules represents a significant step forward in broadening treatment options for patients with epilepsy and migraines, while aligning with Lupin’s commitment to providing high-quality, affordable medications worldwide.
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.
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