Zydus Lifesciences wins FDA approval for Amantadine Capsules, secures 180-day exclusivity

Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has achieved a significant regulatory milestone by receiving final approval from the United States Food and Drug Administration (USFDA) for Amantadine extended-release capsules, 68.5 mg. The company has also secured tentative approval for the 137 mg dosage. The drug, which will be marketed under the brand name Gocovri (amantadine), is intended for the treatment of dyskinesia associated with Parkinson’s disease in patients undergoing levodopa-based therapy, with or without additional dopaminergic medications.

Detailed Insights on Amantadine Extended-Release Capsules

Amantadine is a well-known antiviral and antiparkinsonian agent. Its extended-release formulation helps manage dyskinesia—a common side effect of Parkinson’s disease treatments—by providing a more consistent therapeutic effect compared to immediate-release formulations. The 68.5 mg dosage will be available with 180 days of exclusivity, a strategic advantage that allows Zydus to capture a significant share of the market without immediate generic competition.

Manufacturing and Market Impact

The Amantadine extended-release capsules will be manufactured at Zydus’s formulation manufacturing facility located in Ahmedabad SEZ – II, India. This facility is part of Zydus’s broader strategy to enhance its manufacturing capabilities and ensure high-quality production standards. The choice of this facility underscores Zydus’s commitment to leveraging its extensive infrastructure to support its global market aspirations.

Milestone and Future Outlook

This approval represents a major milestone for Zydus, marking the company’s 400th regulatory approval. Since beginning its filing process in fiscal year 2003-04, Zydus has submitted over 465 Abbreviated New Drug Applications (ANDAs), highlighting its proactive approach to expanding its product portfolio. The approval reflects Zydus’s ongoing investment in research and development, aimed at addressing unmet medical needs and improving patient outcomes.

Regulatory and Competitive Landscape

The USFDA’s approval of Amantadine extended-release capsules is particularly notable as it positions Zydus to effectively compete in the US market, which is one of the largest and most lucrative pharmaceutical markets globally. By obtaining exclusivity, Zydus not only secures a competitive edge but also solidifies its reputation as a key player in the global pharmaceutical sector.

Broader Implications for Parkinson’s Disease Management

Parkinson’s disease is a progressive neurological disorder characterized by tremors, rigidity, and bradykinesia. Dyskinesia, a common complication of long-term levodopa therapy, can significantly impact a patient’s quality of life. The introduction of Amantadine extended-release capsules offers a new therapeutic option, potentially improving symptom management and providing patients with better control over their condition.