Zydus Lifesciences Settles US Patent Dispute with Astellas for USD 120 Million

1 min read     Updated on 12 Feb 2026, 08:33 AM
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Reviewed by
Shriram SScanX News Team
Overview

Zydus Lifesciences Limited has settled its US patent litigation with Astellas Pharma Inc. over Myrbetriq (Mirabegron) for USD 120 million plus ongoing licensing fees until September 2027. The settlement concludes all legal disputes between the companies and allows Zydus to continue marketing its generic Mirabegron in the United States. This resolution follows the company's earlier intimation about the patent litigation dated April 17, 2025.

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Zydus Lifesciences Limited has announced a settlement agreement with Astellas Pharma Inc. regarding the patent litigation over Myrbetriq (generic name: Mirabegron), concluding a legal dispute that began with the company's earlier intimation dated April 17, 2025. The pharmaceutical company disclosed this development through a regulatory filing under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Settlement Agreement Terms

The settlement involves both Zydus Lifesciences Limited and its wholly owned subsidiary, Zydus Pharmaceuticals USA, Inc. The financial terms of the agreement include significant payment obligations for the Indian pharmaceutical company.

Parameter: Details
Settlement Amount: USD 120 million
Additional Fees: Prepaid per unit licensing fee
Fee Period: From settlement date till September 2027
Product: Generic Mirabegron
Market: United States

Impact on Business Operations

The settlement agreement provides clarity for Zydus' operations in the US generic drug market. Under the terms, Zydus will pay Astellas an aggregate amount of USD 120 million as part of the resolution. Additionally, the company has agreed to pay prepaid per unit licensing fees on units of its generic Mirabegron sold in the US market from the date of the settlement agreement until September 2027.

Legal Resolution

This settlement concludes all litigation between Astellas and Zydus relating to Myrbetriq and Mirabegron. The agreement enables Zydus to continue marketing its generic version of Mirabegron in the United States without further legal challenges from Astellas regarding this particular product.

Confidential Terms

While the company has disclosed the key financial aspects of the settlement, other terms and conditions of the agreement remain confidential. The settlement represents a strategic resolution that allows both parties to move forward without prolonged litigation costs and uncertainties.

The announcement was signed by Dhaval N. Soni, Company Secretary and Compliance Officer, and filed with both BSE Limited and the National Stock Exchange of India Limited on February 12, 2026.

Historical Stock Returns for Zydus Life Science

1 Day5 Days1 Month6 Months1 Year5 Years
-1.76%-0.03%+1.08%-5.33%-3.14%+93.29%

Zydus Lifesciences Board Reviews Exchange Penalties for Technical Non-Compliance with Meeting Intimation Rules

2 min read     Updated on 09 Feb 2026, 01:36 PM
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Reviewed by
Ashish TScanX News Team
Overview

Zydus Lifesciences Limited's board reviewed penalties of ₹11,800 each from BSE and NSE for technical non-compliance with Regulation 29 regarding board meeting intimation. The issue arose from different holiday calendar interpretations between Ahmedabad (company's location) and Mumbai (exchanges' location) for a November 6, 2025 meeting. The board acknowledged the inadvertent error, confirmed penalty payments, and committed to strengthened compliance processes.

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Zydus Lifesciences Limited board of directors has formally reviewed and commented on penalties levied by BSE and NSE for technical non-compliance with board meeting intimation requirements under SEBI regulations.

Penalty Details and Background

Both BSE and NSE imposed penalties of ₹11,800 each (including GST) on the company through notices dated December 15, 2025. The penalties were levied for technical non-compliance with Regulation 29 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Parameter: Details
Penalty Amount (Each Exchange): ₹11,800 (including GST)
Basic Fine: ₹10,000
GST (18%): ₹1,800
Notice Date: December 15, 2025
Board Meeting Date: February 9, 2026

The non-compliance related to insufficient prior intimation for a board meeting held on November 6, 2025, which was convened to consider a fund-raising exercise. Under Regulation 29, companies must provide at least two working days' advance notice to exchanges, excluding both the intimation date and meeting date.

Timeline and Compliance Issue

Zydus Lifesciences had provided meeting intimation to both exchanges on November 3, 2025. However, a discrepancy arose regarding the interpretation of working days due to different holiday calendars.

Date: Status
November 3, 2025: Company sent intimation to exchanges
November 5, 2025: Working day in Ahmedabad (company's registered office location)
November 5, 2025: Trading holiday in Mumbai (Prakash Gurpurb Sri Guru Nanak Dev)
November 6, 2025: Board meeting held

The company considered November 5, 2025, as a working day based on the RBI holiday list for Ahmedabad, where its registered office is located. However, the exchanges treated it as a holiday due to the trading holiday in Mumbai on account of Prakash Gurpurb Sri Guru Nanak Dev.

Board's Response and Analysis

At the board meeting held on February 9, 2026, directors reviewed the notices dated December 15, 2025, and the company's replies dated December 29, 2025. The board made several key observations:

  • The technical non-compliance was inadvertent, resulting from different interpretations of holiday calendars between Ahmedabad and Mumbai
  • The company acted in good faith with no intention to deviate from regulatory requirements
  • Legal counsel's interpretation contributed to the technical error
  • The company maintains a robust compliance framework

Penalty Payment and Compliance Measures

The company has paid both penalties within the prescribed timeline as specified in the exchange notices. The board confirmed that replies were submitted to both exchanges on December 29, 2025, acknowledging the penalty payments.

Key compliance actions taken include:

  • Payment of ₹11,800 to BSE within prescribed timeline
  • Payment of ₹11,800 to NSE within prescribed timeline
  • Formal acknowledgment to both exchanges
  • Implementation of strengthened processes to prevent future technical non-compliances

Corporate Governance Commitment

The board emphasized that the company has consistently endeavored to comply with applicable rules and regulations in their true letter and spirit. Despite this inadvertent technical error, Zydus Lifesciences has undertaken necessary steps to strengthen its compliance processes.

The board reaffirmed its commitment to strong governance and regulatory adherence, ensuring that such technical discrepancies are avoided in future through enhanced process controls and clearer interpretation guidelines for holiday calendars across different locations.

Historical Stock Returns for Zydus Life Science

1 Day5 Days1 Month6 Months1 Year5 Years
-1.76%-0.03%+1.08%-5.33%-3.14%+93.29%

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1 Year Returns:-3.14%