Shilpa Medicare has received an ex-parte ad-interim injunction order from the Delhi High Court regarding pharmaceutical products containing Ruxolitinib compound. The injunction, dated December 29, 2025, restrains the company and its subsidiaries from manufacturing, stockpiling, exporting, or supplying products containing this compound due to alleged patent infringement.

Court Order Details

The Delhi High Court has issued a restraining order against Shilpa Medicare Limited, along with its material subsidiary Shilpa Pharma Lifesciences Ltd and wholly owned subsidiary FTF Pharma Pvt Ltd. The injunction specifically prohibits these entities from manufacturing, stockpiling, importing, selling, offering for sale or supply, and exporting Ruxolitinib in any form beyond what is permissible under Section 107A of the Patent Act, 1970.

Inspection and Compliance

Following the court order, a Local Commissioner and team visited the company's office premises to conduct inspections. During this visit, officials took relevant copies of ledgers, stock registers, and other documentation. The company reported full cooperation with officials during the proceedings and responded to all clarifications and details sought by the inspection team.

Company's Position and Impact

Shilpa Medicare has clarified that the Ruxolitinib product in question was utilized exclusively for research purposes. The company emphasized that there is no financial impact expected from this development, and business operations continue as usual without disruption from the court proceedings.

Legal Response and Next Steps

The company has duly acknowledged receipt of the ex-parte ad-interim injunction order and has taken necessary steps to comply with all directions contained therein. Shilpa Medicare is currently evaluating its legal options, including the possibility of filing appropriate responses or appeals, as advised by legal counsel. The company disclosed this information in compliance with Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Shilpa Medicare has achieved a significant regulatory milestone with the approval of its Rotigotine transdermal patch in Europe. This marks the company's first approval for this specialized neurological treatment product in the European market, opening new avenues for growth in the pharmaceutical sector.

Product Details and Market Opportunity

The Rotigotine transdermal patch represents a sophisticated drug delivery system designed for neurological applications. Shilpa Medicare has identified substantial market potential for this product, with estimates indicating a total addressable market of approximately USD 222 million.

Launch Timeline and Strategic Positioning

Shilpa Medicare plans to launch the Rotigotine transdermal patch by FY27. This timeline allows the company to prepare its manufacturing capabilities, establish distribution networks, and ensure compliance with European regulatory requirements.

The transdermal patch technology offers several advantages in drug delivery, particularly for neurological conditions where consistent medication levels are crucial for patient outcomes. This approval positions Shilpa Medicare to compete in the specialized pharmaceutical segment focused on advanced drug delivery systems.

Market Impact and Growth Prospects

The European approval represents a strategic expansion for Shilpa Medicare into high-value pharmaceutical products. The USD 222 million market potential indicates significant revenue opportunities for the company as it establishes its presence in the European neurological treatment market.

This regulatory success demonstrates the company's capability to develop and gain approval for complex pharmaceutical products that meet stringent European standards. The achievement could serve as a foundation for future product approvals and market expansion initiatives in the region.