Paragraph IV certification submitted for Ruxolitinib Extended-Release Tablets ANDA; potential first-to-file eligibility

A Paragraph IV certification has been submitted for the company's ANDA for Ruxolitinib Extended-Release Tablets, relating to patents listed in the US FDA Orange Book.

Wed 7 Oct 2026

ANDA Product

Ruxolitinib Extended-Release Tablets

Regulatory Update

Paragraph IV certification submitted

Potential Exclusivity

180 days of generic drug exclusivity under US law

What was announced

• The company has submitted a Paragraph IV certification in connection with its ANDA (Abbreviated New Drug Application) for Ruxolitinib Extended-Release Tablets.
• The certification relates to applicable patents listed in the U.S. Food and Drug Administration's (FDA) Orange Book.
• The required notice has been provided to the relevant parties in accordance with applicable U.S. regulatory requirements.

What the company believes

• Based on the timing and status of its ANDA and the Paragraph IV certification, and subject to FDA review and determination, the company believes it is eligible for first-to-file status for Ruxolitinib Extended-Release Tablets.
• If confirmed by the FDA and all applicable statutory and regulatory requirements are satisfied, first-to-file status may provide eligibility for 180 days of generic drug exclusivity under U.S. law.

What this announcement is not

• The ANDA also remains subject to FDA review.
• The release states the announcement should not be construed as FDA approval of the product or confirmation by the FDA of first-to-file status or exclusivity.

Management comment

• Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, said first-to-file opportunities are an important part of the strategy to build a more differentiated and higher-value product portfolio in the U.S., and that the update reflects a focus on identifying technically and commercially attractive opportunities where development and manufacturing capabilities can create sustainable value; the company looks forward to progressing the product through the regulatory process.
• The company said it will provide further updates, as appropriate, in accordance with applicable disclosure requirements.

About the company (as stated in the release)

• Incorporated in 1991, headquartered in Hyderabad, described as a vertically integrated pharmaceutical company present across the manufacturing value chain, from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs) to Peptides CDMO.
• Products are distributed to more than 300 customers across regulated and semi-regulated markets, with global presence extending to over 80 countries and offices across India, the US and Switzerland.
• It has 10 manufacturing facilities: seven in India, two in the US and one in Switzerland.
• Regulatory approvals listed include US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

How a reader can read it

• The update is about a step in the U.S. generic approval pathway for one product; the belief about first-to-file status and the possible 180-day exclusivity are stated as conditional on FDA review and confirmation, and on all applicable requirements being satisfied.
• The release carries forward-looking statements and lists risks and uncertainties including FDA actions, patent litigation, exclusivity determinations and competition, and notes actual outcomes may differ materially.

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