AstraZeneca Secures Injunction Blocking Pharmacor’s Generic Dapagliflozin Until 2027 Patent Expiry
AstraZeneca won a Federal Court injunction blocking Pharmacor from selling or listing generic dapagliflozin in Australia until its patent expires on October 22, 2027 or trial. It also compels Pharmacor to withdraw or adjust its PBS listing applications while infringement and validity proceedings are slated for later this year.
1. Federal Court Grants Interlocutory Injunction
The Federal Court has issued an interlocutory injunction preventing Pharmacor from selling, supplying or listing its generic dapagliflozin products in Australia until AstraZeneca’s patent expires or the full trial has concluded. Justice Kylie Downes determined that AstraZeneca has established a prima facie infringement case and that allowing sales would cause irreparable harm by undermining the patent monopoly.
2. Patent Scope and Expiry
The disputed patent, AU 2003237886, covers dapagliflozin formulations and is valid until October 22, 2027. Pharmacor’s proposed products were found to fall squarely within the patent claims, prompting the court to require withdrawal or adjustment of the company’s pending PBS listing applications.
3. Market and Financial Implications
The injunction preserves AstraZeneca’s market exclusivity for its diabetes drug Forxiga in Australia, securing anticipated revenue streams from dapagliflozin sales. Pharmacor faces delayed market entry and potential compensation obligations under the court’s usual undertakings requirement.
4. Timeline for Substantive Proceedings
Both parties must propose a timetable for substantive infringement and validity hearings, currently eyed for later this year. The full trial will address the strength of Pharmacor’s invalidity defence and could ultimately determine market access for generic versions.