Alvogen Imbruvica Ruling Set To Push AbbVie’s Monopoly To 2032
Icelandic Firm And Partner Natco Fail With Invalidity Challenges
Alvotech and Natco have failed to persuade a US court that certain of AbbVie’s IP shielding its Imbruvica blockbuster is invalid. In response, the originator said that it did not anticipate generic competition to its branded oral therapy for treating forms of cancer until March 2032, assuming pediatric exclusivity is granted.
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Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study.
Natco says it will be entitled to 180-day exclusivity for four strengths of ibrutinib tablets in the US after receiving tentative FDA approval.
Australia’s Mayne Pharma has announced another complete response letter for its proposed generic version of Organon’s NuvaRing (etonogestrel/ethinylestradiol) contraceptive device, marking a trio of setbacks for the ANDA product.