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Hikma launches US ritonavir exclusively

Executive Summary

Hikma has through its US West-Ward Pharmaceuticals subsidiary launched “the first AB-rated generic” version of AbbVie’s Norvir (ritonavir) 100mg tablets. According to the US Food and Drug Administration (FDA) approval letter, the Jordanian firm was the “first applicant to submit a substantially complete abbreviated new drug application (ANDA) for ritonavir 100mg [tablets], with one or more paragraph IV certifications”. Therefore, the agency noted, Hikma was eligible for 180-days of exclusivity.

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