Hikma launches HIV generic ritonavir in the US

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Hikma launches HIV generic ritonavir in the US

Genéricos/Novedades | Posted 18/05/2018 0 Post your comment

Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 20 March 2018 that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp had launched generic ritonavir tablets (100 mg) in the US.

Ritonavir is an antiretroviral medication used along with other medications for the treatment of human immunodeficiency virus (HIV-1) infection.

Hikma’s ritonavir tablets are the first AB-rated generic to AbbVie’s brand-name product Norvir (ritonavir) tablets. The US Food and Drug Administration (FDA) designates an AB-rating to generics that have submitted data demonstrating that the generic drug product is bioequivalent to other reference listed drugs and satisfies all other therapeutic equivalence criteria with respect to these reference products.

According to FDA product approval letter, West-Ward is eligible for 180 days of generics exclusivity.

US sales of Norvir in 2017 were approximately US$208.5 million, according to IQVIA.

Hikma has been expanding its presence in the generics market in the US. The company acquired some of Baxter’s injectable products sold primarily in the US back in 2011 [1]. In 2015, it acquired Boehringer Ingelheim’s US generics business: Roxane Laboratories and Boehringer Ingelheim Roxane (Roxane) [2]. The Roxane acquisition, however, has led to the loss of 200 jobs and it seems more layoffs are on the way.

Hikma is also making moves into the biosimilar space. The company signed a licensing deal with South Korean biotechnology company Celltrion in December 2017 to market a monoclonal antibody biosimilar (mAb) in the Middle East and North Africa (MENA) region [3].

References
1. GaBI Online - Generics and Biosimilars Initiative. Hikma buying into the US market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Pharma-News/Hikma-buying-into-the-US-market
2. GaBI Online - Generics and Biosimilars Initiative. Hikma to acquire Boehringer Ingelheim’s US generics business [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Pharma-News/Hikma-to-acquire-Boehringer-Ingelheim-s-US-generics-business
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar deals for Hikma and Lupin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Pharma-News/Biosimilar-deals-for-Hikma-and-Lupin

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Source: Hikma