Lawsuits and US$450 million payout for price fixing and delayed generics entry

INICIO/Políticas y legislación | Posted 29/10/2021 post-comment0 Post your comment

In late September 2021, Gilead Sciences, Teva and Bristol Myers Squibb, were sued by US pharmacy chains related to delayed launch of HIV generics. In early October 2021, three generics drugs companies, Taro Pharmaceuticals USA, Novartis’ Sandoz and Apotex agreed to pay almost US$450 million to resolve alleged claims that they illegally collaborated on price, supply and allocation of numerous medications.

34 AA010660

Gilead Sciences, Teva and Bristol Myers Squibb sued
The lawsuit launched by major US pharmacy chains CVS and Rite Aid against Gilead Sciences, Teva and Bristol Myers Squibb specifically desires billions of dollars’ worth of reverse-payment agreements between the trio, that led to the withholding of generic versions of HIV drugs Viread, Atripla, Truvada and Evotaz from the market.

It is alleged that between 2004 to 2017, Gilead made tens of billions of dollars from HIV medications while introducing only a single new pharmaceutical compound. In addition, Gilead engaged in settlement agreements, collusive collaborations and product-hopping schemes whilst unfairly increasing the exorbitant pricing for its HIV medications, prior to generics market entry. Gilead is also accused of suppressing competition of certain drugs and of collaborating with Teva to not launch generic versions. Gilead collaborated with Bristol Myers Squibb to develop some of the HIV drugs, yet the suit argues that these were in fact created by Czech institution in the 1980s.

Illegal collaboration of Taro Pharmaceuticals USA, Novartis’ Sandoz and Apotex
The US$450 million to be paid by Taro Pharmaceuticals USA, Novartis’ Sandoz and Apotex is in addition to the more than US$400 million already paid by the trio in criminal penalties related to price fixing. In addition, the companies have entered a five-year corporate integrity agreement, which includes internal monitoring and price transparency provisions, among other checks and balances.

Taro will pay over US$200 million, for alleged violations involving the non-steroidal drug etodolac, and nystatin-triamcinolone cream and ointment to treat skin infections. Sandoz will pay US$185 million due to alleged issues with benazepril HCTZ, used to treat hypertension, and clobetasol, a corticosteroid used to treat skin conditions. Apotex will pay US$49 million in connection with its sale of pravastatin, a drug used to treat high cholesterol and triglyceride levels.

Related articles
FDA voices concern around drug patents and competition

FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin

Teva launches first Truvada and Atripla generics and two digital inhalers

Sun Pharma ends attempt to gain full control of Taro

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View this week’s headline article: Los datos apoyan la intercambiabilidad de los biosimilares de la UE

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

LATIN AMERICAN FORUM

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de esta semana: Los datos apoyan la intercambiabilidad de los biosimilares de la UE

Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

  

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Generic ‘skinny’ labelling under threat in the US
Label prescription drugs
INICIO/Políticas y legislación Posted 05/11/2021
FDA publishes final Q&A on biosimilar development and the BPCI Act
Question-Fimea-V15E29
INICIO/Políticas y legislación Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
INICIO/Políticas y legislación Posted 08/10/2021
USA BIOSIM Act introduction
02 AA010638
INICIO/Políticas y legislación Posted 17/09/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010