Generic ‘skinny’ labelling under threat in the US

INICIO/Políticas y legislación | Posted 05/11/2021 post-comment0 Post your comment

On 2 October 2021, GlaxoSmithKlein (GSK) was finally successful in challenging generics manufacturer Teva Pharmaceuticals (Teva) over its ‘skinny’ labelling of their beta blocker carvedilol, a generic version of Coreg.

Label prescription drugs

In the US, skinny labelling was introduced to help generics manufacturers avoid patent walls, or ‘thickets’, set up by originator manufacturers. In essence, a patent wall can be created every time a drug is approved for a new indication (such as a new disease) or a new use (such as in paediatric patients). This can add another 20 years to a patent lifetime and block generics market entry. However, as approved by US congress, skinny labelling allows generics manufacturers to market a product following approval for the unpatented uses of the drug only. This enables the generics company to avoid waiting until existing patents expire and negates the need for them to attempt to invalidate patents in court.

Until now this has been a success. However, Teva has lost the battle against GSK over the skinny labeling of Coreg, used to treat patients with congestive heart failure (CHF) and other cardiovascular disorders. Teva has been requested to pay over US$20 million in damages due to patent infringement.

In 2007, Teva launched their generic version of Coreg with a skinny label that included two indications but did not include the treatment for CHF indication as this was still under patent. The CHF indication was later reissued for GSK and in 2011, the US Food and Drug Administration requested that Teva amend its label to include the patented CHF indication. Now, despite GSK initially losing the case in 2019, the US Federal Circuit has found Teva liable for inducing others, mainly physicians, to commit patent infringement by prescribing the generic form of the drug for indications not on its label (between 2008 and 2011).

It is thought that this case will have immediate ill effects for patients taking generic versions of carvedilol who may now have to switch to the more expensive brand-name version. It also has the potential to threaten other skinny labelled products on the market, and those that may seek approval in the future.

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

FDA voices concerns around drug patents and competition

European court of Justice backs UK in pay-for-delay fine against GSK

UK accuses GSK of delaying generics

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 last 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 la semana pasada: 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
Lawsuits and US$450 million payout for price fixing and delayed generics entry
34 AA010660
INICIO/Políticas y legislación Posted 29/10/2021
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