Menu

Generics

Labelling V14I26

Laws on packaging, substitution and prescription of generics in Brazil

Generics/Research | Posted 09/07/2021

According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

01 AA007239

Legal requirements on equivalence studies for generics in Brazil

Generics/Research | Posted 02/07/2021

The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999). According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

Patent 1 V13E17

Backlog of drug patents in Brazil

Generics/Research | Posted 25/06/2021

In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017 [1] showed backlogs in the analysis of patent applications in Brazil. These delays, known as ‘backlogs‘, extend the term of patents granted on medicines and delay the entry of generics into the market.

28 MD002360

Natco cancer generic approval and advances for Lannett asthma and diabetes products

Generics/News | Posted 25/06/2021

In early June 2021, US Food and Drug Administration (FDA) approved Natco Pharma’s abbreviated new drug application (ANDA) for carfilzomib vials, a generic version of anticancer drug Kyprolis. It also accepted Lannett’s ANDA for their generic version of asthma treatment Adavir Diskus, fluticasone propionate and salmeterol inhalation powder.

34 AA010660

Use of generics increases during the COVID-19 pandemic in Mexico

Generics/General | Posted 21/06/2021

During the last month of July 2020, the pharmacist sector affiliated with the National Association of Medicines Retailers (Asociación Nacional de Distribuidores de Medicina A.C, ANADIM) reported an average sales growth of 23% fostered by the demand of generic medicines. 

10 AA008993

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

Generics/News | Posted 21/06/2021

On 27 May 2021, Zydus Cadila received US Food and Drug Administration (FDA) approval to market fluphenazine hydrochloride tablets which is used to treat schizophrenia and other types of mental condition. On 7 June 2021, Lupin Ltd received approval for emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV. 

47 MD001813

Non-profit generics manufacturers in the US reduce foreign dependence

Generics/Research | Posted 11/06/2021

Non-profit generics drug manufacturers have the potential to make important contributions to reduce foreign dependence on generic drugs in the US, argues an article published in The Journal of Law Medicine and Ethics [1].

Intellectual Property V13E17

COVID-19 IP waivers could lead to global pharma patent changes

Generics/General | Posted 11/06/2021

At the Nikkei Future of Asia conference in Tokyo on 20 May 2021, Malaysian Prime Minister Tan Sri Muhyiddin Yassin announced that he believes Asia should lead in opening-up patent protections to produce generic versions of life-saving medicines. 

26 AA011066

COVID-19 favipiravir treatment production opens up in Thailand

Generics/General | Posted 04/06/2021

In Thailand, the patent application for favipiravir, a drug widely used to treat COVID-19, has been rejected. This now allows local generics production of the antiviral medication and human trials of a Thai-made version of the drug are underway.

Pay for Delay DrugsMoneyGeneric V13F21

More out-of-pocket costs for US patients with rising prescription drug prices

Generics/Research | Posted 31/05/2021

Increasing prices of brand-name drugs in the US, leaves patients with increasing costs at the pharmacy, says a study published in JAMA Network Open [1].