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Last Updated : Jun 18, 2018 10:57 PM IST | Source: Moneycontrol.com

Top selling drugs face patent expiration between 2018 and 2024, sales worth $251 bn at stake: Report

This news is a setback for big pharma companies as they were getting over the patent cliff but could be music for Indian drug makers who are in a race to launch copycat drugs.

Viswanath Pilla @viswanath_pilla
 
 
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Viswanath Pilla
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A looming patent cliff could potentially wipe off branded drug sales worth $251 billion of global pharma companies as patents of key drugs are expected to expire between 2018 and 2024, as per a report by the UK-based market intelligence firm EvaluatePharma.

The report titled 'World Preview 2018, Outlook to 2024', estimates the pharma industry to lose 25 percent of the $251 billion sales in 2023 alone due to top selling Humira and Stelara going off patent.

A patent cliff is when a firm's revenues could "fall off a cliff" when one or more established products go off-patent, since these products can be replicated and sold at much cheaper prices by generic competitors.

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Pharma companies typically enjoy patent protection that allows them marketing exclusivity for up to 20 years in order to recoup R&D costs for developing a drug.

This news is a setback for big pharma companies as they were getting over the patent cliff but could be music for Indian drug makers who are in a race to launch copycat drugs.

The period between 2011 and 2016 when hundreds of billions of dollars worth of branded drug sales lost patent protection - the period also coincides with dream run of Indian generic drug makers.

Some of the blockbuster drugs or drugs over $1 billion per year sales that became generics in that period include cholesterol drug Lipitor and blood thinner Plavix. Pfizer and Bristol-Myers Squibb/Sanofi-Aventis the makers of Lipitor and Plavix respectively have lost a large portion of their sales.

The biggest drug that faces the loss of patent exclusivity this time is Humira- the best-selling drug in the world . AbbVie reported sales of USD 18.4 billion for the autoimmune disease drug in 2017.

Although a key US patent for Humira expired in 2016, AbbVie has other patents that protect the drug through 2022.

But beginning in early 2023, Humira will face competition from biosimilars. AbbVie faces biosimilar competition later this year in Europe. Biocon and its partner Mylan are expected to benefit.

Celgene’s chemotherapy drug Revlimid, which was the second largest selling drug in the world in 2017 generated sales of $8.2 billion.

A key European patent for the blood cancer drug will expire in 2022. And while Celgene's US patents for the drug extend through 2026, the company struck a deal with Natco Pharma that allows a generic version of Revlimid to be sold in the US in limited volumes beginning in March 2022.

The other blockbuster drugs with over billion that are going off-patent including Stelara, Avastin, Rituxan, Herceptin and Enbrel.

Even with looming patent cliff - EvaluatePharma estimates the prescription drug sales expected to reach $1.2 trillion in 2024, due to novel therapies addressing key unmet needs, as well as increasing access to medicines globally.

“We are looking at an industry set to experience sales accelerating from the sluggish levels following the financial crisis, to annual compound growth of over 6 percent between now and 2024,” the report said.

However the report warned that payer scrutiny and sales losses from genericization and biosimilars will act as brakes on growth.

The report expects Novartis to be the leading prescription drug company in 2024 with sales of USD 53.2 billion, ahead of Pfizer and Roche.

Worldwide pharmaceutical R&D spend totalled $165 billion in 2017

representing an increase of 3.9 percent on the previous year.

Going forward, R&D spend is forecast to grow at a CAGR of 3.1 percent to 2024.

This is lower than the CAGR of 3.6 percent between 2010 and 2017.

"This reduction signals expectations that proportionally either companies will be improving R&D efficiencies or perhaps, that less revenue will be directed towards replenishing pipelines," the report said.

"The industry is increasingly looking towards employing big data and
predictive analytics to improve R&D efficiency and help stay ahead

in an era demanding more patient focused drug development," the report added.

ndia contract research firms as such as Syngene, Suven Life Sciences, among others are expected to benefit from big pharma efforts to contain R&D costs.

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First Published on Jun 18, 2018 10:57 pm
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