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Analyzing the Most Promising Drugs That Will Lose Patent in the US & EU in 2022

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Michael
Analyzing the Most Promising Drugs That Will Lose Patent in the US & EU in 2022

For the initial developers and innovators of the drugs, patent protection results in high sales and profits. However, the initial creator faces issues as a result of generic rivals entering the market after the patent expires. The expiry of a drug's patent allows firms other than the original creator to produce lower-cost generic equivalents. Consumers benefit since it allows them to obtain vital drugs at a lesser cost, allowing them to save money. 


Each year, the patents on a number of drugs expire, resulting in the loss of exclusivity. For drug manufacture, marketing, and production, different countries have distinct norms and regulations. However, various criteria, such as Orphan Drug Exclusivity, New Chemical Exclusivity (NCE), and Pediatric Exclusivity (PED), alter the patent duration.


The global generic drugs market has grown dramatically since 2011, with sales reaching new highs with each passing year. "Generics account for more than 80% of prescription drugs in the United States, and that percentage is continuously growing," according to the FDA (2015). It has been noticed that since the introduction of generics, sales of patented drugs have decreased by 90%. Some major drugs, including AstraZeneca's Faslodex, Amerigen Pharma's Bystolic (Nebivolol), Cipla's Emtricitabine (Emtricitabine), Alvogen's Hysingla ER (Hydrocodone er), Teva's Perforomist (Formoterol), Mylan's Sutent (Sunitinib), Lannett's Zomig  ns (Zolmitriptan)  have faced patents expiration. Similarly, several major drugs are expected to lose patents in 2022 in the EU and US healthcare markets, thereby increasing the availability of generic drugs in the market.


Some of the Drugs Losing Patent Protection or Exclusivity in 2022 include:


  • Revlimid: Bristol Myers Squibb 
  • Lucentis:Roche
  • Vimpat: UCB 
  • Alimta: Eli Lilly 
  • Velcade: Takeda
  • Combigan: Allergan
  • Januvia & Janumet: Merck
  • Bevacizumab (Avastin): Roche
  • Toviaz: Pfizer

When a drug's exclusive patent expires, several manufacturers, not only the original drug developer, may take advantage of the shortened approval procedure to offer their low-cost generic equivalents or biosimilars. After a drug's patent exclusivity expires, three to five firms often apply to produce generic copies or biosimilars of the original drug. These are often the less complicated counterparts of the more difficult-to-manufacture physician-administered drugs. Consequently, the price reduction leads to increased sales and a large portion of the generic drug market captured by the pharmaceutical companies.



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