5 blockbuster drugs whose patents expired in 2018

According to the data reported by the EvaluatePharma, the expiration of the patent will reduce the revenue of the original research drug by $194 billion between 2017 and 2022, of which the original research drug will reduce the revenue of $31 billion in 2018 due to the expiration of the patent.

Lyrica

Pregabalin is an analog of the neurotransmitter γ-aminobutyric acid (GABA), with molecular formula C8H17NO2 and molecular weight 159.23. FDA-approved indications include diabetic peripheral neuralgia and post-herpetic neuralgia (2004/12/30), partial seizures (2005/6/10), fibromyalgia (2007/6/21), and neuropathic pain associated with spinal cord injury (2012/6/20). Since its listing, it has contributed 39.184 billion US dollars to Pfizer.

The compound patent and pain indication patent for pregabalin will expire on 12/30/2018. Prior to this, Pfizer announced on February 6, 2014 that it had won the support of the Federal Court of Appeal that generic drug manufacturers Actavis, Lupin and Teva would infringe Pfizer's above-mentioned patent rights if they listed pregabalin generic drugs. In October 2017, Pfizer introduced pregabalin sustained-release tablets, taken once a day, to relieve diabetic peripheral neuralgia and post-herpetic neuralgia, adding a buffer zone in response to competition from pregabalin generics.

　　Spiriva和Symbicort

More and more blockbuster products in the field of respiratory diseases are beginning to encounter patent cliffs. Advair lost patent protection in 2011, Xolair lost patent protection in 2017, and two blockbuster products will lose patent protection in 2018. The US market sales of Boehringer Ingelheim Spiriva (tiotropium bromide) in 2016 was US $1.9 billion. Although the patent protection was extended for 6 months due to pediatric indications, the patent protection in the US market will eventually expire on July 31, 2018. AstraZeneca Symbicort (budesonide/formoterol) sales in the US market in 2016 were US $1.4 billion, and patent protection will expire on September 9, 2018.

However, inhaled preparations have always been famous for their high difficulty in imitation. FDA even issued guidelines for imitation of respiratory preparations in 2013 to guide enterprises to develop Advair generic drugs. Even so, the sales trend after the expiration of Advair patent is very stable.

Cialis

Tadalafil's sales have been rising steadily since its launch, and it has become Lilly's second-highest-selling drug, achieving $1.5 billion in sales in the U.S. market in 2016.

On July 12, 2017, Lilly announced that it had reached a settlement with generic drug manufacturers in the Eastern District Court of Virginia in the United States. Cialis's unit dose patent (unit dose patent) will expire on September 27, 2018.

Another drug for ED, Bayer's Levitra/Staxyn (vardenafil), does not pose much competition to sildenafil and tadalafil after its listing. Its patent protection will also expire on October 31, 2018. With a large number of generic drugs about to flood the market, Levitra's market share is in jeopardy. EvaluatePharma forecast the 2022 global ED drug market size of about $3.2 billion.

　　Sensipar

Sinacalcet is a calcium sensing receptor agonist, which was first approved by FDA on March 8, 2004. Currently approved indications include secondary hyperparathyroidism in patients with chronic kidney disease undergoing dialysis, hypercalcemia in patients with parathyroid adenocarcinoma, and hypercalcemia in patients with primary hyperparathyroidism. Since its listing, it has contributed a total of 9.942 billion US dollars to Amjin.