Patent protection is crucial to an original drug; according to previous experience, the sales of a drug may plummet after its patent expires. Then, which blockbuster drugs will become off-patent in 2018? I’d like to give an overview thereof here from aspects of sales, relevant patents, therapeutic fields, and registration application situation in China, etc.
1. Pregabalin
The 2017 global sales of the drug reached up to USD 5 billion, and its patent protection will expire on December 30, 2018, with the relevant details as shown in the following table:
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Generic name
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Pregabalin
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Company
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Pfizer
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Therapeutic field
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Epilepsy, neuropathic pain, and anxiety
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Original drug patent
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- USR41920 expired
- US6001876 expired
- US6197819 to expire on December 30, 2018
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Registration application in China
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- In China, only Chongqing Succeway Pharmaceutical Co., Ltd. has received the approval numbers for API and preparation from the State Drug Administration of China (SDA).
- Qilu Pharmaceutical (Hainan) Co., Ltd., Jiangsu Nhwa Pharmaceutical Co., Ltd., Double-Crane Pharmaceutical (Shangqiu) Co., Ltd., and Haimen Wisdom Pharmaceutical Co., Ltd., etc. filed generic drug applications in 2017
- Zhejiang Huahai Pharmaceutical Co., Ltd. filed the generic drug application in 2016
- Shaanxi Dasheng Pharmaceutical Tech Co., Ltd. filed the Class 6 chemical drug application in 2014
- Sichuan Xinkaiyuan Pharmaceutical Co., Ltd. filed the Class 6 chemical drug application in 2013
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2. Levetiracetam
There have been successive products confronted with patent cliff in the respiratory system disease treatment field in recent years, from fluticasone propionate/salmeterol in 2011, to omalizumab in 2017, then to levetiracetam of Boehringer Ingelheim this year, to the drug budesonide/formoterol of AstraZeneca to introduce next, etc., which all became or will become off-patent. Levetiracetam achieved USD 3 billion sales last year.
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Generic name
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Levetiracetam
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Company
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Boehringer Ingelheim
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Therapeutic field
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An anticholinergic drug for bronchiectasis, clinically mainly used as the maintenance therapy of chronic obstructive pulmonary disease (COPD), including chronic bronchitis, maintenance treatment of emphysema accompanied with dyspnea and prevention of acute attack
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Original drug patent
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Its original drug patent will expire on July 30, 2018
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Registration application in China
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Lianyungang Runzhong Pharmaceutical Co., Ltd., Zhejiang Xianju Pharmaceutical Co., Ltd. and Nanchang Helioeast Pharmaceutical Co., Ltd. have received the API production approvals, and Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Nanchang Helioeast Pharmaceutical Co., Ltd., and Zhejiang Xianju Pharmaceutical Co., Ltd. have received the production approvals for levetiracetam powder for inhalation. Registration and application information regarding this drug cannot be found for other companies in China.
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3. Budesonide/Formoterol
This drug is a combination drug that is also used to treat the respiratory system disease, with 2017 sales of USD 2.8 billion. The patent expiration is not expected to cause large impacts to this drug in a short term, as powder for inhalation is much difficult to imitate.
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Generic name
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Budesonide/ Formoterol
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Company
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AstraZeneca
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Therapeutic field
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1. Asthma: this drug is applicable to the conventional treatment of asthma patients who need to use inhaled corticosteroid and long-acting β2-receptor agonist in combination.
2. COPD: symptomatic treatment for patients with COPD accompanied by recurrent exacerbations.
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Original drug patent
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- US7367333 to expire on November 11, 2018
- US7587988 to expire on April 10, 2026
- US7759328 to expire on January 29, 2023
- US7967011 to expire on August 11, 2021
- US8143239 to expire on January 29, 2023
- US8387615 to expire on March 26, 2027
- US8528545 to expire on October 16, 2028
- US8575137 to expire on January 29, 2023
- US8616196 to expire on April 7, 2029
10）US8875699 to expire on November 10, 2024
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Registration application in China
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- Beijing Alisi Clinical Studies Co., Ltd. filed the Class 3 generic drug application in 2000
- Only the original drug company AstraZeneca has received the approval for Budesonide/Formoterol Power for Inhalation in China
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4. Tadalafil
Tadalafil is a small molecule drug used to treat ED, with 2017 sales of USD 2.3 billion. Generally, the barriers to imitate small molecule drugs are low, which can be seen from the application and registration situation in China. The rapid catching up by the generic drugs after patent expiration of the original drugs will greatly impact the sales of the latter, for example, generic drugs were rapidly marketed after Pfizer’s sildenafil of the same therapeutic field (with tadalafil) became off-patent, resulting in the sales thereof to largely decline.
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Generic name
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Tadalafil
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Company
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Eli Lilly
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Therapeutic field
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Erectile dysfunction and pulmonary arterial hypertension
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Original drug patent
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- US5859006 expired on May 21, 2018
- US6821975 to expire on November 19, 2020
- US6943166 to expire on April 26, 2020
- US7182958 to expire on April 26, 2020
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Registration application in China
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- Nanjing Zenkom Pharmaceutical Co., Ltd., Yichang Tianren Pharmaceutical Co., Ltd., Wuhan Humanwell Pharmaceutical Co., Ltd., Wuhan Dinuo Pharmaceutical Limited by Share Ltd., Jiangsu Tasly Diyi Pharmaceutical Co., Ltd., Zhejiang Yongning Pharmaceutical Co., Ltd., Chongqing Huapont Pharmaceutical Co., Ltd., and Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., etc. have filed generic drug applications of tadalafil in 2018;
- Qilu Tianhe Pharmaceutical Co., Ltd., Qilu Pharmaceutical (Hainan) Co., Ltd. and Changchun Haiyue Pharmaceutical Co., Ltd., etc. filed generic drug applications in 2017;
- Sichuan Baili Pharmaceutical Co., Ltd., Qingdao Jinfeng Pharmaceutical Co., Ltd., Jilin Yimintang Pharmaceutical Co., Ltd., and Nanjing Zenkom Pharmaceutical Co., Ltd., etc. filed generic drug applications in 2016.
- Haidashe Huage Pharmaceutical Co., Ltd., Xiangbei Welman Pharmaceutical Co., Ltd., and Hainan Jinrui Pharmaceutical Co., Ltd. filed Class 6 generic drug applications in 2015.
- Shanxi Pude Pharmaceutical Co., Ltd., Jiangxi Qingfeng Pharmaceutical Co., Ltd., Guangzhou Regenex Pharmaceuticals Ltd., and Nanjing Baijingyu Pharmaceutical Co., Ltd. filed Class 3 generic drug applications in 2014.
- Chengdu Zekangtang Pharmaceutical Technology Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd., China Resources Saike Pharmaceutical Co., Ltd., and Chengdu Suncadia Medicine Co., Ltd., etc. filed Class 3 generic drug applications in 2013.
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5. Cinacalcet
This drug is also a small molecule chemical drug that can activate the calcium receptors in parathyroid glands to reduce the secretion of parathyroid hormone (PTH), with (2017) sales of USD 1.5 billion.
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Generic name
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Cinacalcet
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Company
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Amgen
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Therapeutic field
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1) This drug is used to treat the secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on dialysis;
2) It is used to treat the hypercalcemia in patients with parathyroid carcinoma;
3) It is used to treat severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy
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Original drug patent
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- US6011068 expired on March 8, 2018
- US7829595 to expire on September 22, 2026
- US9375405 to expire on September 22, 2026
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Registration application in China
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- Kyowa Hakko Kirin China Pharmaceutical Co., Ltd. has filed the API application in 2018;
- Beijing Tide Pharmaceutical Co., Ltd. filed the Class 6 generic drug application in 2016;
- There were many (6) companies that filed generic drug applications in 2015: Jiangsu Jiayi Pharmaceutical Co., Ltd., Beijing Sihuan Pharmaceutical Co., Ltd., Jiangsu Shenlong Pharmaceutical Co., Ltd., Changzhou Sunlight Pharmaceutical Co., Ltd., Hebei Renhe Yikang Pharmaceutical Co., Ltd., and Langfang Gaobo Jingband Pharmaceutical Co., Ltd.;
- There were 8 companies that filed generic drug applications in 2014: Yueyang Hudex Pharmaceuticals Ltd., Qingdao Jinfeng Pharmaceutical Co., Ltd., Beijing Winsunny Pharmaceutical Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., 3SBio Inc., Guangzhou Nanxin Pharmaceutical Co., Ltd., Shangyu Jingxin Pharmaceutical Co., Ltd., and Fuan Pharmaceutical (Group) Co., Ltd.
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We can see from the above 5 drugs that there are not so many Chinese enterprises filing generic drug applications for biological drugs and high-end preparations that have high barriers for imitation, therefore, the patent expiration may have limited impacts on the sales, while clearly, there are many Chinese enterprises filing generic drug applications for small molecule chemical drugs that have low barriers for imitation, and the patent expiration will cause large impacts to the sales. Any error or omission pointed out and corrected for the above information will be much appreciated.
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