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:
|
Generic name |
Pregabalin |
|
Company |
Pfizer |
|
Therapeutic field |
Epilepsy, neuropathic pain, and anxiety |
|
Original drug patent |
|
|
Registration application in China |
|
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.
|
Generic name |
Levetiracetam |
|
Company |
Boehringer Ingelheim |
|
Therapeutic field |
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 |
|
Original drug patent |
Its original drug patent will expire on July 30, 2018 |
|
Registration application in China |
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. ...Read More
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