The patents of painkiller Lyrica and influenza therapy Tamiflu with annual sales of more than 55 billion won ($48 million) have expired or will do so soon, heralding a marketing war between originals and generics.
The domestic drugmakers have already developed generics of Lyrica whose patent expired Monday and are supplying their products as well as winning the approvals of Tamiflu whose patent expires next Tuesday.
Lyrica’s usage patent about pain expired Monday, opening the way for general products to jump into the market. Lyrica is the therapy to have indications in the treatment of neuropathic pain, epilepsy, and fibromyalgia syndrome in adults.
Korean drugmakers released Lyrica’s generics in 2012, but some of them stopped production because they lost in the usage patent suit.
Thirteen companies, including CJ HealthcareCJ헬스케어, Samjin Pharm삼진제약, Hanmi Pharm 한미약품, have sold it with the epilepsy indication. Because Lyrica has been mostly used as a painkiller in Korea, Korean products have had only half of indications.
As the usage patent expired Monday, however, it’s free to be used as a painkiller. Currently, 193 Lyrica generics were approved in the four doses of 50mg, 75mg, 150mg, and 300mg.
The composite patent of Tamiflu will expire next Tuesday.
It means the release of generics is possible. According to the approval status of the Ministry of Food and Drug Safety (MFDS)식품의약품안전처, 118 products with oseltamivir component have got approvals, including Hanmiflu, an incrementally modified drug of Hanmi Pharmaceutical.
Last year, Hanmi released Hanmiflu by changing the salt of oseltamivir hydrochloride to avoid the composite patent. After the release, it has recorded the prescription of more than 20 billion won ($17.6 million).
As the nation experienced supply shortage of Tamiflu every year, the release of generics can ensure smooth supply at lower prices.
Tamiflu has 30mg, 45mg and 75mg doses and the upper price base on 75mg dose is 2,586 won. After generic registration, its prices will go down to 2,263 won.
Generics are priced lower than Tamiflu. The lowest-priced drug among the registered drugs is Flurex Cap. by Il-Yang Pharm일양약품, whose price is 1,450 won per 75mg dose.
<© Korea Biomedical Review, All rights reserved.>