Exclusive rights such as Betmiga and Olosta expire

Blockbuster Oral Patent Expired Items, less than usual

2020 Patent-reexamination expiration product analysis, generic overheating competition will avoid

In 2020, the generics market is likely to be generally calm, with a small number of large-scale items whose exclusive rights expire.

 

Nevertheless,the exclusive right of blockbuster products like hypersensitivity bladder treatment ‘Betmiga’ (Mirabegron/Astellas), hypertension-hyperlipidemia treatment ‘Duowell’(Telmisartan, Rosuvastatin/Yuhan), anti-smoking ‘Champix’(Varenicline/Pfizer) is scheduled to expire, and fierce competition for the generic market is expected.

 

On the 6th, after expiration of PMS and patent expiration items, a number of original items such as Duowell and Champix were captured.

 

Generic drugs cannot be released until the original drug expires and the reexamination expires.

 

Moreover, because there are many kinds of patents like substances, uses, and compositions, just because one patent is terminated doesn't mean you can make generic drugs.

 

'Duowell', a hypertension-hyperlipidemic drug, is not listed on the MFDS patent list.

 

Generic applications can be applied after the re-examination expiration date which is October 30th.

 

However, it is not attractive to the first generics because more than 10 drugs similar to Duowell have already been approved for sale as data submission drugs.

 

Among the items whose PMS has expired, the substance patent of the anti-smoking drug 'Champix' expires in July.

 

Dozens of companies have already obtained approval through salt-modified drugs, and have sold them for a limited time.

 

But last month, the Patent Court raised the hands of the original drug, which prevented the sale of salt-modified drugs.

 

However, sales will be possible after July.

 

Although there is a follow-up patent, domestic pharmaceutical companies have already succeeded in avoiding patents.

 

On May 3, the overactive bladder drug 'Betmiga' will expire.

 

Although there is a follow-up patent like Champix, domestic pharmaceutical companies have been incapacitated through aggressive patent challenge, which is likely to release generic drugs within the year.

 

The anti-depressant drug 'Pristiq' (Desvenlafaxine/Pfizer) is also likely to release generics this year.

 

Pristiq's expiration date on February 5 has raised the possibility of early launch, with five domestic pharmaceuticals successfully evading patents last year.

 

In addition, the patents on birth control pills 'Yaz', 'Yasmine' (Drospirenone/Ethinyl estradiol/Bayer) and Parkinson's treatment drug 'Stalevo'( Levodopa/Carbidopa/Entacapone) are completely expired.

 

However, Stalevo has been selling products since 2015, with three companies including Jeil Pharmaceutical Co., Ltd, Myung In Pharmaceutical Co., Ltd., and Ilhwa gaining generic exclusivity permission through patent challenge.

 

In addition, the hypertension-hyperlipidemia treatment drug 'Olostar' (Rosuvastatin Olmesatanmedoxomil/Daewoong Pharm.

 

Co., Ltd) will be released this year based on the patent challenge of latecomers.