Patent litigation to decide prospects of Olostar generic

Follow-on drug seeks approval targeting PMS expiration, ten including Kolmar challenge patent

For the first time, a generic drug with same active ingredient (olmesartan medoxomil, rosuvastatin calcium) contained in Daewoong Pharmaceutical’s blockbuster co-morbid hypertension and dyslipidemia treatment, Olostar, has applied for approval.

 

Presumably, the generic manufacturer would be either Kolmar Korea or a CMO as Kolmar Korea’s bioequivalence test protocol for the generic has been approved in last March.

 

However, the company cannot immediately release the generic product despite acquiring the item approval, because Olostar’s pharmaceutical patent is valid until Mar.

 

22 of 2033.

 

The pharmaceutical industry reported on Jan.

 

2 that olmesartan medoxomil-rosuvastatin generic has submitted an approval application to Ministry of Food and Drug Safety (MFDS).

 

As Olostar’s post-marketing surveillance period has expired on Jan.

 

28, a follow-on drug has no problem applying for approval.

 

But the generic would face restriction according to patent-approval linkage system, because the original’s drug patent is listed on MFDS’ patent list.

 

The original manufacturer may request for sales ban on generics via patent litigation.

 

And if generic manufacturer wins the patent litigation, the restriction protecting the original would be lifted.

 

Kolmar Korea has already filed negative confirmation of scope on the original to evade patent infringement on June 3 last year.

 

And Hutecs Pharmaceutical Korea, Mother’s Pharm, Daehan New Pharm, Sinil Pharmaceutical, Hana Pharm, White Life Science, Korea Prime Pharm, Hanpoong Pharm, and Crystal Life Sciences have also filed the same case.

 

Kolmar Korea has been developing the generic until now.

 

The company’s bioequivalence test protocol has been approved last March to prove equivalence between tentatively named Olmetin tablet 20/20 mg and Olostar tablet 20/20 mg in healthy adult subject.

 

Kolmar Korea has highly likely to have developed the generic drug and other patent challengers would be supplied with the contract manufactured generic.

 

Sources report review on the negative confirmation of scope filed on Olostar has almost been completed and is waiting for the last decision.

 

If Intellectual Property Trial and Appeal Board are to cite the generic manufacturer, the generics could be released after clearing the approval.

 

However, the pressure of patent infringement has not been resolved fully, yet, as the patent owner, Daewoong Pharmaceutical, has a possibility of filing an appeal at a higher instance.

 

Since the approval in July 2013, Olostar has been enjoying its success in the hypertension and dyslipidemia treatment market.

 

According to UBIST, the drug generated total 12.1 billion won of outpatient prescription volume last year, easily surpassing the standard of Korean blockbuster drug at ten billion won.

 

Definitely, the original has the marketability attracting the generics to hurry the early launch.

 

But, the success of generics in the market is not guaranteed.

 

Although a generic with the exact same substance as the original is not available at the moment, a few combination drugs with telmisartan and rosuvastatin calcium in the same class as Olostar have been released already.

 

And 11 companies are supplying the telmisartan-rosuvastatin drugs.

 

Moreover, the competition would intensify by coming October, as the original’s post-marketing surveillance period is to be expired then.

 

Other combination drug for co-morbid hypertension and dyslipidemia with amlodipine besylate and atorvastatin calcium (brand name: Caduet by Pfizer) had its post-marketing surveillance period expired in 2010 and now it has total 78 follow-on drugs.

 

Basically, the market cannot get anymore saturated.

 

Nevertheless, small and medium companies are still betting on the generic as the number of originals with soon-to-be-expired market exclusivity is limited, and an item earning over ten million won from outpatient prescription is even rarer.

 

Meanwhile, the original manufacturer is expected to take aggressive legal action against the generic manufacturers, because the generic entering the market would impact the company with drug pricing reduction.

 

Accordingly, Daewoong Pharmaceutical would likely to concentrate on patent litigation.