Patents for representative DM drugs are expected to expire

one after another

79 products and 159 patents expire in 2022

14 Galvus Generics will be released

Competition started in earnest at the beginning of the year

Next year, patents for DPP-4 inhibitor-based diabetes treatments such as Tenelia, Onglyza and Galvus will be released one after another.

 

It is predicted that generic companies will join the domestic DPP-4 inhibitor-affiliated diabetes treatment market, which has grown to 600 billion won a year.

 

In the case of generics for Galvus, more than 10 pharmaceutical companies are expected to release generics after January.

 

More than 30 companies are expected to release generics for Tenelia after October.

 

◆Ahn-gook and Hanmi will launch generic for Galvus in January, and 12 companies will join in March According to the MFDS on the 28th, there are a total of 159 patents for medicines that expire next year.

 

One or more patents for 79 products are scheduled to expire next year.

 

The pharmaceutical industry's attention is focused on diabetes treatments based on DPP-4 inhibitors.

 

This is because patents for major treatments that have emerged in earnest since the late 2000s will expire one by one from next year.

 

The first product whose patent expires is Novartis' Galvus.

 

On March 4 next year, material patents for Galvus and Galvusmet will expire.

 

According to UBIST, a pharmaceutical market research firm, the total prescription amount of Galvus and Galvusmet reached 44.5 billion won as of last year.

 

At the same time as the patent expires, 14 companies are expected to compete for generics.

 

Among them, Ahn-gook and Ahn-gook newpharm succeeded in invalidating 55 days of the extended duration of material patents by winning the patent dispute between Novartis and the Supreme Court.

 

Ahn-gook and Ahn-gook newpharm received the generic for exclusivity until May 29 next year.

 

Hanmi Pharmaceutical also won the dispute with Novartis, eliminating concerns over patent infringement.

 

Hanmi Pharmaceutical was approved for a single drug only by salt change.

 

It can be sold regardless of Ahn-gook's generic for exclusivity.

 

◆Material Patent for Tenelia, Expired in October, many generics will be released In the fourth quarter of next year, patents for Tenelia, another DPP-4 inhibitor-based diabetes treatment, and Onglyza and Kombiglyze will expire.

 

Tenelia's material patent expires on October 25.

 

Generics overcame all other patents except material patents.

 

This means that generics can be released immediately when only material patents expire.

 

Generics succeeded in invalidating Tenelia's salt patent in December 2019.

 

Since then, MTPK, the original company, has appealed, but even the patent court has sided with generic companies in September this year.

 

The ruling was then finalized when MTPK gave up its appeal to the Supreme Court.

 

Since the Tenelia patent has been invalidated, companies that are not involved in patent disputes after the expiration of the substance patent in October can also launch generic products.

 

Generic competition is expected to be fiercer than other cases.

 

In Korea, 34 companies have already been approved for related generics.

 

◆Onglyza patent expires in December In December next year, AstraZeneca's DPP-4 inhibitors, Onglyza and Kombiglyze, will expire.

 

In the case of Onglyza, there are no patents other than material patents.

 

Kombiglyze, a combination drug, had one drug license, but it already expired in March 2019.

 

Generic can be released immediately when the material patents of the two products expire.

 

However, generic's interest in Onglyza and Kombiglyze does not seem to be greater than other drugs.

 

None of the pharmaceutical companies have been approved for related generics yet.

 

It is said that no place is preparing for a related biological equivalence test.

 

The total prescription amount for Onglyza and Komblyze last year was 27.6 billion won.