AstraZeneca Xigduo’s latecomers consecutively approved

24 companies approved for their Xigduo latecomers including CMO… available for sale from April 2023

AstraZeneca’s SGLT-2 inhibitor diabetes combination,

Latecomers of AstraZeneca’s SGLR-2 antidiabetic combination therapy ‘Xigduo XR (dapagliflozin propanediol/metformin) are receiving approval.

 

Due to the patent period set for the original’s substance patent, the latecomers will only be available for sale from April 2023, however, due to its commerciality and patent issues, companies are racing to commercialize their latecomers.

 

According to the industry on the 24th, four companies including KyungDong Pharm have recently received approval for their Xigduo latecomers.

 

The approved drugs are fixed combinations of dapagliflozin L-proline and metformin hydrochloride.

 

The latecomers contain a different active ingredient solvate from the original Xigduo XR tab.

 

With the addition of the 4 companies, a total of 24 companies have now received approval for Xigduo XR latecomers.

 

However, only three companies will be manufacturing the drugs.

 

Richwood Pharmaceutical, the first company to receive approval in October, Chong Kun Dang that completed independent development in November, and KyungDong Pharm will be manufacturing the latecomers.

 

Richwood Pharmaceutical’s latecomer is a combination of dapagliflozin citric acid and metformin hydrochloride and Chong Kun Dang’s is a combination of dapagliflozin and metformin hydrochloride, all of which use a different solvate from the original drug.

 

The drugs decided to use a different solvate to evade the solvate patent.

 

The patent was set to expire on June 21st, 2027, but the invalidation claims filed by latecomers in Korea have been accepted and therefore invalidated.

 

Latecomer companies have also filed and won the first and second trials to invalidate Xigduo’s second substance patent that is to expire on January 8th, 2024.

 

Therefore, the possibility of invalidating the patent is rising, raising the probability of latecomers being sold from April 7th, 2023 after the expiry of the first substance patent.

 

Even if this becomes a reality, around 2 years are still left until the companies may release the latecomers.

 

However, the companies have initiated their development early as Xigduo’s outpatient prescription last year amounted to 28.6 billion won (UBIST), and the PMS expiry date for latecomers was due November 26th, 2019.

 

If some companies obtain generic exclusivity, the release date of the other companies' products could be further delayed.

 

At the time of development, there were no restrictions regarding consigned bioequivalence studies, therefore many companies have made CMO agreements to outsource their products.

 

Richwood Pharmaceutical has orders from18 companies and KyungDong Pharm from 3 companies to produce Xigduo latecomers.