Is Forxiga generic same as solvate-modified drug?

Solvate-modified drug wins preferential sales right, categorizing them the same means delaying generic release by 9 months

Salt-modified drug is not considered the same, but solvate modification has no standard set by MFDS

A product image of Forxiga

Pharmaceutical companies developing generics of an antidiabetic Forxiga are concerned that the products would get struck by receive sales ban due to preferential sales rights.

 

The related criteria are not clarified enough for companies to predict the result.

 

According to the pharmaceutical industry sources on Mar.

 

29, the companies are hectic developing generic drugs sharing the same active pharmaceutical ingredient (API) with AstraZeneca’s antidiabetic treatment, sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga (dapagliflozin propanediol hydrate).

 

So far none of the companies have requested for approval review, but seven bioequivalence tests were approved to this date.

 

There are already 50 Forxiga follow-on drugs consisting of the API, dapagliflozin.

 

But these drugs do not share the same solvate as Forxiga’s (propanediol hydrate).

 

And 23 out of the follow-on drugs have received the preferential sales right.

 

Solvate is a compound of higher order created between solvent molecule and ion.

 

Generally, when a solvate consists of water molecule, it is then called hydrates.

 

They won the preferential sales rights as their request to nullify Forxiga’s second patent (to expired on Jan.

 

8, 2024) was accepted.

 

The preferential sales rights were validated as the companies won against the AstraZeneca’s appeal to overturn the decision.

 

The case is currently pending at the Supreme Court as the multinational pharmaceutical company requested for further consideration.

 

However, some generic companies are also participating in this case.

 

Generic companies plan to release their products immediately after the first substance patent (to be expired on Apr.

 

7, 2023), if the patent nullification decision is sustained.

 

But the issue is in the preferential sales rights won by the solvate-modified products.

 

When the preferential sales rights come effective, same products cannot be sold.

 

The preferential sales rights are effective from Apr.

 

8, 2023 through Jan.

 

7, 2024.

 

The generic makers are now conflicted if the generics are considered as identical to the solvate-modified product.

 

Typically, salt-modified drugs are not categorized as same as an original or generic drugs.

 

However, it is unclear whether the solvate or hydrate-modifying drug is the same drug.

 

If the generic drug is not the same drug, the patent-evading generic can be sold from Apr.

 

8, 2023, regardless of the preferential sales right.

 

Otherwise, the generics would be unable to enter the market until Jan.

 

7, 2024, and the release date would be pushed by nine months.

 

Even the industry is disputing over whether the solvate-modified drugs and generic drugs should be considered the same.

 

An industry associate explained, "If the Ministry of Food and Drug Safety (MFDS) has reviewed the solvate-modified drug based on the submitted evidence like a salt-modified drug in the first place, then it should be considered different like a salt-modified drug." On the other hand, some argue that in the U.S., a solvate-modified drug falls under the same category as a generic, therefore, it should be considered the same.

 

MFDS has yet to publish a clear guideline on the issue.

 

The ministry is to start the discussion, when the generics request for the approval.

 

With the ambiguous standard, generic makers are thinking of delaying the market release by nine months.

 

A pharmaceutical industry patent expert commented, “The conflict is deepening as the number of drugs with solvate like Forxiga is extremely limited and there has not been a case where a solvate-modified drug receiving the preferential sales rights.

 

MFDS should clarify the guideline before the generics applies for the market approval the set the order right”