Will SK hand over Xarelto generic exclusivity rights to GC?

SK Chemicals and GC Pharm discuss discussing selling generic exclusivity rights … low-dose generic to be first sold under the right from October this year

Pic.

 

of Xarelto

SK Chemicals may decide to hand over the hard-won generic exclusivity for its generic version of ‘Xarelto (rivaroxaban) 2.5mg’ to GC Pharma.

 

If GC Pharma takes over SK Chemicals’ generic exclusivity, the company will be able to enjoy market exclusivity for the low-dose Xarelto generic with Hanmi Pharmaceutical from this October to July next year.

 

According to industry sources on the 28th, SK Chemicals and GC Pharma have been actively reviewing the possibility of making a deal for SK Chemicals’ generic version of Xarelto 2.5mg.

 

Currently, SK Chemicals and Hanmi Pharmaceuticals own generic market exclusivity for Xarelto 2.5mg.

 

The products that receive the benefit are Hanmi Pharmaceuticals’ ‘Riroxban Tab.

 

2.5mg’ and SK Chemicals’ ‘SK rivaroxaban Tab.

 

2.5mg.’ The exclusivity will apply from the date Xarelto’s substance patent expires, October 4th, to July 3rd next year.

 

After successfully avoiding the formulation patent infringement for Xarelto 2.5mg in November 2015, the two companies obtained generic exclusivity by being the first to file for generic approval in July of the following year.

 

The companies finally won the long patent dispute that went up to the Supreme Court in December 2020 and was allowed to exercise their right to generic exclusivity without the burden of a reversal ruling.

 

However, the generic exclusivity owned by the two companies only applies to the 2.5mg dose, as Bayer had not registered a formulation patent for other doses of its Xarelto (10mg·15mg·20mg).

 

In other words, from October, when Xarelto’s substance patent expires, all companies will be allowed to release 10mg·15mg·20mg generics of Xarelto.

 

Still, experts interpret GC Pharm’s deal with SK Chemicals as an attempt to preoccupy the market and gain an advantage.

 

For the other doses, 56 companies have obtained approval for 146 products and are awaiting their release in October.

 

In this context, releasing the product 9 months earlier than the other competitors may provide an advantage in securing brand recognition, distribution, and positioning.

 

Experts explain that the deal also meets the needs of SK Chemicals well.

 

SK Chemicals has not applied for the approval of doses other than the 2.5mg, which suggests that SK Chemicals may not intend to enter the supersaturated market.

 

Officials from GC Pharm and SK Chemicals have said that they cannot confirm or deny issues that are currently being discussed.

 

According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year.

 

This was a 1% decrease from the 50.8 billion won in 2019.

 

In the first quarter of this year, Xarelto sold 11.9 billion won.

 

In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana, and is followed by Eliquis and Pradaxa.