Generic drugs copying Pfizer’s Eliquis (ingredient: apixaban), a non-vitamin K antagonist oral anticoagulant (NOAC), have obtained approval from the government.

The Ministry of Food and Drug Safety on Friday approved Inist Biopharma’s Elixaban Tab. 5mg, Samjin Apixaban Tab. 2.5mg•5mg, and Antixaban Tab. 2.5mg•5mg.

The green light came after the reevaluation of the post-marketing surveillance (PMS) on Eliquis was completed on Nov. 2.

Chong Kun Dang, Yuyu Pharma, Sinil Pharm, Huons, and Inist Biopharma have been preparing the generics since they received approval for bioequivalence tests last year.

Among them, Inist Biopharma was the first to get the regulator’s nod.

Samjin Pharma and Hutecs, which had a contract with Inist Biopharma over generics development, also obtained approval.

Eliquis is the second-largest prescription NOAC, following Xarelto. As local drugmakers are keen to develop Eliquis copies, observers pay attention to whether the latest approval will lead to additional nods for other Eliquis-copying drugs.

Despite the approval, drugmakers are likely to delay the launch of their generic drugs because Eliquis’ substance patent remains until Sept. 9, 2024. Also, a new patient in ingredient was registered on Jan. 15 which will continue until Feb. 24, 2031.

Local drugmakers applied for invalidation of the substance patent or cancellation of the extension of the patent duration, but all of them were rejected. Some of the companies voluntarily canceled the suit.

As Pfizer registered the patent in the ingredient apixaban on Jan. 15 in defense, other drugmakers will find it difficult to avoid the patent and release their generic products, observers said.