Shuangcheng Pharmaceutical successfully challenged the patent of bivalirudin for injection

Hainan Shuangcheng Pharmaceutical Co., Ltd..A PIV statement was submitted to the U.S. FDA on May 2, 2019, and a notice of patent challenge was sent by courier to the original research drug bivalirudin for injection and the patent holder, and the receipt confirmation notice was obtained on May 3, 2019. The original research drug of bivalirudin for injection (Angiomax) was developed by Biogen Company of Switzerland and transferred to Medicines Company of the United States. It was first listed in New Zealand in October 1999 and then approved by FDA in the United States on December 15, 2000.

As required by U.S. regulations, upon receipt of notice.45 days is the prescribed time limit for the listing license holder and patent holder to file a patent infringement lawsuit. If the listing license holder and patent holder give up filing a patent infringement lawsuit within 45 days after receiving the notice of patent challenge, the simplified new drug application (ANDA) for generic bivalirudin injection can successfully apply to FDA for final listing approval. The original research company did not initiate any litigation to challenge the patent of bivalirudin for injection of Shuangcheng Pharmaceutical within 45 days after receiving the notice. In view of this, Shuangcheng Pharmaceutical has notified the FDA of the above progress and has submitted an application for final approval of bivalirudin generic for injection.

Bivalirudin

Bivalirudin is a synthetic anticoagulant drug, which can specifically bind to the thrombin catalytic site and anion binding site, and directly inhibit the activity of thrombin, thereby inhibiting the reaction catalyzed and induced by thrombin. The biggest advantage of bivalirudin is that it significantly reduces bleeding events, has a short half-life and its effect is reversible.The peptide bond between Arg3-Pro4 can restore the original biological activity of thrombin. It is mainly used as an anticoagulant for elective percutaneous coronary intervention (PCI) and percutaneous transluminal coronary angioplasty (PTCA) in adults, and for patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombotic syndrome (HITTS) in PCI. According to the announcement, sales of bivalirudin for injection in the US market in 2018 were US $81.8 million.

Chinese name: Bivalirudin

English Name:Bivalirudin

Molecular formula:C₉₈H₁₃₈N₂₄O₃₃

United StatesPIVpatent challenge system

AccordingThe Hatch-Waxman Act provides that generic drug manufacturers must submit one of the following four statements when submitting an ANDA in accordance with the provisions of the Orange Book:

SectionParagraph I statement (PI): The drug is unpatented;

SectionParagraph II statement (PII): The drug has a patent, but the patent has expired;

SectionParagraph III Statement (PIII): FDA is not required to approve the generic drug before the relevant patent expires;

SectionParagraph IV statement (PIV): The patent relating to the generic drug being applied for is invalid (Strategy 1) or the generic drug is not infringing (Strategy 2).

Among them,The ANDA declared by PIV is a typical generic drug challenge patent, and the PIV statement is a challenge. Products containing PIV patent challenges can be submitted to ANDA on the NCE-1 day (I .e. the first day 48 months after the NDA approval date), which is usually called the "first imitation day". If several generic drug companies submit ANDA on this day, they will jointly have a 180-day market monopoly period after the patent challenge is successful. Within 20 working days after its ANDA is accepted, the applicant with PIV declaration shall notify the NDA holder and the patentee in time, and provide the legal basis for the non-infringement of generic drug products or the invalidation of the patent of the original research enterprise. If the NDA holder and/or the patentee file a patent infringement lawsuit within 45 days, the 30-month containment period will start, and within this 30-month period, FDA will continue to review the materials of ANDA applicants, and if the materials are qualified, they will be granted provisional approval, but they will not be approved for marketing. If the lawsuit decides that the patent is invalid or the product is not infringing during the containment period, the provisional approval is converted into a formal approval on the effective date of the judgment, allowing listing and obtaining a 180-day market exclusivity period.

Summary

Shuangcheng Pharmaceuticals said that the patent challenge launched in the United States directly reflects the company's comprehensive ability in the research and development, registration and handling of patent affairs of generic drugs. The success of this patent challenge will enable the company to develop bivalirudin, a generic drug product for injection, in the original research patent (valid2029Year1Month27day) before the expiration of the market in the United States, for the follow-up in the United States to carry out generic drug registration and sales laid an important foundation.

The internationalization process of Chinese pharmaceutical companies has accelerated significantly in recent years, and they have launched an impact on more difficult generic drug varieties step by step. It is foreseeable that in the future, more domestic pharmaceutical companies will definitely launch high-tech drug research companiesPIVThe patent challenge.