Home Innovations The most competitive generic drug of the year has been approved again

The most competitive generic drug of the year has been approved again

Sep 08, 2025 17:21 CST Updated Sep 09, 15:05


On September 5, the NMPA issued an approval document, adding another qualified company for injectable acetylcysteine. This is the second successful approval following Sichuan Huiyu's approval in October 2024.
At this point, the competitive landscape for this breed has become even more crowded.
Why is it considered the most competitive generic drug this year? Just four months after the original drug's market launch, 50 companies have already submitted applications for market entry—a number and speed that are almost unprecedented in recent years among generic drugs.
The timeline is very tight. On October 16, 2024, Sichuan Huiyu Pharmaceutical'sAcetylcysteine InjectionTo 3Generic version approved,Specification 30ml: 6g, used for the detoxification of acute acetaminophen poisoning, and for the prevention or mitigation of its effects.Liver injury caused by overdose, as the first domestically approved company.
But the indications for which Huiyu has gained approval are not the mainstream indications with a large market. As is well known, the real market for acetylcysteine lies in expectorant use.
Symptoms of Respiratory System Diseases: Excessive Mucus SecretionCommon expectorant components in treatments include: bromhexine, ambroxol, and acetylcysteine. The first two are only available as injections.The total market value before the centralized procurement was close to 10 billion yuan, and then it was included in the national centralized procurement consecutively in 2021 and 2022, resulting in a sharp decline in sales.
Acetylcysteine Injection is the most powerful alternative to the first two. The same component variety, Acetylcysteine Solution for Inhalation, has quickly taken the top position among inhaled expectorants within just a few years, demonstrating the excellence of the acetylcysteine component.
Source: Mosen Pharmaceuticals
For such a vast market, many companies have previously attempted to replicate the product. However, due to the reference specifications and indications not being marketed domestically, applications have been repeatedly rejected, with this particular variety having been turned down for replication 21 times already in China.
Until this yearMay,Original Research ZambonAcetylcysteine InjectionApproved domestically,Specification 3ml:0.3g, for use inTreatment of respiratory diseases with excessive thick mucus secretion.
The original research product was launched, and the door for generics was fully opened. In just over four months, there have been 50 domestic generic market entry applications, an astonishing number. The Acetylcysteine Injection is also the product with the most companies submitting marketing applications in 2025.
Looking back at Sichuan Haimeng's recent approval, Huiyu was approved for the detoxification indication. So, what about Haimeng?
Sichuan Haimeng is a consistency evaluation conducted through a supplementary application, with the acceptance numberCYHB2450358, the previously held approval number by Sichuan Haimeng was National Medicine Approval No. H20183104,Specification:20ml:4g；The indication corresponding to this document number is: Used in the early treatment of liver failure on the basis of comprehensive treatment to reduce bilirubin and increase prothrombin activity.
If this supplementary application passes consistency without changing the indications, the indications should be related to liver protection.
However, it should be noted that Sichuan Haimeng has been granted a new approval number this time: National Medicine Approval Number H20258179. The supplementary application method for evaluation should not change the approval number. Therefore, this newly approved number is highly likely to be for a newly approved specification. The addition of a new specification can proceed simultaneously with the supplementary application for consistency evaluation:
In other words, Sichuan Haimeng may have added a new specification that has passed the evaluation, and that specification is very likely to be3ml:0.3g, Indications are related to the respiratory system.
If the approved indication for Sichuan Haimeng is confirmed to be expectorant, then acetylcysteineThe competition in the field of respiratory system for injections will officially begin. From the original research to market launch, and then to the approval of generic versions, the window period is as short as only 4 months, setting a record for the shortest window period. Afterwards, the remaining more than 50 companies...If there are no pharmaceutical issues, it should also be possible.Can pass smoothly.
If it is still related to detoxification and liver protection, then Zambon still has a window period of about one year. However, in any case, the original research of Zambon...After more than three years, completing Phase III clinical trials and being launched domestically seems to have paved the way for domestic generic drug companies.。
Attachment: Directory of companies that have submitted marketing applications for Acetylcysteine Injection, with blue marking indicating two records.