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Brivaracetam Tablets

As of 13 November 2026, for Brivaracetam Tablets, 19 applications are listed as under review at China's CDE; 7 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as BRIVIACT (NDA 205836, UCB INC).

Follow for free
Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 1 of 1 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
BRIVIACT UCB INC NDA 205836 · Product no. 001, 002, 003, 004, 005 TABLET ORAL HUMAN PRESCRIPTION DRUG 2016/05/12

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
BRIVIACT UCB INC NDA 205837 · Product no. 001 SOLUTION INTRAVENOUS HUMAN PRESCRIPTION DRUG 2016/05/12
BRIVIACT UCB INC NDA 205838 · Product no. 001 SOLUTION ORAL HUMAN PRESCRIPTION DRUG 2016/05/12

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

Chemical-drug catalogue

Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Jiangxi Qing Feng Pharma Co., Ltd. romanizedJiangxi Qing Feng Pharma Co., Ltd. romanized国药准字H202442722024/06/2850mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Qing Feng Pharma Co., Ltd. romanizedJiangxi Qing Feng Pharma Co., Ltd. romanized国药准字H202442712024/06/2825mgGeneric approved under the new chemical-drug registration classificationCDE

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

NHSA drug codes

Loaded records: 2 distinct approval numbers and 1 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jiangxi Ke Rui Pharma Co., Ltd. romanized国药准字H2024427250mgCategory BXN03AXB264A001010105337NHSA
Jiangxi Ke Rui Pharma Co., Ltd. romanized国药准字H2024427125mgCategory BXN03AXB264A001020105337NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 19 filings and 8 distinct first applicants.

Generic 17 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhejiang Nord Pharmaceutical Co., LtdCYHS2602090Generic2026/08/21Not stated by sourceCDE
Zhejiang Nord Pharmaceutical Co., LtdCYHS2602089Generic2026/08/21Not stated by sourceCDE
Zhejiang Nord Pharmaceutical Co., LtdCYHS2602088Generic2026/08/21Not stated by sourceCDE
Xi Nan Pharma Co., Ltd. romanizedCYHS2602507Generic2026/10/13Not stated by sourceCDE
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanizedCYHS2602456Generic2026/10/09Not stated by sourceCDE
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanizedCYHS2602455Generic2026/10/09Not stated by sourceCDE
Jiangxi Ke Rui Pharma Co., Ltd. romanizedCYHB2601498Supplement2026/08/04Not stated by sourceCDE
Jiangxi Ke Rui Pharma Co., Ltd. romanizedCYHB2601497Supplement2026/08/04Not stated by sourceCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS2601699Generic2026/07/16Not stated by sourceCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS2601698Generic2026/07/16Not stated by sourceCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS2601697Generic2026/07/16Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600068Generic2026/01/08Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600067Generic2026/01/08Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600065Generic2026/01/08Not stated by sourceCDE
Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.CYHS2501808Generic2025/05/17Not stated by sourceCDE
Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.CYHS2501807Generic2025/05/17Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2602745Generic2026/11/09Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2602744Generic2026/11/09Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2602743Generic2026/11/09Not stated by sourceCDE
New generic filings in 2026

Loaded records: 18 filings and 7 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhejiang Nord Pharmaceutical Co., LtdCYHS2602090Generic2026/08/21Not stated by sourceCDE
Zhejiang Nord Pharmaceutical Co., LtdCYHS2602089Generic2026/08/21Not stated by sourceCDE
Zhejiang Nord Pharmaceutical Co., LtdCYHS2602088Generic2026/08/21Not stated by sourceCDE
Xi Nan Pharma Co., Ltd. romanizedCYHS2602507Generic2026/10/13Not stated by sourceCDE
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanizedCYHS2602456Generic2026/10/09Not stated by sourceCDE
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanizedCYHS2602455Generic2026/10/09Not stated by sourceCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS2601699Generic2026/07/16Not stated by sourceCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS2601698Generic2026/07/16Not stated by sourceCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.CYHS2601697Generic2026/07/16Not stated by sourceCDE
Chengdu Ao Bang Pharma Co., Ltd. romanizedCYHS2600146Generic2026/01/13Not stated by sourceCDE
Chengdu Ao Bang Pharma Co., Ltd. romanizedCYHS2600145Generic2026/01/13Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600068Generic2026/01/08Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600067Generic2026/01/08Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600066Generic2026/01/08Not stated by sourceCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.CYHS2600065Generic2026/01/08Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2602745Generic2026/11/09Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2602744Generic2026/11/09Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2602743Generic2026/11/09Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 24 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
布立西坦 · No verified English nameYi Chang Tian Ren Pharma Co., Ltd. romanizedY20260000858IExact ingredient2026/10/12CDE
布立西坦 · No verified English nameChengdu Ao Bang Pharma Co., Ltd. romanizedY20260000747IExact ingredient2026/09/09CDE
布立西坦 · No verified English nameZhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanizedY20250001382IExact ingredient2026/01/05CDE
布立西坦 · No verified English nameSichuan Hui Yu Pharmaceutical Co., Ltd. romanizedY20250001175IExact ingredient2025/11/13CDE
布立西坦 · No verified English nameHebei Yi Pin Pharmaceutical Co., Ltd. romanizedY20250000528IExact ingredient2025/06/13CDE
布立西坦 · No verified English nameYang Zhou Ao Rui Te Pharma Co., Ltd. romanizedY20250000343IExact ingredient2025/05/20CDE
布立西坦 · No verified English nameZhejiang Dong Ya Pharma Co., Ltd. romanizedY20250000038AExact ingredient2026/10/10CDE
布立西坦 · No verified English nameShanghai Zhong Xi San Wei Pharma Co., Ltd. romanizedY20240001549IExact ingredient2025/02/26CDE
布立西坦 · No verified English nameZhi En Bio Technology Co., Ltd. romanizedY20240001550IExact ingredient2025/01/13CDE
布立西坦 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20240001376AExact ingredient2026/06/24CDE
布立西坦 · No verified English nameZhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanizedY20240000959AExact ingredient2026/06/04CDE
布立西坦 · No verified English nameZhejiang Tian Yu Pharma Co., Ltd. romanizedY20240000776AExact ingredient2026/06/01CDE
布立西坦 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20240000811IExact ingredient2025/11/10CDE
布立西坦 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20240000752IExact ingredient2025/10/27CDE
布立西坦 · No verified English nameShanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanizedY20240000746AExact ingredient2026/05/07CDE
布立西坦 · No verified English nameGui Lin Nan Yao Co., Ltd. romanizedY20240000394IExact ingredient2025/10/27CDE
布立西坦 · No verified English nameHubei Bao Le Biopharmaceuticals Technology Co., Ltd. romanizedY20230000993IExact ingredient2023/11/24CDE
布立西坦 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20230000692IExact ingredient2023/08/22CDE
布立西坦 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20230000549AExact ingredient2025/12/29CDE
布立西坦 · No verified English nameChengdu Bai Yu Pharmaceutical Co., Ltd. romanizedY20210000848IExact ingredient2023/06/13CDE
布立西坦 · No verified English nameJi Chuan Pharma Group Co., Ltd. romanizedY20230000249IExact ingredient2023/04/06CDE
布立西坦 · No verified English nameChengdu Ao Bang Pharma Co., Ltd. romanizedY20230000092IExact ingredient2023/03/22CDE
布立西坦 · No verified English nameFujian Nan Fang Pharmaceutical Co., Ltd. romanizedY20220001065IExact ingredient2023/01/30CDE
布立西坦 · No verified English nameJiangxi Ke Rui Pharma Co., Ltd. romanizedY20220001288AExact ingredient2024/12/27CDE
布立西坦 · No verified English nameZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.Y20220001275AExact ingredient2026/03/31CDE
布立西坦 · No verified English nameZhejiang Le Pu Pharma Co., Ltd. romanizedY20220000078IExact ingredient2022/08/24CDE
布立西坦 · No verified English nameChongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanizedY20220000198IExact ingredient2022/07/20CDE
布立西坦 · No verified English nameYang Zhou Ao Rui Te Pharma Co., Ltd. romanizedY20220000479IExact ingredient2022/07/14CDE
布立西坦 · No verified English nameRu Yuan Dong Yang Guang Pharma Co., Ltd. romanizedY20210000784IExact ingredient2021/11/03CDE
布立西坦 · No verified English nameShao Xing Jing Xin Pharma Co., Ltd. romanizedY20210000729IExact ingredient2021/09/01CDE
布立西坦 · No verified English nameHonour Lab Limited, Unit-IIIY20200001316IExact ingredient2021/04/09CDE
布立西坦 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20200001212IExact ingredient2021/02/23CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/11/09Accepted

    Yi Chang Ren Fu Pharma Co., Ltd. romanized

    CYHS2602745

    Fact date: 2026/11/09 · Site observation date: 2026/11/10

    View source ↗
  2. 2026/11/09Accepted

    Yi Chang Ren Fu Pharma Co., Ltd. romanized

    CYHS2602744

    Fact date: 2026/11/09 · Site observation date: 2026/11/10

    View source ↗
  3. 2026/11/09Accepted

    Yi Chang Ren Fu Pharma Co., Ltd. romanized

    CYHS2602743

    Fact date: 2026/11/09 · Site observation date: 2026/11/11

    View source ↗
  4. 2026/10/28Notification delivery

    Chengdu Ao Bang Pharma Co., Ltd. romanized

    CYHS2600146

    Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 19 ↗
  5. 2026/10/28Notification delivery

    Chengdu Ao Bang Pharma Co., Ltd. romanized

    CYHS2600145

    Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 18 ↗
  6. 2026/10/27No longer listed under review

    ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.

    CYHS2600066

    Fact date: 2026/10/27 · Site observation date: 2026/10/27

    Accepted: 2026/01/08

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  7. 2026/10/13Accepted

    Xi Nan Pharma Co., Ltd. romanized

    CYHS2602507

    Fact date: 2026/10/13 · Site observation date: 2026/10/22

    View source ↗
  8. 2026/10/09Accepted

    Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized

    CYHS2602456

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗
  9. 2026/10/09Accepted

    Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized

    CYHS2602455

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗
  10. 2026/08/21Accepted

    Zhejiang Nord Pharmaceutical Co., Ltd

    CYHS2602090

    Fact date: 2026/08/21 · Site observation date: 2026/10/21

    View source ↗
  11. 2026/08/21Accepted

    Zhejiang Nord Pharmaceutical Co., Ltd

    CYHS2602089

    Fact date: 2026/08/21 · Site observation date: 2026/10/21

    View source ↗
  12. 2026/08/21Accepted

    Zhejiang Nord Pharmaceutical Co., Ltd

    CYHS2602088

    Fact date: 2026/08/21 · Site observation date: 2026/10/21

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.

NMPA drug delivery notices
Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete

First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.

Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.

Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

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