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Bimatoprost Eye Drops

As of 13 November 2026, for Bimatoprost Eye Drops, 3 applications are listed as under review at China's CDE; 2 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 LUMIGAN (NDA 022184, ABBVIE INC).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

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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 4 of 4 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: Eye Drops. 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
LUMIGAN ABBVIE INC NDA 022184 · Product no. 001 SOLUTION/DROPS OPHTHALMIC HUMAN PRESCRIPTION DRUG 2010/08/31
LUMIGAN ABBVIE INC NDA 021275 · Product no. 001 SOLUTION/DROPS OPHTHALMIC DISCONTINUED 2001/03/16

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
LATISSE ABBVIE INC NDA 022369 · Product no. 001 SOLUTION/DROPS TOPICAL HUMAN PRESCRIPTION DRUG 2008/12/24
DURYSTA ABBVIE INC NDA 211911 · Product no. 001 IMPLANT OPHTHALMIC HUMAN PRESCRIPTION DRUG 2020/03/04
ZOLYMBUS THEA PHARMA INC NDA 217307 · Product no. 001 GEL OPHTHALMIC HUMAN PRESCRIPTION DRUG 2025/09/09

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 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Allergan Inc.Allergan Sales LLCH201504852005/04/205ml:1.5mgImported originator drugCDE
Allergan Inc.Allergan Sales LLCH201504842005/04/203mL:0.9mgImported originator drugCDE

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: 7 distinct approval numbers and 7 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Bei Lu Pharma Co., Ltd. romanized国药准字H202660250.03%(3ml: 0.9mg)Category BXS01EEB032G010010100014NHSA
Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized国药准字H202130690.03%(3ml:0.9mg)Category BXS01EEB032G010010101967NHSA
AbbVie Deutschland GmbH & Co. KG国药准字HJ201504843ml:0.9mgCategory BXS01EEB032G010010178204NHSA
Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized国药准字H202448920.03%(0.4ml:0.12mg)Category BXS01EEB032G010010181835NHSA
Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized国药准字H202441030.03%(3ml:0.9mg)Category BXS01EEB032G010010183124NHSA
Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized国药准字H202644720.03%(3ml:0.9mg)Category BXS01EEB032G010010183867NHSA
Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized国药准字H202448920.03%(0.4ml:0.12mg)Category BXS01EEB032G010010281835NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H202658820.03%(0.4ml:0.12mg)Category BXS01EEB032G010010105816NHSA
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H202658820.03%(0.4ml:0.12mg)Category BXS01EEB032G010010205816NHSA

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: 3 filings and 2 distinct first applicants.

Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2602555Generic2026/10/16Not stated by sourceCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2602554Generic2026/10/16Not stated by sourceCDE
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanizedCYHS2600967Generic2026/04/27Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2602555Generic2026/10/16Not stated by sourceCDE
Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTDCYHS2602554Generic2026/10/16Not stated by sourceCDE
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanizedCYHS2600967Generic2026/04/27Not stated by sourceCDE
API registrations

Non-component matches: 6 companies with A status and 5 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
贝美前列素 · No verified English nameZhejiang Ao Xiang Pharma Co., Ltd. romanizedY20250001251IExact ingredient2025/11/19CDE
贝美前列素 · No verified English nameQing Yuan Mei Ruo Ke Pharmaceutical Co., Ltd. romanizedY20250001077IExact ingredient2025/10/15CDE
贝美前列素 · No verified English nameZhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanizedY20250000394AExact ingredient2026/10/14CDE
贝美前列素 · No verified English nameTaiwan Yong Guang Chemical Gong Ye Co., Ltd. Di Er Factory romanizedY20220000819AExact ingredient2025/01/26CDE
贝美前列素 · No verified English nameYS Life Science Co., Ltd.Y20210000911AExact ingredient2024/06/05CDE
贝美前列素 · No verified English nameShen Long Pharmaceuticals (Chang Shu) Co., Ltd. romanizedY20190000495AExact ingredient2026/03/10CDE
贝美前列素 · No verified English nameEUROAPI Hungary Ltd.Y20190000442AExact ingredient2026/10/30CDE
贝美前列素 · No verified English nameShanghai Tian Wei Biopharmaceutical Co., Ltd. romanizedY20170000690IExact ingredient—CDE
贝美前列素 · No verified English nameWuhan Wu Yao Pharmaceutical Co., Ltd. romanizedY20170000245AExact ingredient2023/07/04CDE
贝美前列素 · No verified English nameJiangsu Sheng Di Pharmaceuticals Co., Ltd. romanizedY20170000240IExact ingredient—CDE
贝美前列素 · No verified English nameTianjin Xin Hui Pharmaceutical Co., Ltd. romanizedY20170000155IExact ingredient—CDE

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. 2026/10/16Accepted

    Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD

    CYHS2602555

    Fact date: 2026/10/16 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/10/16Accepted

    Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD

    CYHS2602554

    Fact date: 2026/10/16 · Site observation date: 2026/10/22

    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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