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Linaclotide Capsules

As of 13 November 2026, for Linaclotide Capsules, 13 applications are listed as under review at China's CDE; 6 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.

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

Listed in the US FDA Orange Book as LINZESS (NDA 202811, ABBVIE INC).

Last 90 days: Accepted: 5 applicationsApproval-document delivery record: 1 application

Current coverage may be incomplete

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: Capsules. 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
LINZESS ABBVIE INC NDA 202811 · Product no. 001, 002 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 2012/08/30
LINZESS ABBVIE INC NDA 202811 · Product no. 003 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 2017/01/25

Other dosage forms of the same ingredient

No listings in this group among the displayed brand names.

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: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Jiangxi Ke Rui Pharma Co., Ltd. romanizedJiangxi Ke Rui Pharma Co., Ltd. romanized国药准字H202661252026/09/29290μgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanizedChengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanized国药准字H202657742026/09/02290μgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Gowell Pharmaceutical Co., Ltd.Sichuan Gowell Pharmaceutical Co., Ltd.国药准字H202648312026/06/17290μgGeneric approved under the new chemical-drug registration classificationCDE
Hubei Min Kang Pharma Group Co., Ltd. romanizedNanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H202653562026/07/28290μgGeneric 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: 3 distinct approval numbers and 2 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Almac Pharma Services Limited国药准字J20200012290μgCategory BXA06AXL374E001010101359NHSA
AstraZeneca AG国药准字HJ20190001290μgCategory BXA06AXL374E001010178450NHSA
Almac Pharma Services LimitedH20190002290μgCategory BXA06AXL374E001010182573NHSA
AstraZeneca AG国药准字HJ20190001290μgCategory BXA06AXL374E001010278450NHSA
Almac Pharma Services LimitedH20190002290μgCategory BXA06AXL374E001010282573NHSA

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: 13 filings and 13 distinct first applicants.

Generic 13

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Qilu Pharmaceutical (Hainan) Co., LtdCYHS2300919Generic2023/03/28Not stated by sourceCDE
Suzhou Erye Pharmaceutical Co., LtdCYHS2502007Generic2025/06/06Not stated by sourceCDE
Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanizedCYHS2601201Generic2026/05/27Not stated by sourceCDE
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanizedCYHS2502478Generic2025/07/11Not stated by sourceCDE
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized; Jiangsu Fei Ma Pharma Co., Ltd. romanizedCYHS2302540Generic2023/09/20Not stated by sourceCDE
Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized; Name not romanizedCYHS2602110Generic2026/08/25Not stated by sourceCDE
Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanizedCYHS2602062Generic2026/08/20Not stated by sourceCDE
Zhejiang Hang Kang Pharma Co., Ltd. romanizedCYHS2600113Generic2026/01/09Not stated by sourceCDE
Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Name not romanizedCYHS2503547Generic2025/09/28Not stated by sourceCDE
Hunan Ming Rui Pharmaceutical Co., Ltd. romanizedCYHS2503362Generic2025/09/10Not stated by sourceCDE
Shuang He Pharma (Hainan) Co., Ltd. romanizedCYHS2403334Generic2024/10/09Not stated by sourceCDE
You Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanizedCYHS2602627Generic2026/10/26Not stated by sourceCDE
Hainan Tong Yong San Yang Pharma Co., Ltd. romanizedCYHS2602670Generic2026/11/02Not stated by sourceCDE
New generic filings in 2026

Loaded records: 6 filings and 6 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanizedCYHS2601201Generic2026/05/27Not stated by sourceCDE
Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized; Name not romanizedCYHS2602110Generic2026/08/25Not stated by sourceCDE
Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanizedCYHS2602062Generic2026/08/20Not stated by sourceCDE
Zhejiang Hang Kang Pharma Co., Ltd. romanizedCYHS2600113Generic2026/01/09Not stated by sourceCDE
You Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanizedCYHS2602627Generic2026/10/26Not stated by sourceCDE
Hainan Tong Yong San Yang Pharma Co., Ltd. romanizedCYHS2602670Generic2026/11/02Not stated by sourceCDE
API registrations

Non-component matches: 5 companies with A status and 9 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
利那洛肽 · No verified English nameName not romanizedY20260000548IExact ingredient2026/07/23CDE
利那洛肽 · No verified English nameZhejiang Shang Tai Biopharmaceutical Co., Ltd. romanizedY20250001331IExact ingredient2025/12/11CDE
利那洛肽 · No verified English nameHainan Shuang Cheng Pharma Co., Ltd. romanizedY20250001041IExact ingredient2025/10/16CDE
利那洛肽 · No verified English nameHunan Ming Rui Pharmaceutical Co., Ltd. romanizedY20250000681IExact ingredient2025/08/18CDE
利那洛肽 · No verified English nameSichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanizedY20250000775IExact ingredient2025/08/07CDE
利那洛肽 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20250000449IExact ingredient2025/05/13CDE
利那洛肽 · No verified English nameLu Nan Xin Shi Dai Bio Technology Co., Ltd. romanizedY20250000173IExact ingredient2025/03/12CDE
利那洛肽 · No verified English nameSichuan Gowell Pharmaceutical Co., Ltd.Y20240000603AExact ingredient2026/04/29CDE
利那洛肽 · No verified English nameChengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanizedY20240000089AExact ingredient2026/03/02CDE
利那洛肽 · No verified English nameSuzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedY20230000696AExact ingredient2025/09/09CDE
利那洛肽 · No verified English nameHan Yu Pharma (Wuhan) Co., Ltd. romanizedY20220000680AExact ingredient2026/06/21CDE
利那洛肽 · No verified English nameZhong Tai Sheng Hua Co., Ltd. romanizedY20210000906AExact ingredient2025/08/01CDE
利那洛肽 · No verified English nameChengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanizedY20200001056IExact ingredient2020/11/06CDE
利那洛肽 · No verified English namePolyPeptide Laboratories (Sweden) ABY20190021407IExact ingredient2020/05/21CDE

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. 2026/11/02Accepted

    Hainan Tong Yong San Yang Pharma Co., Ltd. romanized

    CYHS2602670

    Fact date: 2026/11/02 · Site observation date: 2026/11/03

    View source ↗
  2. 2026/10/26Accepted
  3. 2026/10/16Approval-document delivery record

    Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized

    JTH2600198

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    View source · Table row 30 ↗
  4. 2026/09/21Accepted

    Almac Pharma Services Limited; AstraZeneca AG; Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized

    JTH2600198

    Fact date: 2026/09/21 · Site observation date: 2026/10/22

    View source ↗
  5. 2026/08/25Accepted

    Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized; Name not romanized

    CYHS2602110

    Fact date: 2026/08/25 · Site observation date: 2026/10/22

    View source ↗
  6. 2026/08/20Accepted

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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