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Ibrutinib Capsules

As of 14 November 2026, for Ibrutinib Capsules, 9 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 10 holders.

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

Listed in the US FDA Orange Book as IMBRUVICA (NDA 205552, PHARMACYCLICS LLC).

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Complete CDE snapshot
2026/11/14 06:44
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
IMBRUVICA PHARMACYCLICS LLC NDA 205552 · Product no. 001 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 2013/11/13
IMBRUVICA PHARMACYCLICS LLC NDA 205552 · Product no. 002 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 2017/12/20

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
IMBRUVICA PHARMACYCLICS LLC NDA 210563 · Product no. 001, 002, 003 TABLET ORAL HUMAN PRESCRIPTION DRUG 2018/02/16
IMBRUVICA PHARMACYCLICS LLC NDA 217003 · Product no. 001 SUSPENSION ORAL HUMAN PRESCRIPTION DRUG 2022/08/24
IMBRUVICA PHARMACYCLICS LLC NDA 210563 · Product no. 004 TABLET ORAL DISCONTINUED 2018/02/16

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: 10 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanizedZhejiang Hua Yi Pharmaceutical Co., Ltd. romanized国药准字H202643372026/05/19140mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai Shyndec Pharmaceutical Co., Ltd.Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized国药准字H202643392026/05/19140mgGeneric approved under the new chemical-drug registration classificationCDE
YaoPharma Co., Ltd.YaoPharma Co., Ltd.国药准字H202636932026/03/25140mgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.国药准字H202549862025/07/29140mgGeneric approved under the new chemical-drug registration classificationCDE
Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H202546822025/06/30140mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Ke Rui Pharma Co., Ltd. romanizedJiangxi Ke Rui Pharma Co., Ltd. romanized国药准字H202531132025/01/08140mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Qidu Pharmaceutical Co., Ltd.Beijing Ya Bao Bio Pharma Co., Ltd. romanized国药准字H202495662024/12/01140mgGeneric approved under the new chemical-drug registration classificationCDE
M/s Natco Pharma LimitedM/s Natco Pharma Limited国药准字HJ202401202024/10/29140mgGeneric approved under the new chemical-drug registration classificationCDE
Xian Sheng Pharma Co., Ltd. romanizedXian Sheng Pharma Co., Ltd. romanized国药准字H202237192022/10/11140mgGeneric approved under the new chemical-drug registration classificationCDE
Pharmacyclics LLCCatalent CTS LLCH201703502017/08/24140mgImported 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: 5 distinct approval numbers and 5 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing SL Pharmaceutical Co., Ltd.国药准字H20266103140mgCategory BXL01ELY299E001010100148NHSA
YaoPharma Co., Ltd.国药准字H20263693140mgCategory BXL01ELY299E001010101066NHSA
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.国药准字H20254986140mgCategory BXL01ELY299E001010101606NHSA
Janssen-Cilag International NV国药准字HJ20181066140mgCategory BXL01ELY299E001010182102NHSA
Janssen-Cilag International NV国药准字HJ20181066140mgCategory BXL01ELY299E001010282102NHSA
Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized国药准字H20264337140mgCategory BXL01ELY299E001010104650NHSA

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: 9 filings and 8 distinct first applicants.

Generic 4 · Supplement 4 · Import re-registration 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCYHS2503756Generic2025/10/22Not stated by sourceCDE
Janssen-Cilag International NV; Catalent CTS LLC; Cilag AGJYHB2600561Supplement2026/10/21Not stated by sourceCDE
Jin Hong Pharma Co., Ltd. romanizedCYHS2602368Generic2026/09/21Not stated by sourceCDE
Shanghai Shyndec Pharmaceutical Co., Ltd.; Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanizedCYHB2601777Supplement2026/09/21Not stated by sourceCDE
Shandong Qidu Pharmaceutical Co., Ltd.; Beijing Ya Bao Bio Pharma Co., Ltd. romanizedCYHB2601763Supplement2026/09/20Not stated by sourceCDE
Janssen-Cilag International NV; Catalent CTS LLC; Cilag AG; Xian-Janssen Pharmaceutical Ltd.JYHZ2600188Import re-registration2026/08/05Not stated by sourceCDE
Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized; Beijing Ya Bao Bio Pharma Co., Ltd. romanizedCYHS2601071Generic2026/05/12Not stated by sourceCDE
Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanizedCYHS2503353Generic2025/09/10Not stated by sourceCDE
Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedCYHB2602007Supplement2026/11/05Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jin Hong Pharma Co., Ltd. romanizedCYHS2602368Generic2026/09/21Not stated by sourceCDE
Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized; Beijing Ya Bao Bio Pharma Co., Ltd. romanizedCYHS2601071Generic2026/05/12Not stated by sourceCDE
API registrations

Non-component matches: 14 companies with A status and 10 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
伊布替尼 · No verified English nameZhejiang Ao Xiang Pharma Co., Ltd. romanizedY20260000087IExact ingredient2026/02/10CDE
伊布替尼 · No verified English nameZhejiang Ao Xiang Pharma Co., Ltd. romanizedY20250001309IExact ingredient2025/12/16CDE
伊布替尼 · No verified English nameLian Yun Gang Gui Ke Pharma Co., Ltd. romanizedY20250000804IExact ingredient2025/08/20CDE
伊布替尼 · No verified English nameCdymax(India)Pharma Private LimitedY20250000365IExact ingredient2025/06/05CDE
伊布替尼 · No verified English nameChongqing Rui Po Lai Pharmaceutical Co., Ltd. romanizedY20250000516IExact ingredient2025/05/30CDE
伊布替尼 · No verified English nameSichuan Hong Yuan Pharma Co., Ltd. romanizedY20250000479IExact ingredient2025/05/28CDE
伊布替尼 · No verified English nameShandong Lukang Pharmaceutical Co.,Ltd.Y20250000133IExact ingredient2025/02/08CDE
伊布替尼 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20240001561AExact ingredient2026/06/04CDE
伊布替尼 · No verified English nameZhejiang Jing Sheng Pharma Co., Ltd. romanizedY20240001142AExact ingredient2026/10/29CDE
伊布替尼 · No verified English nameGuangzhou Ke Rui Te Pharma Co., Ltd. romanizedY20240000976IExact ingredient2024/11/27CDE
伊布替尼 · No verified English nameJiangsu Wei Qi Da Pharma Co., Ltd. romanizedY20240001272IExact ingredient2024/11/14CDE
伊布替尼 · No verified English nameXuan Cheng Mei Nuo Hua Pharma Co., Ltd. romanizedY20240001011AExact ingredient2026/06/11CDE
伊布替尼 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20240000915AExact ingredient2026/04/14CDE
伊布替尼 · No verified English nameZhejiang Hua Yi Pharmaceutical Co., Ltd. romanizedY20240000629AExact ingredient2026/09/21CDE
伊布替尼 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20240000254AExact ingredient2025/11/10CDE
伊布替尼 · No verified English nameJin Hong Pharma Co., Ltd. romanizedY20240000272AExact ingredient2026/01/08CDE
伊布替尼 · No verified English nameChongqing Kai Lin Pharmaceutical Co., Ltd. romanizedY20230000989AExact ingredient2026/08/21CDE
伊布替尼 · No verified English nameGuangdong Lai Fu Shi Pharmaceutical Technology Co., Ltd. romanizedY20230001268AExact ingredient2026/09/09CDE
伊布替尼 · No verified English nameDr. Reddy’s Laboratories Ltd.Y20230001057IExact ingredient2024/01/03CDE
伊布替尼 · No verified English nameJiangsu Hui Ju Pharma Co., Ltd. romanizedY20230000804AExact ingredient2025/01/26CDE
伊布替尼 · No verified English nameJiangxi Ke Rui Pharma Co., Ltd. romanizedY20230000444AExact ingredient2025/04/26CDE
伊布替尼 · No verified English nameShandong An Xin Pharmaceutical Co., Ltd. romanizedY20230000290AExact ingredient2025/01/12CDE
伊布替尼 · No verified English nameChongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanizedY20210001234AExact ingredient2026/03/14CDE
伊布替尼 · No verified English nameXian Sheng Pharma Co., Ltd. romanizedY20200001176AExact ingredient2024/01/17CDE

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: 2026/11/14 06:40. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

  1. 2026/11/05Accepted
  2. 2026/11/04No longer listed under review

    Zhejiang Nord Pharmaceutical Co., Ltd

    CYHS2500657

    Fact date: 2026/11/04 · Site observation date: 2026/11/04

    Accepted: 2025/02/09

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

    View source ↗
  3. 2026/11/03Marketing application approved

    Chengdu Kang Hong Pharma Group Co., Ltd. romanized

    CYHS2502292 · 国药准字H20266472

    Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06

    The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.

    View source · Table row 86 ↗
  4. 2026/10/21Accepted

    Janssen-Cilag International NV; Catalent CTS LLC; Cilag AG

    JYHB2600561

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

    View source ↗
  5. 2026/09/21Accepted

    Jin Hong Pharma Co., Ltd. romanized

    CYHS2602368

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

    View source ↗
  6. 2026/09/21Accepted

    Shanghai Shyndec Pharmaceutical Co., Ltd.; Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized

    CYHB2601777

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

    View source ↗
  7. 2026/09/20Accepted

    Shandong Qidu Pharmaceutical Co., Ltd.; Beijing Ya Bao Bio Pharma Co., Ltd. romanized

    CYHB2601763

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/14 06:44
Chemical-drug catalogue
Last successful update: 2026/11/14 06:40

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: 2026/11/14 06:43
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: 2026/11/14 18:32

First index-page publication dates: 2026-10-29 to 2026-11-13; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/14 08:10 · 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: 0. 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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