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Letermovir Tablets

As of 13 November 2026, for Letermovir Tablets, 7 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 5 holders.

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

Listed in the US FDA Orange Book as PREVYMIS (NDA 209939, MERCK SHARP AND DOHME CORP).

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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 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
PREVYMIS MERCK SHARP AND DOHME CORP NDA 209939 · Product no. 001, 002 TABLET ORAL HUMAN PRESCRIPTION DRUG 2017/11/08

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
PREVYMIS MERCK SHARP AND DOHME CORP NDA 209940 · Product no. 001, 002 SOLUTION INTRAVENOUS HUMAN PRESCRIPTION DRUG 2017/11/08
PREVYMIS MERCK SHARP AND DOHME LLC NDA 219104 · Product no. 001, 002 PELLETS ORAL HUMAN PRESCRIPTION DRUG 2024/08/30

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: 5 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 5 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanizedJiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized国药准字H202655472026/08/04240mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Hai Zheng Pharma Co., Ltd. romanizedZhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H202651402026/07/080.24gGeneric approved under the new chemical-drug registration classificationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H202560712025/11/25240mgGeneric approved under the new chemical-drug registration classificationCDE
Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanizedChongqing Bo Teng Pharma Co., Ltd. romanized国药准字H202541892025/05/20240mgGeneric 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H202434492024/04/07240mgGeneric 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: 7 distinct approval numbers and 6 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.国药准字H20243449240mgCategory BXJ05AXL400A001010101606NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H20256071240mgCategory BXJ05AXL400A001010104021NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H202651400.24gCategory BXJ05AXL400A001010104641NHSA
Merck Sharp & Dohme B.V.国药准字HJ20210085240mgCategory BXJ05AXL400A001010179325NHSA
Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254189240mgCategory BXJ05AXL400A001010184682NHSA
Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized国药准字H20265547240mgCategory BXJ05AXL400A001010185211NHSA
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.国药准字H20243449240mgCategory BXJ05AXL400A001010201606NHSA
Zhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H202651400.24gCategory BXJ05AXL400A001010204641NHSA
Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254189240mgCategory BXJ05AXL400A001010284682NHSA
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.国药准字H20243449240mgCategory BXJ05AXL400A001010301606NHSA
Merck Sharp & Dohme B.V.国药准字HJ20210086480mgCategory BXJ05AXL400A001020179325NHSA

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: 7 filings and 7 distinct first applicants.

Generic 7

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Lukang Pharmaceutical Co.,Ltd.CYHS2600847Generic2026/04/13Not stated by sourceCDE
Wang Shan Wang Shui (Lian Yun Gang) Pharmaceutical Co., Ltd. romanizedCYHS2600650Generic2026/03/12Not stated by sourceCDE
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanizedCYHS2602303Generic2026/09/16Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2503589Generic2025/09/30Not stated by sourceCDE
Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS2503046Generic2025/08/19Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2503032Generic2025/08/19Not stated by sourceCDE
Suzhou Di Yi Pharmaceutical Co., Ltd. romanizedCYHS2602787Generic2026/11/12Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Lukang Pharmaceutical Co.,Ltd.CYHS2600847Generic2026/04/13Not stated by sourceCDE
Wang Shan Wang Shui (Lian Yun Gang) Pharmaceutical Co., Ltd. romanizedCYHS2600650Generic2026/03/12Not stated by sourceCDE
Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanizedCYHS2602303Generic2026/09/16Not stated by sourceCDE
Suzhou Di Yi Pharmaceutical Co., Ltd. romanizedCYHS2602787Generic2026/11/12Not stated by sourceCDE
API registrations

Non-component matches: 8 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
来特莫韦 · No verified English nameShandong Te Fa Man Pharma Co., Ltd. romanizedY20250001286IExact ingredient2025/12/12CDE
来特莫韦 · No verified English nameYi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanizedY20250000919IExact ingredient2025/09/02CDE
来特莫韦 · No verified English nameHainan He Rui Pharmaceutical Co., Ltd. romanizedY20250000746IExact ingredient2025/07/31CDE
来特莫韦 · No verified English nameShandong Lukang Pharmaceutical Co.,Ltd.Y20250000637IExact ingredient2025/07/07CDE
来特莫韦 · No verified English nameHebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanizedY20240000795AExact ingredient2026/08/07CDE
来特莫韦 · No verified English nameZhejiang Hai Zheng Pharma Co., Ltd. romanizedY20240001247AExact ingredient2026/06/29CDE
来特莫韦 · No verified English nameJiangsu Zheng Ji Pharma Co., Ltd. romanizedY20240000742AExact ingredient2026/04/23CDE
来特莫韦 · No verified English nameShanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanizedY20240000784AExact ingredient2026/03/20CDE
来特莫韦 · No verified English nameShandong An Hong Pharmaceutical Co., Ltd. romanizedY20240000372AExact ingredient2025/10/27CDE
来特莫韦 · No verified English nameShandong Cheng Hui Shuang Da Pharma Co., Ltd. romanizedY20240000270AExact ingredient2026/07/18CDE
来特莫韦 · No verified English nameLupin Manufacturing Solutions LimitedY20230000163IExact ingredient2024/02/27CDE
来特莫韦 · No verified English nameZhejiang Che Tou Pharmaceutical Co., Ltd. romanizedY20230001068AExact ingredient2026/06/02CDE
来特莫韦 · No verified English nameJing Hua Pharmaceutical Group Nan Tong Co., Ltd. romanizedY20220000826AExact ingredient2024/03/15CDE

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. 2026/11/12Accepted

    Suzhou Di Yi Pharmaceutical Co., Ltd. romanized

    CYHS2602787

    Fact date: 2026/11/12 · Site observation date: 2026/11/13

    View source ↗
  2. 2026/10/31No longer listed under review

    Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

    CYHB2601529

    Fact date: 2026/10/31 · Site observation date: 2026/10/31

    Accepted: 2026/08/11

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/30 (approval no.: —; approval date: 2026/10/29); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 12

    NMPA · Table row 12 ↗ View source ↗
  3. 2026/10/29Supplement delivery

    Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

    CYHB2601529

    Fact date: 2026/10/29 · Publication date: 2026/10/30 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 12 ↗
  4. 2026/10/20Supplement delivery

    Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized

    CYHB2601470

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 8 ↗
  5. 2026/09/16Accepted

    Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized

    CYHS2602303

    Fact date: 2026/09/16 · 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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