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Sign in to subscribeLetermovir Tablets
Matched- Active ingredients (original)
- LETERMOVIR
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval2017/11/08
ANDA applications0
RLD applicantMERCK SHARP AND DOHME CORP
Currently marketed products: 2 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| N209939-001 | PREVYMIS | MERCK SHARP AND DOHME CORP | TABLET | ORAL | LETERMOVIR: 240MG | 2017/11/08 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N209939-002 | PREVYMIS | MERCK SHARP AND DOHME CORP | TABLET | ORAL | LETERMOVIR: 480MG | 2017/11/08 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration2029/01/18
Substance patent expiration (DS flag)2029/01/18
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| N209939-001 | RE46791 | 2029/01/18 | Y / Y | — | — | openFDA ↗ |
| N209939-002 | RE46791 | 2029/01/18 | Y / Y | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2031/08/30
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N209939-001 | D-189 | 2026/08/02 | openFDA ↗ |
| N209939-001 | I-916 | 2026/06/05 | openFDA ↗ |
| N209939-001 | NPP | 2027/08/30 | openFDA ↗ |
| N209939-001 | ODE-423 | 2030/06/05 | openFDA ↗ |
| N209939-001 | ODE-495 | 2031/08/30 | openFDA ↗ |
| N209939-001 | ODE-497 | 2031/08/30 | openFDA ↗ |
| N209939-002 | D-189 | 2026/08/02 | openFDA ↗ |
| N209939-002 | I-916 | 2026/06/05 | openFDA ↗ |
| N209939-002 | NPP | 2027/08/30 | openFDA ↗ |
| N209939-002 | ODE-423 | 2030/06/05 | openFDA ↗ |
| N209939-002 | ODE-495 | 2031/08/30 | openFDA ↗ |
| N209939-002 | ODE-497 | 2031/08/30 | openFDA ↗ |
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. 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.
Catalog holders 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20265547240mg | 2026/08/04 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H202651400.24g | 2026/07/08 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20256071240mg | 2025/11/25 | Official source ↗ |
| Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254189240mg | 2025/05/20 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20243449240mg | 2024/04/07 | Official source ↗ |
NHSA approval numbers 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20243449240mg | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20256071240mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H202651400.24g | — | Official source ↗ |
| Merck Sharp & Dohme B.V. | 国药准字HJ20210085240mg | — | Official source ↗ |
| Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254189240mg | — | Official source ↗ |
| Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20265547240mg | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20243449240mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H202651400.24g | — | Official source ↗ |
| Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254189240mg | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20243449240mg | — | Official source ↗ |
| Merck Sharp & Dohme B.V. | 国药准字HJ20210086480mg | — | Official source ↗ |
Under review 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2600847 | 2026/04/13 | Official source ↗ |
| Wang Shan Wang Shui (Lian Yun Gang) Pharmaceutical Co., Ltd. romanized | CYHS2600650 | 2026/03/12 | Official source ↗ |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | CYHS2602303 | 2026/09/16 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2503589 | 2025/09/30 | Official source ↗ |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | CYHS2503046 | 2025/08/19 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2503032 | 2025/08/19 | Official source ↗ |
| Suzhou Di Yi Pharmaceutical Co., Ltd. romanized | CYHS2602787 | 2026/11/12 | Official source ↗ |
Generic-filing companies this year 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2600847 | 2026/04/13 | Official source ↗ |
| Wang Shan Wang Shui (Lian Yun Gang) Pharmaceutical Co., Ltd. romanized | CYHS2600650 | 2026/03/12 | Official source ↗ |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | CYHS2602303 | 2026/09/16 | Official source ↗ |
| Suzhou Di Yi Pharmaceutical Co., Ltd. romanized | CYHS2602787 | 2026/11/12 | Official source ↗ |
API companies with A status 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized | Y20240000795 | 2026/08/07 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20240001247 | 2026/06/29 | Official source ↗ |
| Jiangsu Zheng Ji Pharma Co., Ltd. romanized | Y20240000742 | 2026/04/23 | Official source ↗ |
| Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20240000784 | 2026/03/20 | Official source ↗ |
| Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20240000372 | 2025/10/27 | Official source ↗ |
| Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20240000270 | 2026/07/18 | Official source ↗ |
| Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized | Y20230001068 | 2026/06/02 | Official source ↗ |
| Jing Hua Pharmaceutical Group Nan Tong Co., Ltd. romanized | Y20220000826 | 2024/03/15 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 41-25 · 2021/05/18
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