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Sign in to subscribeFluvastatin Sodium Extended Release Tablets
Matched- Active ingredients (original)
- FLUVASTATIN SODIUM
- Dosage form (original)
- TABLET, EXTENDED RELEASE
- 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 approval2000/10/06
ANDA applications3
RLD applicantSANDOZ INC
Currently marketed products: 3 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A079011-001 | FLUVASTATIN SODIUM | TEVA PHARMACEUTICALS USA | TABLET, EXTENDED RELEASE | ORAL | FLUVASTATIN SODIUM: EQ 80MG BASE | 2016/01/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202458-001 | FLUVASTATIN SODIUM | PHARMOBEDIENT CONSULTING LLC | TABLET, EXTENDED RELEASE | ORAL | FLUVASTATIN SODIUM: EQ 80MG BASE | 2015/09/11 | N / N | DISCONTINUED | openFDA ↗ |
| A209397-001 | FLUVASTATIN SODIUM | BEIJING SCIECURE PHARMACEUTICAL CO LTD | TABLET, EXTENDED RELEASE | ORAL | FLUVASTATIN SODIUM: EQ 80MG BASE | 2021/04/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021192-001 | LESCOL XL | SANDOZ INC | TABLET, EXTENDED RELEASE | ORAL | FLUVASTATIN SODIUM: EQ 80MG BASE | 2000/10/06 | 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 expiration—
Substance patent expiration (DS flag)—
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 |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
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 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20265424See source | 2026/07/28 | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | 2026/06/30 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264495See source | 2026/05/27 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264130See source | 2026/04/21 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20263882See source | 2026/04/07 | Official source ↗ |
| Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263287See source | 2026/01/27 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20255562See source | 2025/09/23 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | 2023/12/13 | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213801See source | 2021/10/26 | Official source ↗ |
| Beijing Nuo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H2009017980mg | 2009/04/09 | Official source ↗ |
NHSA approval numbers 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Nuo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H2009017980mg | — | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213801See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264495See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264130See source | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20263882See source | — | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20255562See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | — | Official source ↗ |
| Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263287See source | — | Official source ↗ |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized | 国药准字H20266011See source | — | Official source ↗ |
| Beijing Nuo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H2009017980mg | — | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213801See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264495See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264130See source | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20263882See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | — | Official source ↗ |
| Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263287See source | — | Official source ↗ |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized | 国药准字H20266011See source | — | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20213801See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264495See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264130See source | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20263882See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | — | Official source ↗ |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized | 国药准字H20266011See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264130See source | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H20263882See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20234643See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265054See source | — | Official source ↗ |
| Beijing Nuo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H2009017980mg | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2601303 | 2026/06/04 | Official source ↗ |
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | CYHS2601902 | 2026/08/05 | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2601861 | 2026/08/03 | Official source ↗ |
| Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized | CYHS2600535 | 2026/02/26 | Official source ↗ |
| Guangdong An Nuo Pharma Co., Ltd. romanized | CYHS2600069 | 2026/01/08 | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | CYHS2503534 | 2025/09/28 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2601303 | 2026/06/04 | Official source ↗ |
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | CYHS2601902 | 2026/08/05 | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2601861 | 2026/08/03 | Official source ↗ |
| Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized | CYHS2600535 | 2026/02/26 | Official source ↗ |
| Guangdong An Nuo Pharma Co., Ltd. romanized | CYHS2600069 | 2026/01/08 | Official source ↗ |
API companies with A status 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Xin Li Tai Pharma Co., Ltd. romanized | Y20250000881 | 2026/10/29 | Official source ↗ |
| Zhejiang Ao Xiang Pharma Co., Ltd. romanized | Y20240001245 | 2026/06/01 | Official source ↗ |
| Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20230001392 | 2026/05/18 | Official source ↗ |
| Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized | Y20230000029 | 2024/05/31 | Official source ↗ |
| Biocon Limited | Y20220000062 | 2025/06/07 | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Y20190009733 | 2025/01/27 | Official source ↗ |
| Novartis Pharma Schweiz AG | Y20190009107 | 2024/10/17 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190003577 | 2025/02/28 | Official source ↗ |
| Teva API India Private Limited | Y20180001125 | 2025/03/20 | 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 ↗ · 27-143 · 2020/06/04
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