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Sign in to subscribeDoxazosin Mesylate Extended Release Tablets
Matched- Active ingredients (original)
- DOXAZOSIN MESYLATE
- 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 approval2005/02/22
ANDA applications0
RLD applicantVIATRIS SPECIALTY LLC
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 |
|---|---|---|---|---|---|---|---|---|---|
| N021269-001 | CARDURA XL | VIATRIS SPECIALTY LLC | TABLET, EXTENDED RELEASE | ORAL | DOXAZOSIN MESYLATE: EQ 4MG BASE | 2005/02/22 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021269-002 | CARDURA XL | VIATRIS SPECIALTY LLC | TABLET, EXTENDED RELEASE | ORAL | DOXAZOSIN MESYLATE: EQ 8MG BASE | 2005/02/22 | 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 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Henan Fu Sen Pharma Co., Ltd. romanized | 国药准字H20265126See source | 2026/07/08 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264172See source | 2026/04/29 | Official source ↗ |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263175See source | 2026/01/20 | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20254756See source | 2025/06/30 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20253807See source | 2025/04/01 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H20244353See source | 2024/06/28 | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20243226See source | 2024/02/23 | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20103571See source | 2023/12/13 | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20233964See source | 2023/07/25 | Official source ↗ |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20233967See source | 2023/07/25 | Official source ↗ |
| Pfizer Pharma PFE GmbH | H20170174;H201701754mg | 2001/06/29 | Official source ↗ |
NHSA approval numbers 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H20244353See source | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20254756See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20253807See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264172See source | — | Official source ↗ |
| Henan Fu Sen Pharma Co., Ltd. romanized | 国药准字H20265126See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20243226See source | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20103571See source | — | Official source ↗ |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20233967See source | — | Official source ↗ |
| Pfizer Pharma PFE GmbH | 国药准字J201401304mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20233964See source | — | Official source ↗ |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263175See source | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20254756See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264172See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20243226See source | — | Official source ↗ |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20233967See source | — | Official source ↗ |
| Viatris Pharma GmbH | 国药准字HJ201701754mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20233964See source | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20254756See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20243226See source | — | Official source ↗ |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20233967See source | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20233964See source | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20254756See source | — | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20243226See source | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20103571See source | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20233964See source | — | Official source ↗ |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263175See source | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20103571See source | — | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20103571See source | — | Official source ↗ |
Under review 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | CYHS2502476 | 2025/07/11 | Official source ↗ |
| Hui Zhi Pharmaceutical (Da Lian) Co., Ltd. romanized | CYHS2600416 | 2026/02/10 | Official source ↗ |
| Shanghai Xin Yi Bai Lu Da Pharma Co., Ltd. romanized | CYHS2600147 | 2026/01/13 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hui Zhi Pharmaceutical (Da Lian) Co., Ltd. romanized | CYHS2600416 | 2026/02/10 | Official source ↗ |
| Shanghai Xin Yi Bai Lu Da Pharma Co., Ltd. romanized | CYHS2600147 | 2026/01/13 | Official source ↗ |
API companies with A status 14
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Viatris Pharma GmbH | Y20230001002 | 2026/02/24 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20220000910 | 2026/01/28 | Official source ↗ |
| Apitoria Pharma Private Limited | Y20210000707 | 2025/12/12 | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20220000380 | 2026/07/16 | Official source ↗ |
| 'Srini Pharmaceuticals Private Limited | Y20200000857 | 2023/02/23 | Official source ↗ |
| Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20190007511 | 2024/02/05 | Official source ↗ |
| Yi Bin Hong Guang Pharmaceutical Factory romanized | Y20190005693 | — | Official source ↗ |
| Kang Mei Pharma Co., Ltd. romanized | Y20190003931 | — | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20190003560 | 2025/05/07 | Official source ↗ |
| Tao Sheng Pharmaceutical Co., Ltd. romanized | Y20190003173 | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20190003031 | — | Official source ↗ |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Y20190002529 | — | Official source ↗ |
| Zhejiang Di Er Pharma Co., Ltd. romanized | Y20190002528 | 2025/04/22 | Official source ↗ |
| Zhejiang Xin Sai Ke Pharma Co., Ltd. romanized | Y20170000552 | 2024/05/06 | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20170000322 | 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 ↗ · 56-59 · 2022/09/13
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