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Sign in to subscribeSevelamer Carbonate Tablets
Matched- Active ingredients (original)
- SEVELAMER CARBONATE
- 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 approval2007/10/19
ANDA applications16
RLD applicantSANOFI GENZYME
Currently marketed products: 11 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A090975-001 | SEVELAMER CARBONATE | IMPAX LABORATORIES INC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2017/10/23 | N / N | DISCONTINUED | openFDA ↗ |
| A200959-001 | SEVELAMER CARBONATE | QUAGEN PHARMACEUTICALS LLC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2018/03/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201069-001 | SEVELAMER CARBONATE | STRIDES PHARMA INTERNATIONAL AG | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2020/08/05 | N / N | DISCONTINUED | openFDA ↗ |
| A203860-001 | SEVELAMER CARBONATE | INVAGEN PHARMACEUTICALS INC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2017/10/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204451-001 | SEVELAMER CARBONATE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2018/11/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204600-001 | SEVELAMER CARBONATE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2021/01/14 | N / N | DISCONTINUED | openFDA ↗ |
| A206094-001 | SEVELAMER CARBONATE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2017/09/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206100-001 | SEVELAMER CARBONATE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2023/04/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207179-001 | SEVELAMER CARBONATE | AUROBINDO PHARMA LTD | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2017/07/17 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207288-001 | SEVELAMER CARBONATE | AMNEAL PHARMACEUTICALS CO GMBH | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2017/11/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207759-001 | SEVELAMER CARBONATE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2020/08/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211915-001 | SEVELAMER CARBONATE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2024/05/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212970-001 | SEVELAMER CARBONATE | EPIC PHARMA LLC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2020/04/09 | N / N | DISCONTINUED | openFDA ↗ |
| A215537-001 | SEVELAMER CARBONATE | MICRO LABS LTD | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2022/02/07 | N / N | DISCONTINUED | openFDA ↗ |
| A215998-001 | SEVELAMER CARBONATE | SHANDONG XINHUA PHARMACEUTICAL CO LTD | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2024/10/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219931-001 | SEVELAMER CARBONATE | NAVINTA LLC | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2025/10/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N022127-001 | RENVELA | SANOFI GENZYME | TABLET | ORAL | SEVELAMER CARBONATE: 800MG | 2007/10/19 | Y / N | DISCONTINUED | 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 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ202600270.8g | 2026/03/17 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H202635120.8g | 2026/03/03 | Official source ↗ |
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H202559160.8g | 2025/11/12 | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H202559140.8g | 2025/11/12 | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | 2025/11/12 | Official source ↗ |
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | 国药准字H202496350.8g | 2024/12/01 | Official source ↗ |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H202345290.8g | 2023/11/21 | Official source ↗ |
| Aurobindo Pharma Limited | 国药准字HJ202301220.8g | 2023/10/27 | Official source ↗ |
| Shanghai An Xian Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202341690.8g | 2023/09/19 | Official source ↗ |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ202301020.8g | 2023/08/15 | Official source ↗ |
| Name not romanized | 国药准字HJ202300420.8g | 2023/04/28 | Official source ↗ |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H202333470.8g | 2023/03/24 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202332030.8g | 2023/02/21 | Official source ↗ |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202033030.8g | 2020/07/08 | Official source ↗ |
| Genzyme Europe B.V. | H20181037;H20181038;H20181039800mg | 2013/06/03 | Official source ↗ |
NHSA approval numbers 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | 国药准字H202496350.8g | — | Official source ↗ |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H202033030.8g | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202332030.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H202333470.8g | — | Official source ↗ |
| Aurobindo Pharma Limited | 国药准字HJ202301220.8g | — | Official source ↗ |
| Name not romanized | 国药准字HJ202300420.8g | — | Official source ↗ |
| Genzyme Europe B.V. | 国药准字J20130160800mg | — | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H202559140.8g | — | Official source ↗ |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202341690.8g | — | Official source ↗ |
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H202559160.8g | — | Official source ↗ |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H202345290.8g | — | Official source ↗ |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ202301020.8g | — | Official source ↗ |
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ202600270.8g | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H202332030.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Name not romanized | 国药准字HJ202300420.8g | — | Official source ↗ |
| Genzyme Europe B.V. | 国药准字J20130160800mg | — | Official source ↗ |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202341690.8g | — | Official source ↗ |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H202345290.8g | — | Official source ↗ |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ202301020.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Sanofi B.V. | 国药准字HJ20181037800mg | — | Official source ↗ |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H202345290.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Sanofi B.V. | 国药准字HJ20181037800mg | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H202559150.8g | — | Official source ↗ |
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ202600270.8g | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | CYHS2601599 | 2026/07/06 | Official source ↗ |
| Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. | JYHZ2600199 | 2026/08/19 | Official source ↗ |
| Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. | JYHZ2600198 | 2026/08/19 | Official source ↗ |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2600686 | 2026/03/19 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | CYHS2601599 | 2026/07/06 | Official source ↗ |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2600686 | 2026/03/19 | Official source ↗ |
API companies with A status 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Apothecon Pharmaceuticals Pvt.Ltd. | Y20220001050 | 2025/03/06 | Official source ↗ |
| Solara Active Pharma Sciences Limited | Y20220000327 | 2025/11/22 | Official source ↗ |
| Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | Y20220000545 | 2025/07/22 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210000306 | 2024/06/08 | Official source ↗ |
| Apitoria Pharma Private Limited | Y20190000430 | 2025/05/06 | Official source ↗ |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20190000205 | 2025/03/28 | Official source ↗ |
| Formosa Laboratories, Inc. | Y20180001514 | 2026/06/10 | 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 ↗ · 32-45 · 2020/11/23
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