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Sign in to subscribeSitagliptin and Metformin Hydrochloride Extended-release Tablets
Matched- Active ingredients (original)
- METFORMIN HYDROCHLORIDE · SITAGLIPTIN
- 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 approval2024/07/18
ANDA applications0
RLD applicantZYDUS LIFESCIENCES GLOBAL FZE
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 |
|---|---|---|---|---|---|---|---|---|---|
| N216778-001 | ZITUVIMET XR | ZYDUS LIFESCIENCES GLOBAL FZE | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE: 500MG SITAGLIPTIN: 50MG | 2024/07/18 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N216778-002 | ZITUVIMET XR | ZYDUS LIFESCIENCES GLOBAL FZE | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE: 1GM SITAGLIPTIN: 50MG | 2024/07/18 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N216778-003 | ZITUVIMET XR | ZYDUS LIFESCIENCES GLOBAL FZE | TABLET, EXTENDED RELEASE | ORAL | METFORMIN HYDROCHLORIDE: 1GM SITAGLIPTIN: 100MG | 2024/07/18 | 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 19
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265737See source | 2026/08/25 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | 2026/08/11 | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | 2026/08/04 | Official source ↗ |
| Jiangsu Qian Ren Bio Technology Co., Ltd. romanized | 国药准字H20264802See source | 2026/06/17 | Official source ↗ |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20264762See source | 2026/06/10 | Official source ↗ |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20264764See source | 2026/06/10 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20263256See source | 2026/01/27 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255792See source | 2025/12/17 | Official source ↗ |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20256238See source | 2025/12/16 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255793See source | 2025/10/28 | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255807See source | 2025/10/28 | Official source ↗ |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized | 国药准字H20255599See source | 2025/09/30 | Official source ↗ |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20255635See source | 2025/09/30 | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20258134See source | 2025/09/22 | Official source ↗ |
| Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized | 国药准字H20255428See source | 2025/09/09 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20255056See source | 2025/07/30 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20255065See source | 2025/07/30 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20255058See source | 2025/07/30 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20254043See source | 2025/04/30 | Official source ↗ |
| Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20253718See source | 2025/03/25 | Official source ↗ |
| Ningbo Mei Shu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253646See source | 2025/03/18 | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20233556See source | 2023/05/19 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | 2021/12/31 | Official source ↗ |
NHSA approval numbers 24
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20263256See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265737See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20264762See source | — | Official source ↗ |
| Jiangsu Qian Ren Bio Technology Co., Ltd. romanized | 国药准字H20264802See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265737See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265737See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265737See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265737See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20265445See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | — | Official source ↗ |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20264764See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20269199See source | — | Official source ↗ |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H20233556See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20255635See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20255065See source | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20253718See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20254043See source | — | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20256238See source | — | Official source ↗ |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized | 国药准字H20255599See source | — | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255807See source | — | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20258134See source | — | Official source ↗ |
| Guangzhou Yu Dong Health Pharmaceutical Co., Ltd. romanized | 国药准字H20243149See source | — | Official source ↗ |
| Jiangsu Yue Xing Pharma Co., Ltd. romanized | 国药准字H20255428See source | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255792See source | — | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20255056See source | — | Official source ↗ |
| Ningbo Mei Shu Pharma Co., Ltd. romanized | 国药准字H20253646See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20255065See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20254043See source | — | Official source ↗ |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255807See source | — | Official source ↗ |
| Guangzhou Yu Dong Health Pharmaceutical Co., Ltd. romanized | 国药准字H20243149See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20255065See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20255065See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20213961See source | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255793See source | — | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20255058See source | — | Official source ↗ |
Under review 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Yue Xing Pharma Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | CYHB2601535 | 2026/08/11 | Official source ↗ |
| Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2602251 | 2026/09/09 | Official source ↗ |
| Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Shuang Cheng Pharma Co., Ltd. romanized | CYHS2601053 | 2026/05/09 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2601057 | 2026/05/08 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600923 | 2026/04/22 | Official source ↗ |
| Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2600882 | 2026/04/17 | Official source ↗ |
| Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2600881 | 2026/04/17 | Official source ↗ |
| Hua Zhong Pharma Co., Ltd. romanized | CYHS2504418 | 2025/12/26 | Official source ↗ |
| Henan Zhong Jie Pharma Co., Ltd. romanized | CYHS2503846 | 2025/10/31 | Official source ↗ |
| Henan Zhong Jie Pharma Co., Ltd. romanized | CYHS2503845 | 2025/10/31 | Official source ↗ |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2502158 | 2025/06/17 | Official source ↗ |
| Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CYHS2501999 | 2025/06/06 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2602251 | 2026/09/09 | Official source ↗ |
| Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Shuang Cheng Pharma Co., Ltd. romanized | CYHS2601053 | 2026/05/09 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2601057 | 2026/05/08 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600923 | 2026/04/22 | Official source ↗ |
| Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2600882 | 2026/04/17 | Official source ↗ |
| Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2600881 | 2026/04/17 | Official source ↗ |
API companies with A status 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded 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 ↗ · 26-200 · 2019/06/04
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