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Sign in to subscribeTrazodone Hydrochloride Sustained-release Tablets
Matched- Active ingredients (original)
- TRAZODONE HYDROCHLORIDE
- 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 approval2010/02/02
ANDA applications0
RLD applicantANGELINI PHARMA INC
Currently marketed products: 0 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| N022411-001 | OLEPTRO | ANGELINI PHARMA INC | TABLET, EXTENDED RELEASE | ORAL | TRAZODONE HYDROCHLORIDE: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2010/02/02 | Y / N | DISCONTINUED | openFDA ↗ |
| N022411-002 | OLEPTRO | ANGELINI PHARMA INC | TABLET, EXTENDED RELEASE | ORAL | TRAZODONE HYDROCHLORIDE: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2010/02/02 | Y / N | DISCONTINUED | openFDA ↗ |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 expiration2029/03/13
Substance patent expiration (DS flag)2029/03/13
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 |
|---|---|---|---|---|---|---|
| N022411-001 | 7829120 | 2027/03/27 | — / Y | U-796 | — | openFDA ↗ |
| N022411-001 | 8133893 | 2029/03/13 | Y / Y | — | — | openFDA ↗ |
| N022411-002 | 7829120 | 2027/03/27 | — / Y | U-796 | — | openFDA ↗ |
| N022411-002 | 8133893 | 2029/03/13 | Y / Y | — | — | openFDA ↗ |
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 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264956See source | 2026/06/23 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957See source | 2026/06/23 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979150mg | 2026/06/23 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907150mg | 2026/04/07 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026390875mg | 2026/04/07 | Official source ↗ |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | 国药准字H20255489See source | 2025/09/16 | Official source ↗ |
NHSA approval numbers 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979See source | — | Official source ↗ |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ2020005175mg | — | Official source ↗ |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | 国药准字H20255489See source | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264956See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979See source | — | Official source ↗ |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ2020005175mg | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264956See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20264979See source | — | Official source ↗ |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ2020005175mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263908See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907See source | — | Official source ↗ |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200052150mg | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907See source | — | Official source ↗ |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200052150mg | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907See source | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264957See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263907See source | — | Official source ↗ |
Under review 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600176 | 2026/01/14 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602191 | 2026/09/02 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602190 | 2026/09/02 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | CYHS2601183 | 2026/05/20 | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2601909 | 2026/08/05 | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | CYHS2601665 | 2026/07/13 | Official source ↗ |
| Zhao Ke Pharma (Guangzhou) Co., Ltd. romanized | CYHS2601349 | 2026/06/09 | Official source ↗ |
| Zhao Ke Pharma (Guangzhou) Co., Ltd. romanized | CYHS2601348 | 2026/06/09 | Official source ↗ |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601039 | 2026/05/08 | Official source ↗ |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601038 | 2026/05/08 | Official source ↗ |
| Shenyang Xin Rui Pharmaceutical Co., Ltd. romanized | CYHS2600444 | 2026/02/11 | Official source ↗ |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized | CYHS2504439 | 2025/12/27 | Official source ↗ |
| Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | CYHS2503449 | 2025/09/18 | Official source ↗ |
| Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized | CYHS2503145 | 2025/08/27 | Official source ↗ |
| Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized | CYHS2503144 | 2025/08/27 | Official source ↗ |
| Hefei Li Cheng Pharma Co., Ltd. romanized | CYHS2503001 | 2025/08/16 | Official source ↗ |
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2502786 | 2025/08/02 | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | CYHS2502782 | 2025/08/02 | Official source ↗ |
| Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2502179 | 2025/06/18 | Official source ↗ |
| Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2502178 | 2025/06/18 | Official source ↗ |
Generic-filing companies this year 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600176 | 2026/01/14 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602191 | 2026/09/02 | Official source ↗ |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602190 | 2026/09/02 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | CYHS2601183 | 2026/05/20 | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2601909 | 2026/08/05 | Official source ↗ |
| Beijing Hua Su Pharmaceutical Co., Ltd. romanized | CYHS2601665 | 2026/07/13 | Official source ↗ |
| Zhao Ke Pharma (Guangzhou) Co., Ltd. romanized | CYHS2601349 | 2026/06/09 | Official source ↗ |
| Zhao Ke Pharma (Guangzhou) Co., Ltd. romanized | CYHS2601348 | 2026/06/09 | Official source ↗ |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601039 | 2026/05/08 | Official source ↗ |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601038 | 2026/05/08 | Official source ↗ |
| Shenyang Xin Rui Pharmaceutical Co., Ltd. romanized | CYHS2600444 | 2026/02/11 | Official source ↗ |
API companies with A status 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000132 | 2026/09/12 | Official source ↗ |
| Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20230001003 | 2026/06/02 | Official source ↗ |
| Medilux Laboratories Pvt. Ltd. | Y20220000900 | 2026/09/16 | Official source ↗ |
| AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA | Y20220000333 | 2025/09/15 | Official source ↗ |
| Matrix Pharmacorp Private Limited | Y20210000921 | 2026/09/16 | Official source ↗ |
| Piramal Pharma Limited | Y20210000635 | 2023/08/14 | Official source ↗ |
| Changzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | Y20190004670 | 2025/07/24 | Official source ↗ |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | Y20190002723 | 2024/07/03 | 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 ↗ · 59-49 · 2022/10/11
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