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Matched- Active ingredients (original)
- IOVERSOL
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
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 approval1988/12/30
ANDA applications0
RLD applicantLIEBEL-FLARSHEIM CO LLC
Currently marketed products: 5 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| N019710-001 | OPTIRAY 320 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 68% | 1988/12/30 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019710-002 | OPTIRAY 240 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 51% | 1988/12/30 | Y / N | DISCONTINUED | openFDA ↗ |
| N019710-003 | OPTIRAY 160 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 34% | 1988/12/30 | N / N | DISCONTINUED | openFDA ↗ |
| N019710-004 | OPTIRAY 300 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 64% | 1992/01/22 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019710-005 | OPTIRAY 350 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 74% | 1992/01/22 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020923-001 | OPTIRAY 240 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 51% | 1998/05/28 | N / N | DISCONTINUED | openFDA ↗ |
| N020923-002 | OPTIRAY 320 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 68% | 1998/05/29 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020923-003 | OPTIRAY 350 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 74% | 1998/05/28 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020923-004 | OPTIRAY 300 | LIEBEL-FLARSHEIM CO LLC | INJECTABLE | INJECTION | IOVERSOL: 64% | 1999/05/13 | 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 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20264614100ml：35g（I） | 2026/06/03 | Official source ↗ |
| Beijing Bei Lu Pharma Co., Ltd. romanized | 国药准字H20264260100ml:35g（I） | 2026/05/07 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2026385750ml:16g (I) | 2026/04/07 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20263858100ml:35g (I) | 2026/04/07 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20255460100ml：32g（I） | 2025/09/09 | Official source ↗ |
| Shanghai Si Tai Li Pharmaceutical Co., Ltd. romanized | 国药准字H20258146100ml:35g(I) | 2025/07/31 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20249483100ml:32g(I) | 2024/12/01 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2024948250ml:16g(I) | 2024/12/01 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20243653100ml:35g(I) | 2024/04/30 | Official source ↗ |
| Shanghai Si Tai Li Pharmaceutical Co., Ltd. romanized | 国药准字H20234353100ml:32g(I) | 2023/10/24 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20143027100ml：35g（I） | 2023/06/08 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2006789520ml：6.4g（I） | 2023/06/08 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20113430100ml：32g（I） | 2023/06/08 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2006789650ml:16g(I) | 2021/08/23 | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H2015057150mL:17.5g（I） | 1999/03/02 | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H20150568100mL:32g（I） | 1999/03/02 | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H20150572;H20150574100mL:35g（I） | 1999/03/02 | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H2015056620mL:6.4g（I） | 1999/03/02 | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H2015056750mL:16g（I） | 1999/03/02 | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265795100ml：35g（I） | 2026/09/02 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H2026580050ml:16g（I） | 2026/09/02 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20265801100ml:35g（I） | 2026/09/02 | Official source ↗ |
NHSA approval numbers 26
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Bei Lu Pharma Co., Ltd. romanized | 国药准字H20264260100ml:35g(I) | — | Official source ↗ |
| Shanghai Si Tai Li Pharmaceutical Co., Ltd. romanized | 国药准字H20234353100ml:32g(I) | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2026385750ml:16g (I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20113430100ml: 32g(I) | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20265801100ml:35g(I) | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20243653100ml:35g(I) | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20264614100ml:35g(I) | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20255460100ml:32g(I) | — | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265795100ml:35g(I) | — | Official source ↗ |
| Chongqing Yu Yang Pharma Co., Ltd. romanized | 国药准字H20255433100ml:32g(I) | — | Official source ↗ |
| Shanghai Si Tai Li Pharmaceutical Co., Ltd. romanized | 国药准字H20234353100ml:32g(I) | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20265801100ml:35g(I) | — | Official source ↗ |
| Shanghai Si Tai Li Pharmaceutical Co., Ltd. romanized | 国药准字H20258146100ml:35g(I) | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20263858100ml:35g (I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20143027100ml: 35g(I) | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H2026580050ml:16g(I) | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2024948250ml:16g(I) | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H2026580050ml:16g(I) | — | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H20150574100mL:35g(I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2006789520ml:6.4g(I) | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20249483100ml:32g(I) | — | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H20150570125mL:40g(I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2006789520ml:6.4g(I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2006789650ml:16g(I) | — | Official source ↗ |
| Liebel-Flarsheim Canada Inc. | H2015056620mL:6.4g(I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2026916975ml:26.25g(I) | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2026916975ml:26.25g(I) | — | Official source ↗ |
| GUERBET | 国药准字HJ2015056750ml:16g(I) | — | Official source ↗ |
| GUERBET | 国药准字HJ2015057150ml:17.5g(I) | — | Official source ↗ |
| GUERBET | 国药准字HJ20150568100ml:32g(I) | — | Official source ↗ |
| GUERBET | 国药准字HJ20150572100ml:35g(I) | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Jia He Pharma Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | CYHS2502389 | 2025/07/05 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | CYHB2601911 | 2026/10/19 | Official source ↗ |
| Shanghai Si Tai Li Pharmaceutical Co., Ltd. romanized | CYHB2601803 | 2026/09/23 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601458 | 2026/06/18 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601457 | 2026/06/18 | Official source ↗ |
| Fujian Sen Fu Run Pharmaceuticals Technology Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd | CYHS2600254 | 2026/01/22 | Official source ↗ |
| Fujian Sen Fu Run Pharmaceuticals Technology Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd | CYHS2504040 | 2025/11/22 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | CYHS2503723 | 2025/10/17 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2502971 | 2025/08/14 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601458 | 2026/06/18 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601457 | 2026/06/18 | Official source ↗ |
| Fujian Sen Fu Run Pharmaceuticals Technology Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd | CYHS2600254 | 2026/01/22 | Official source ↗ |
API companies with A status 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangxi Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20240001006 | 2026/02/13 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20230001115 | 2026/02/07 | Official source ↗ |
| Jiangsu Yu Tian Pharmaceuticals Co., Ltd. romanized | Y20220001089 | 2026/10/29 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004699 | 2026/07/16 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20220000014 | 2025/12/12 | Official source ↗ |
| Zhejiang Si Tai Li Pharmaceutical Co., Ltd. romanized | Y20180000462 | 2023/12/08 | 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.
Formulation crosswalk to INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-076. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 22-107 · 2021/12/15
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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