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Sign in to subscribeEmedastine Difumarate Eye Drops
Matched- Active ingredients (original)
- EMEDASTINE DIFUMARATE
- Dosage form (original)
- SOLUTION/DROPS
- Route (original)
- OPHTHALMIC
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 approval1997/12/29
ANDA applications0
RLD applicantNOVARTIS PHARMACEUTICALS CORP
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 |
|---|---|---|---|---|---|---|---|---|---|
| N020706-001 | EMADINE | NOVARTIS PHARMACEUTICALS CORP | SOLUTION/DROPS | OPHTHALMIC | EMEDASTINE DIFUMARATE: 0.05% | 1997/12/29 | 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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20264363See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20265504See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264359See source | — | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H20065638See source | — | Official source ↗ |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255203See source | — | Official source ↗ |
| Future Health Pharma GmbH | 国药准字HJ20181192See source | — | Official source ↗ |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20258020See source | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254975See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20265504See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20264359See source | — | Official source ↗ |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255203See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20265504See source | — | Official source ↗ |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255203See source | — | Official source ↗ |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255203See source | — | Official source ↗ |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20269166See source | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Yuan Heng Pharma Co., Ltd. romanized | CYHS2600924 | 2026/04/22 | Official source ↗ |
| Sichuan Jian Lin Pharma Co., Ltd. romanized; Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2601751 | 2026/07/21 | Official source ↗ |
| Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized; Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | CYHS2601726 | 2026/07/20 | Official source ↗ |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2600832 | 2026/04/11 | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHS2600580 | 2026/02/28 | Official source ↗ |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2504223 | 2025/12/09 | Official source ↗ |
| Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHS2504201 | 2025/12/06 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2602667 | 2026/10/30 | Official source ↗ |
| Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602671 | 2026/11/02 | Official source ↗ |
Generic-filing companies this year 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Yuan Heng Pharma Co., Ltd. romanized | CYHS2600924 | 2026/04/22 | Official source ↗ |
| Sichuan Jian Lin Pharma Co., Ltd. romanized; Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2601751 | 2026/07/21 | Official source ↗ |
| Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized; Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | CYHS2601726 | 2026/07/20 | Official source ↗ |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2600832 | 2026/04/11 | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | CYHS2600580 | 2026/02/28 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2602667 | 2026/10/30 | Official source ↗ |
| Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602671 | 2026/11/02 | Official source ↗ |
API companies with A status 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanized | Y20240000093 | 2026/10/29 | Official source ↗ |
| Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20220001078 | 2025/03/13 | Official source ↗ |
| Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20220000635 | 2025/07/08 | Official source ↗ |
| SHIRATORI Pharmaceutical Co., Ltd. | Y20210001142 | 2025/08/31 | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | Y20190001397 | 2024/09/04 | Official source ↗ |
| Sichuan De Feng Pharma Co., Ltd. romanized | Y20190001284 | 2023/03/24 | Official source ↗ |
| Sichuan De Feng Pharma Co., Ltd. romanized | Y20180001755 | 2023/10/31 | 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 SOLUTION/DROPS / OPHTHALMIC, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-039. Chinese Pharmacopoeia general chapter 0105
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 27-441 · 2021/08/23
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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