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Matched- Active ingredients (original)
- MONTELUKAST SODIUM
- 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 approval1998/02/20
ANDA applications23
RLD applicantORGANON LLC A SUB OF ORGANON AND CO
Currently marketed products: 17 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A078605-001 | MONTELUKAST SODIUM | TEVA PHARMACEUTICALS USA | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A079103-001 | MONTELUKAST SODIUM | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | DISCONTINUED | openFDA ↗ |
| A090655-001 | MONTELUKAST SODIUM | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | DISCONTINUED | openFDA ↗ |
| A090926-001 | MONTELUKAST SODIUM | GLENMARK PHARMACEUTICALS LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091576-001 | MONTELUKAST SODIUM | STRIDES PHARMA INTERNATIONAL AG | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | DISCONTINUED | openFDA ↗ |
| A200889-001 | MONTELUKAST SODIUM | AIPING PHARMACEUTICAL INC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201294-001 | MONTELUKAST SODIUM | APOTEX CORP | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | DISCONTINUED | openFDA ↗ |
| A201515-001 | MONTELUKAST SODIUM | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201522-001 | MONTELUKAST SODIUM | CHARTWELL MOLECULAR HOLDINGS LLC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201582-001 | MONTELUKAST SODIUM | DR REDDYS LABORATORIES LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202468-001 | MONTELUKAST SODIUM | AUROBINDO PHARMA LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202717-001 | MONTELUKAST SODIUM | ACCORD HEALTHCARE INC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2012/09/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202843-001 | MONTELUKAST SODIUM | HETERO LABS LTD UNIT V | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2014/09/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202859-001 | MONTELUKAST SODIUM | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2014/10/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203366-001 | MONTELUKAST SODIUM | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2014/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203432-001 | MONTELUKAST SODIUM | AJANTA PHARMA LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2015/07/31 | N / N | DISCONTINUED | openFDA ↗ |
| A204290-001 | MONTELUKAST SODIUM | UNICHEM LABORATORIES LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2015/10/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204604-001 | MONTELUKAST SODIUM | AMNEAL PHARMACEUTICALS | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2015/09/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205319-001 | MONTELUKAST SODIUM | BRECKENRIDGE PHARMACEUTICAL INC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2020/10/30 | N / N | DISCONTINUED | openFDA ↗ |
| A205683-001 | MONTELUKAST SODIUM | ANBISON LABORATORY CO LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2016/01/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206112-001 | MONTELUKAST SODIUM | L PERRIGO CO | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2017/04/26 | N / N | DISCONTINUED | openFDA ↗ |
| A207463-001 | MONTELUKAST SODIUM | CIPLA LTD | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2016/10/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209012-001 | MONTELUKAST SODIUM | RISING PHARMA HOLDINGS INC | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 2017/04/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020829-002 | SINGULAIR | ORGANON LLC A SUB OF ORGANON AND CO | TABLET | ORAL | MONTELUKAST SODIUM: EQ 10MG BASE | 1998/02/20 | 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 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| HETERO LABS LIMITED | 国药准字HJ20250074See source | 2025/06/24 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | 2025/06/10 | Official source ↗ |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249269See source | 2024/11/05 | Official source ↗ |
| Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized | 国药准字H20244582See source | 2024/07/30 | Official source ↗ |
| Xin Dong Sheng Ji Co., Ltd. romanized | 国药准字HC20240003See source | 2024/01/23 | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H2008337210mg | 2022/05/18 | Official source ↗ |
| Sandoz Private Limited | 国药准字HJ20210076See source | 2021/11/03 | Official source ↗ |
| Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20064370See source | 2021/04/13 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | 2020/07/16 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20203046See source | 2020/02/20 | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20183239See source | 2018/07/06 | Official source ↗ |
| Merck Sharp & Dohme B.V. | H2016047310mg | 1999/10/29 | Official source ↗ |
NHSA approval numbers 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20064370See source | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20203046See source | — | Official source ↗ |
| Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized | 国药准字H20244582See source | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H2008337210mg | — | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20183239See source | — | Official source ↗ |
| N.V. Organon | 国药准字J2013004710mg | — | Official source ↗ |
| Sandoz Private Limited | 国药准字HJ20210076See source | — | Official source ↗ |
| HETERO LABS LIMITED | 国药准字HJ20250074See source | — | Official source ↗ |
| Xin Dong Sheng Ji Co., Ltd. romanized | 国药准字HC20240003See source | — | Official source ↗ |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249269See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20064370See source | — | Official source ↗ |
| Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized | 国药准字H20244582See source | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H2008337210mg | — | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20183239See source | — | Official source ↗ |
| N.V. Organon | 国药准字J2013004710mg | — | Official source ↗ |
| Sandoz Private Limited | 国药准字HJ20210076See source | — | Official source ↗ |
| Xin Dong Sheng Ji Co., Ltd. romanized | 国药准字HC20240003See source | — | Official source ↗ |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249269See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20064370See source | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H2008337210mg | — | Official source ↗ |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249269See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized | 国药准字H20064370See source | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H2008337210mg | — | Official source ↗ |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249269See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249269See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20203308See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254487See source | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20203046See source | — | Official source ↗ |
| Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20183239See source | — | Official source ↗ |
| N.V. Organon | 国药准字HJ20181187See source | — | Official source ↗ |
| N.V. Organon | 国药准字HJ20181187See source | — | Official source ↗ |
Under review 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601037 | 2026/05/08 | Official source ↗ |
| Suzhou Yu Shi Pharma Co., Ltd. romanized | CYHS2600197 | 2026/01/16 | Official source ↗ |
| YaoPharma Co., Ltd. | CYHS2501613 | 2025/04/30 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2601037 | 2026/05/08 | Official source ↗ |
| Suzhou Yu Shi Pharma Co., Ltd. romanized | CYHS2600197 | 2026/01/16 | Official source ↗ |
API companies with A status 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Morepen Laboratories Ltd, | Y20240000485 | 2026/06/23 | Official source ↗ |
| Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | Y20240000834 | 2026/02/24 | Official source ↗ |
| Tian Ke (Jing Zhou) Pharmaceutical Co., Ltd. romanized | Y20240000602 | 2026/09/30 | Official source ↗ |
| Hetero Drugs Limited | Y20220000623 | 2025/06/24 | Official source ↗ |
| Di Jia Pharma Group Co., Ltd. romanized | Y20220000801 | 2024/09/07 | Official source ↗ |
| Matrix Pharmacorp Private Limited | Y20190021354 | 2026/09/05 | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | Y20190009838 | — | Official source ↗ |
| Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20190009826 | 2023/03/24 | Official source ↗ |
| Morepen Laboratories Ltd. | Y20190009301 | 2025/01/06 | Official source ↗ |
| Unimark Remedies Limited | Y20190009208 | 2026/07/12 | Official source ↗ |
| Hanmi Fine Chemical Co., Ltd. | Y20190009191 | — | Official source ↗ |
| Mu Dan Jiang Heng Yuan Pharma Co., Ltd. romanized | Y20190006234 | 2024/06/06 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20190000411 | 2025/05/08 | Official source ↗ |
| MSN Pharmachem Private Limited | Y20190000103 | 2026/05/20 | Official source ↗ |
| Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20190000083 | 2026/03/05 | Official source ↗ |
| Tai Yao Chemical Co., Ltd. romanized | Y20170001580 | 2022/09/05 | Official source ↗ |
| Shandong An Xin Pharmaceutical Co., Ltd. romanized | Y20170001337 | 2026/06/21 | Official source ↗ |
| Ai Mei Ke Jian (Zhongguo) Biopharmaceuticals Co., Ltd. romanized | Y20170000985 | 2024/04/30 | Official source ↗ |
| MSN PHARMACHEM PRIVATE LIMITED | Y20170000744 | 2024/12/31 | Official source ↗ |
| Kai Hui Pharma (Shanghai) Co., Ltd. romanized | Y20170000712 | 2022/11/08 | Official source ↗ |
| Guo Yao Group Zhi Jun (Suzhou) Pharmaceutical Co., Ltd. romanized | Y20170000709 | 2022/09/30 | 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 ↗ · 27-349 · 2020/06/04
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