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Sign in to subscribeLinaclotide Capsules
Matched- Active ingredients (original)
- LINACLOTIDE
- Dosage form (original)
- CAPSULE
- 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 approval2012/08/30
ANDA applications3
RLD applicantABBVIE INC
Currently marketed products: 4 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A209564-001 | LINACLOTIDE | MYLAN PHARMACEUTICALS INC | CAPSULE | ORAL | LINACLOTIDE: 145MCG | 2021/02/09 | N / N | DISCONTINUED | openFDA ↗ |
| A209564-002 | LINACLOTIDE | MYLAN PHARMACEUTICALS INC | CAPSULE | ORAL | LINACLOTIDE: 290MCG | 2021/02/09 | N / N | DISCONTINUED | openFDA ↗ |
| A209611-001 | LINACLOTIDE | AUROBINDO PHARMA LTD | CAPSULE | ORAL | LINACLOTIDE: 145MCG | 2023/02/07 | N / N | DISCONTINUED | openFDA ↗ |
| A209611-002 | LINACLOTIDE | AUROBINDO PHARMA LTD | CAPSULE | ORAL | LINACLOTIDE: 290MCG | 2023/02/07 | N / N | DISCONTINUED | openFDA ↗ |
| A211255-001 | LINACLOTIDE | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | CAPSULE | ORAL | LINACLOTIDE: 72MCG | 2026/09/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202811-001 | LINZESS | ABBVIE INC | CAPSULE | ORAL | LINACLOTIDE: 145MCG | 2012/08/30 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202811-002 | LINZESS | ABBVIE INC | CAPSULE | ORAL | LINACLOTIDE: 290MCG | 2012/08/30 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N202811-003 | LINZESS | ABBVIE INC | CAPSULE | ORAL | LINACLOTIDE: 72MCG | 2017/01/25 | 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 expiration2034/02/16This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2026/08/30
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 |
|---|---|---|---|---|---|---|
| N202811-001 | 7304036 | 2026/08/30 | Y / Y | U-4345 | — | openFDA ↗ |
| N202811-001 | 7304036*PED | 2027/02/28 | — / — | — | — | openFDA ↗ |
| N202811-001 | 8748573 | 2031/10/30 | — / — | U-4345 | — | openFDA ↗ |
| N202811-001 | 8748573*PED | 2032/04/30 | — / — | — | — | openFDA ↗ |
| N202811-001 | 8802628 | 2031/10/30 | — / Y | — | — | openFDA ↗ |
| N202811-001 | 8802628*PED | 2032/04/30 | — / — | — | — | openFDA ↗ |
| N202811-001 | 8933030 | 2031/02/17 | — / Y | U-4345 | — | openFDA ↗ |
| N202811-001 | 8933030*PED | 2031/08/17 | — / — | — | — | openFDA ↗ |
| N202811-001 | 9708371 | 2033/08/16 | — / Y | U-4345 | — | openFDA ↗ |
| N202811-001 | 9708371*PED | 2034/02/16 | — / — | — | — | openFDA ↗ |
| N202811-002 | 7304036 | 2026/08/30 | Y / Y | U-1278 | — | openFDA ↗ |
| N202811-002 | 7304036*PED | 2027/02/28 | — / — | — | — | openFDA ↗ |
| N202811-002 | 8748573 | 2031/10/30 | — / — | U-1516 | — | openFDA ↗ |
| N202811-002 | 8748573*PED | 2032/04/30 | — / — | — | — | openFDA ↗ |
| N202811-002 | 8802628 | 2031/10/30 | — / Y | — | — | openFDA ↗ |
| N202811-002 | 8802628*PED | 2032/04/30 | — / — | — | — | openFDA ↗ |
| N202811-002 | 8933030 | 2031/02/17 | — / Y | — | — | openFDA ↗ |
| N202811-002 | 8933030*PED | 2031/08/17 | — / — | — | — | openFDA ↗ |
| N202811-002 | 9708371 | 2033/08/16 | — / Y | U-1515 | — | openFDA ↗ |
| N202811-002 | 9708371*PED | 2034/02/16 | — / — | — | — | openFDA ↗ |
| N202811-003 | 10675325 | 2031/08/11 | — / Y | — | — | openFDA ↗ |
| N202811-003 | 10675325*PED | 2032/02/11 | — / — | — | — | openFDA ↗ |
| N202811-003 | 10702576 | 2031/08/11 | — / — | U-3644 | — | openFDA ↗ |
| N202811-003 | 10702576*PED | 2032/02/11 | — / — | — | — | openFDA ↗ |
| N202811-003 | 7304036 | 2026/08/30 | Y / Y | U-3644 | — | openFDA ↗ |
| N202811-003 | 7304036*PED | 2027/02/28 | — / — | — | — | openFDA ↗ |
| N202811-003 | 8933030 | 2031/02/17 | — / Y | U-3644 | — | openFDA ↗ |
| N202811-003 | 8933030*PED | 2031/08/17 | — / — | — | — | openFDA ↗ |
| N202811-003 | 9708371 | 2033/08/16 | — / Y | U-3644 | — | openFDA ↗ |
| N202811-003 | 9708371*PED | 2034/02/16 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2029/05/21
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N202811-001 | I-921 | 2026/06/12 | openFDA ↗ |
| N202811-001 | NPP | 2028/11/04 | openFDA ↗ |
| N202811-001 | PED | 2029/05/04 | openFDA ↗ |
| N202811-003 | I-921 | 2026/06/12 | openFDA ↗ |
| N202811-003 | NPP | 2029/05/21 | openFDA ↗ |
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 |
|---|---|---|---|
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H20266125290μg | 2026/09/29 | Official source ↗ |
| Chengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanized | 国药准字H20265774290μg | 2026/09/02 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20264831290μg | 2026/06/17 | Official source ↗ |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265356290μg | 2026/07/28 | Official source ↗ |
NHSA approval numbers 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Almac Pharma Services Limited | 国药准字J20200012290μg | — | Official source ↗ |
| AstraZeneca AG | 国药准字HJ20190001290μg | — | Official source ↗ |
| Almac Pharma Services Limited | H20190002290μg | — | Official source ↗ |
| AstraZeneca AG | 国药准字HJ20190001290μg | — | Official source ↗ |
| Almac Pharma Services Limited | H20190002290μg | — | Official source ↗ |
Under review 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Qilu Pharmaceutical (Hainan) Co., Ltd | CYHS2300919 | 2023/03/28 | Official source ↗ |
| Suzhou Erye Pharmaceutical Co., Ltd | CYHS2502007 | 2025/06/06 | Official source ↗ |
| Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CYHS2601201 | 2026/05/27 | Official source ↗ |
| Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2502478 | 2025/07/11 | Official source ↗ |
| Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized; Jiangsu Fei Ma Pharma Co., Ltd. romanized | CYHS2302540 | 2023/09/20 | Official source ↗ |
| Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized; Name not romanized | CYHS2602110 | 2026/08/25 | Official source ↗ |
| Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | CYHS2602062 | 2026/08/20 | Official source ↗ |
| Zhejiang Hang Kang Pharma Co., Ltd. romanized | CYHS2600113 | 2026/01/09 | Official source ↗ |
| Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Name not romanized | CYHS2503547 | 2025/09/28 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2503362 | 2025/09/10 | Official source ↗ |
| Shuang He Pharma (Hainan) Co., Ltd. romanized | CYHS2403334 | 2024/10/09 | Official source ↗ |
| You Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | CYHS2602627 | 2026/10/26 | Official source ↗ |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | CYHS2602670 | 2026/11/02 | Official source ↗ |
Generic-filing companies this year 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CYHS2601201 | 2026/05/27 | Official source ↗ |
| Shaanxi Han Tang Pharmaceutical Co., Ltd. romanized; Name not romanized | CYHS2602110 | 2026/08/25 | Official source ↗ |
| Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | CYHS2602062 | 2026/08/20 | Official source ↗ |
| Zhejiang Hang Kang Pharma Co., Ltd. romanized | CYHS2600113 | 2026/01/09 | Official source ↗ |
| You Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | CYHS2602627 | 2026/10/26 | Official source ↗ |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | CYHS2602670 | 2026/11/02 | Official source ↗ |
API companies with A status 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Gowell Pharmaceutical Co., Ltd. | Y20240000603 | 2026/04/29 | Official source ↗ |
| Chengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanized | Y20240000089 | 2026/03/02 | Official source ↗ |
| Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized | Y20230000696 | 2025/09/09 | Official source ↗ |
| Han Yu Pharma (Wuhan) Co., Ltd. romanized | Y20220000680 | 2026/06/21 | Official source ↗ |
| Zhong Tai Sheng Hua Co., Ltd. romanized | Y20210000906 | 2025/08/01 | 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 ↗ · 27-431 · 2020/06/04
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