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Sign in to subscribePirfenidone Tablets
Matched- Active ingredients (original)
- PIRFENIDONE
- 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 approval2017/01/11
ANDA applications14
RLD applicantLEGACY PHARMA INC SEZC
Currently marketed products: 30 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A212078-001 | PIRFENIDONE | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/08/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212078-002 | PIRFENIDONE | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/08/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212403-001 | PIRFENIDONE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | PIRFENIDONE: 267MG | 2023/08/23 | N / N | DISCONTINUED | openFDA ↗ |
| A212403-002 | PIRFENIDONE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | PIRFENIDONE: 801MG | 2023/08/23 | N / N | DISCONTINUED | openFDA ↗ |
| A212560-001 | PIRFENIDONE | SANDOZ INC | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/04/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212560-002 | PIRFENIDONE | SANDOZ INC | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/04/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212570-001 | PIRFENIDONE | AMNEAL EU LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212570-002 | PIRFENIDONE | AMNEAL EU LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212596-001 | PIRFENIDONE | AUROBINDO PHARMA LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2025/08/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212596-002 | PIRFENIDONE | AUROBINDO PHARMA LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2025/08/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212674-001 | PIRFENIDONE | HETERO LABS LTD UNIT V | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/09/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212674-002 | PIRFENIDONE | HETERO LABS LTD UNIT V | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/09/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212680-001 | PIRFENIDONE | MICRO LABS LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/05/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212680-002 | PIRFENIDONE | MICRO LABS LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/05/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212708-001 | PIRFENIDONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/05/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212708-002 | PIRFENIDONE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/05/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212709-001 | PIRFENIDONE | APOTEX INC | TABLET | ORAL | PIRFENIDONE: 267MG | 2023/05/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212709-002 | PIRFENIDONE | APOTEX INC | TABLET | ORAL | PIRFENIDONE: 801MG | 2023/05/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212722-001 | PIRFENIDONE | LAURUS LABS LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/07/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212722-002 | PIRFENIDONE | LAURUS LABS LTD | TABLET | ORAL | PIRFENIDONE: 534MG | 2022/07/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212722-003 | PIRFENIDONE | LAURUS LABS LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/07/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212730-001 | PIRFENIDONE | ACCORD HEALTHCARE INC | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212730-002 | PIRFENIDONE | ACCORD HEALTHCARE INC | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212747-001 | PIRFENIDONE | AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/07/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212747-002 | PIRFENIDONE | AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD | TABLET | ORAL | PIRFENIDONE: 534MG | 2022/07/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212747-003 | PIRFENIDONE | AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/07/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212759-001 | PIRFENIDONE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212759-002 | PIRFENIDONE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/01/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212772-001 | PIRFENIDONE | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | PIRFENIDONE: 267MG | 2022/05/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212772-002 | PIRFENIDONE | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | PIRFENIDONE: 801MG | 2022/05/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208780-001 | ESBRIET | LEGACY PHARMA INC SEZC | TABLET | ORAL | PIRFENIDONE: 267MG | 2017/01/11 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N208780-002 | ESBRIET | LEGACY PHARMA INC SEZC | TABLET | ORAL | PIRFENIDONE: 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2017/01/11 | Y / N | DISCONTINUED | openFDA ↗ |
| N208780-003 | ESBRIET | LEGACY PHARMA INC SEZC | TABLET | ORAL | PIRFENIDONE: 801MG | 2017/01/11 | 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 expiration2037/03/28
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 |
|---|---|---|---|---|---|---|
| N208780-001 | 10188637 | 2037/03/28 | — / Y | — | — | openFDA ↗ |
| N208780-001 | 7566729 | 2029/04/22 | — / — | U-2078 | — | openFDA ↗ |
| N208780-001 | 7635707 | 2029/04/22 | — / — | U-2074 | — | openFDA ↗ |
| N208780-001 | 7767700 | 2027/12/18 | — / — | U-2080 | — | openFDA ↗ |
| N208780-001 | 7816383 | 2030/01/08 | — / — | U-2042 | — | openFDA ↗ |
| N208780-001 | 7910610 | 2030/01/08 | — / — | U-2049 | — | openFDA ↗ |
| N208780-001 | 8013002 | 2030/01/08 | — / — | U-2047 | — | openFDA ↗ |
| N208780-001 | 8084475 | 2030/01/08 | — / — | U-2054 | — | openFDA ↗ |
| N208780-001 | 8318780 | 2030/01/08 | — / — | U-2081 | — | openFDA ↗ |
| N208780-001 | 8383150 | 2028/05/10 | — / Y | U-2361 | — | openFDA ↗ |
| N208780-001 | 8420674 | 2027/12/18 | — / — | U-2079 | — | openFDA ↗ |
| N208780-001 | 8592462 | 2029/04/22 | — / — | U-2057 | — | openFDA ↗ |
| N208780-001 | 8609701 | 2029/04/22 | — / — | U-2067 | — | openFDA ↗ |
| N208780-001 | 8648098 | 2030/01/08 | — / — | U-2052 | — | openFDA ↗ |
| N208780-001 | 8754109 | 2030/01/08 | — / — | U-2053 | — | openFDA ↗ |
| N208780-001 | 8778947 | 2033/08/30 | — / — | U-2044 | — | openFDA ↗ |
| N208780-002 | 10188637 | 2037/03/28 | — / Y | — | — | openFDA ↗ |
| N208780-002 | 7566729 | 2029/04/22 | — / — | U-2269 | — | openFDA ↗ |
| N208780-002 | 7635707 | 2029/04/22 | — / — | U-2075 | — | openFDA ↗ |
| N208780-002 | 7767700 | 2027/12/18 | — / — | U-2080 | — | openFDA ↗ |
| N208780-002 | 7816383 | 2030/01/08 | — / — | U-2050 | — | openFDA ↗ |
| N208780-002 | 7910610 | 2030/01/08 | — / — | U-2049 | — | openFDA ↗ |
| N208780-002 | 8013002 | 2030/01/08 | — / — | U-2082 | — | openFDA ↗ |
| N208780-002 | 8084475 | 2030/01/08 | — / — | U-2054 | — | openFDA ↗ |
| N208780-002 | 8318780 | 2030/01/08 | — / — | U-2081 | — | openFDA ↗ |
| N208780-002 | 8383150 | 2028/05/10 | — / Y | U-2361 | — | openFDA ↗ |
| N208780-002 | 8420674 | 2027/12/18 | — / — | U-2079 | — | openFDA ↗ |
| N208780-002 | 8592462 | 2029/04/22 | — / — | U-2059 | — | openFDA ↗ |
| N208780-002 | 8609701 | 2029/04/22 | — / — | U-2066 | — | openFDA ↗ |
| N208780-002 | 8648098 | 2030/01/08 | — / — | U-2051 | — | openFDA ↗ |
| N208780-002 | 8754109 | 2030/01/08 | — / — | U-2053 | — | openFDA ↗ |
| N208780-002 | 8778947 | 2033/08/30 | — / — | U-2044 | — | openFDA ↗ |
| N208780-003 | 10188637 | 2037/03/28 | — / Y | — | — | openFDA ↗ |
| N208780-003 | 7566729 | 2029/04/22 | — / — | U-2078 | — | openFDA ↗ |
| N208780-003 | 7635707 | 2029/04/22 | — / — | U-2073 | — | openFDA ↗ |
| N208780-003 | 7767700 | 2027/12/18 | — / — | U-2080 | — | openFDA ↗ |
| N208780-003 | 7816383 | 2030/01/08 | — / — | U-2050 | — | openFDA ↗ |
| N208780-003 | 7910610 | 2030/01/08 | — / — | U-2049 | — | openFDA ↗ |
| N208780-003 | 8013002 | 2030/01/08 | — / — | U-2082 | — | openFDA ↗ |
| N208780-003 | 8084475 | 2030/01/08 | — / — | U-2052 | — | openFDA ↗ |
| N208780-003 | 8318780 | 2030/01/08 | — / — | U-2081 | — | openFDA ↗ |
| N208780-003 | 8383150 | 2028/05/10 | — / Y | U-2361 | — | openFDA ↗ |
| N208780-003 | 8420674 | 2027/12/18 | — / — | U-2079 | — | openFDA ↗ |
| N208780-003 | 8592462 | 2029/04/22 | — / — | U-2058 | — | openFDA ↗ |
| N208780-003 | 8609701 | 2029/04/22 | — / — | U-2068 | — | openFDA ↗ |
| N208780-003 | 8648098 | 2030/01/08 | — / — | U-2052 | — | openFDA ↗ |
| N208780-003 | 8754109 | 2030/01/08 | — / — | U-2053 | — | openFDA ↗ |
| N208780-003 | 8778947 | 2033/08/30 | — / — | U-2044 | — | 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 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Kai Yin Technology Co., Ltd. romanized | 国药准字H20193259200mg | 2019/09/11 | Official source ↗ |
NHSA approval numbers 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Kai Yin Technology Co., Ltd. romanized | 国药准字H20193259200mg | — | Official source ↗ |
| Beijing Kai Yin Technology Co., Ltd. romanized | 国药准字H20193259200mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2602065 | 2026/08/20 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602045 | 2026/08/18 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601659 | 2026/07/13 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601361 | 2026/06/10 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHS2602658 | 2026/10/30 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2602065 | 2026/08/20 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602045 | 2026/08/18 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2601659 | 2026/07/13 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601361 | 2026/06/10 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | CYHS2602658 | 2026/10/30 | Official source ↗ |
API companies with A status 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240000922 | 2026/03/13 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20230000430 | 2025/01/15 | Official source ↗ |
| Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20220001113 | 2025/01/13 | Official source ↗ |
| Laurus Labs Limited, (Unit - III) romanized | Y20220000213 | 2024/03/11 | Official source ↗ |
| Amoli Organics (A Division of Umedica Laboratories Private Limited) | Y20210000865 | 2024/06/06 | Official source ↗ |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Y20210000519 | 2023/05/25 | Official source ↗ |
| LUPIN MANUFACTURING SOLUTIONS LIMITED | Y20200001363 | 2026/10/29 | Official source ↗ |
| Cohance Lifesciences Limited | Y20200000918 | 2024/12/27 | Official source ↗ |
| Beijing Kang Di Ni Pharma Co., Ltd. romanized | Y20190007388 | 2023/08/25 | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20170001660 | 2024/04/16 | 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 ↗ · 22-53 · 2019/08/28
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