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Sign in to subscribePentoxifylline Modified Release Tablets
Matched- Active ingredients (original)
- PENTOXIFYLLINE
- Dosage form (original)
- TABLET, EXTENDED RELEASE
- 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 approval1984/08/30
ANDA applications10
RLD applicantVALIDUS PHARMACEUTICALS LLC
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 |
|---|---|---|---|---|---|---|---|---|---|
| A074425-001 | PENTOXIFYLLINE | RISING PHARMA HOLDING INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1997/07/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074874-001 | PENTOXIFYLLINE | PLIVA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1999/05/25 | N / N | DISCONTINUED | openFDA ↗ |
| A074877-001 | PENTOXIFYLLINE | HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1997/07/08 | N / N | DISCONTINUED | openFDA ↗ |
| A074878-001 | PENTOXIFYLLINE | ANI PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1997/07/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074962-001 | PENTOXIL | UPSHER SMITH LABORATORIES LLC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1999/03/31 | N / N | DISCONTINUED | openFDA ↗ |
| A075028-001 | PENTOXIFYLLINE | BAUSCH HEALTH US LLC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1998/07/20 | N / N | DISCONTINUED | openFDA ↗ |
| A075093-001 | PENTOXIFYLLINE | IMPAX LABORATORIES INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1999/08/10 | N / N | DISCONTINUED | openFDA ↗ |
| A075107-001 | PENTOXIFYLLINE | ANI PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1998/09/04 | N / N | DISCONTINUED | openFDA ↗ |
| A075191-001 | PENTOXIFYLLINE | APOTEX INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1999/06/09 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075199-001 | PENTOXIFYLLINE | ANI PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1999/09/03 | N / N | DISCONTINUED | openFDA ↗ |
| N018631-001 | TRENTAL | VALIDUS PHARMACEUTICALS LLC | TABLET, EXTENDED RELEASE | ORAL | PENTOXIFYLLINE: 400MG | 1984/08/30 | Y / N | 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 17
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H202658350.4g | 2026/09/02 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H202656010.4g | 2026/08/04 | Official source ↗ |
| Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized | 国药准字H202650210.4g | 2026/06/30 | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H202648860.4g | 2026/06/17 | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | 2026/06/17 | Official source ↗ |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H202635170.4g | 2026/03/03 | Official source ↗ |
| Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202635160.4g | 2026/03/03 | Official source ↗ |
| Jiangsu Hui Ju Pharma Co., Ltd. romanized | 国药准字H202634730.4g | 2026/02/25 | Official source ↗ |
| Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202560700.4g | 2025/11/25 | Official source ↗ |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H202558830.4g | 2025/11/04 | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H202553770.4g | 2025/09/09 | Official source ↗ |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | 国药准字H202553470.4g | 2025/09/09 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202552550.4g | 2025/08/26 | Official source ↗ |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H202550080.4g | 2025/07/29 | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202548450.4g | 2025/07/15 | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202535440.4g | 2025/03/04 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202333100.4g | 2023/03/21 | Official source ↗ |
NHSA approval numbers 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H202658350.4g | — | Official source ↗ |
| Jiangsu Hui Ju Pharma Co., Ltd. romanized | 国药准字H202634730.4g | — | Official source ↗ |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H202558830.4g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202333100.4g | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H109702650.4g | — | Official source ↗ |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H202550080.4g | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202552550.4g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H202656010.4g | — | Official source ↗ |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H202635170.4g | — | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H202648860.4g | — | Official source ↗ |
| Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized | 国药准字H202560170.4g | — | Official source ↗ |
| Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202560700.4g | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202548450.4g | — | Official source ↗ |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | 国药准字H202553470.4g | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H202553770.4g | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202535440.4g | — | Official source ↗ |
| Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202635160.4g | — | Official source ↗ |
| Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized | 国药准字H202658350.4g | — | Official source ↗ |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H202558830.4g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202333100.4g | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H109702650.4g | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202552550.4g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H202656010.4g | — | Official source ↗ |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H202635170.4g | — | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H202648860.4g | — | Official source ↗ |
| Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized | 国药准字H202560170.4g | — | Official source ↗ |
| Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 国药准字H202560700.4g | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202548450.4g | — | Official source ↗ |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | 国药准字H202553470.4g | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H202553770.4g | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202535440.4g | — | Official source ↗ |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H202558830.4g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202333100.4g | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H109702650.4g | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202552550.4g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H202656010.4g | — | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H202648860.4g | — | Official source ↗ |
| Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized | 国药准字H202560170.4g | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202548450.4g | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H202553770.4g | — | Official source ↗ |
| Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized | 国药准字H202558830.4g | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H109702650.4g | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202552550.4g | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202548450.4g | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H202553770.4g | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H109702650.4g | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | — | Official source ↗ |
| Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized | 国药准字H202553770.4g | — | Official source ↗ |
| Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202648380.4g | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hefei Guo Gao Pharma Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized | CYHB2601752 | 2026/09/17 | Official source ↗ |
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2500044 | 2025/01/04 | Official source ↗ |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized | CYHS2600403 | 2026/02/07 | Official source ↗ |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | CYHS2601283 | 2026/06/04 | Official source ↗ |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2600230 | 2026/01/20 | Official source ↗ |
| Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2403035 | 2024/09/12 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized | CYHS2600403 | 2026/02/07 | Official source ↗ |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | CYHS2601283 | 2026/06/04 | Official source ↗ |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2600230 | 2026/01/20 | Official source ↗ |
API companies with A status 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20240000402 | 2025/12/10 | Official source ↗ |
| Chi Feng Wan Ze Pharma Co., Ltd. romanized | Y20230001239 | 2025/11/03 | Official source ↗ |
| Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized | Y20230000412 | 2025/04/07 | Official source ↗ |
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20230000230 | 2025/08/10 | Official source ↗ |
| SUN PHARMACEUTICAL INDUSTRIES LTD. | Y20220000937 | 2024/11/07 | Official source ↗ |
| Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20220000743 | 2024/08/10 | Official source ↗ |
| Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized | Y20220000799 | 2024/05/30 | Official source ↗ |
| PHARMACEUTICAL WORKS POLPHARMA S.A. | Y20210000211 | 2024/07/09 | Official source ↗ |
| Chongqing Rui Po Lai Pharmaceutical Co., Ltd. romanized | Y20210000669 | 2025/01/27 | Official source ↗ |
| FLEMING LABORATORIES LTD | Y20210000649 | 2025/06/08 | Official source ↗ |
| BAKUL PHARMA PRIVATE LIMITED | Y20200001449 | 2025/12/25 | Official source ↗ |
| Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20200001394 | 2026/10/13 | Official source ↗ |
| SOLARA ACTIVE PHARMA SCIENCES LIMITED | Y20200001064 | 2023/05/16 | Official source ↗ |
| Shi Yao Innovation Pharmaceutical Co., Ltd. romanized | Y20190005020 | 2025/06/12 | Official source ↗ |
| ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Y20170000764 | 2026/07/24 | 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 TABLET, EXTENDED RELEASE / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-003. Chinese Pharmacopoeia general chapter 0101
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 8-71 · 2021/11/12
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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