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Sign in to subscribeMinocycline Hydrochloride Capsules
Matched- Active ingredients (original)
- MINOCYCLINE HYDROCHLORIDE
- 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 approvalApproved before 1982
ANDA applications9
RLD applicantBAUSCH HEALTH US LLC
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 |
|---|---|---|---|---|---|---|---|---|---|
| A063009-001 | MINOCYCLINE HYDROCHLORIDE | ZYDUS WORLDWIDE DMCC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 1992/03/02 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A063009-002 | MINOCYCLINE HYDROCHLORIDE | ZYDUS WORLDWIDE DMCC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 2003/08/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A063011-001 | MINOCYCLINE HYDROCHLORIDE | ZYDUS WORLDWIDE DMCC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 1992/03/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A063065-001 | MINOCYCLINE HYDROCHLORIDE | WATSON LABORATORIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 1991/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A063065-002 | MINOCYCLINE HYDROCHLORIDE | WATSON LABORATORIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 1999/06/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A063067-001 | DYNACIN | ALVOGEN INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 1990/07/31 | N / N | DISCONTINUED | openFDA ↗ |
| A063067-002 | DYNACIN | ALVOGEN INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 1999/09/15 | N / N | DISCONTINUED | openFDA ↗ |
| A063067-003 | DYNACIN | ALVOGEN INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 1990/08/14 | N / N | DISCONTINUED | openFDA ↗ |
| A063181-001 | MINOCYCLINE HYDROCHLORIDE | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 1991/12/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065005-001 | MINOCYCLINE HYDROCHLORIDE | IMPAX LABORATORIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 1999/03/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065005-002 | MINOCYCLINE HYDROCHLORIDE | IMPAX LABORATORIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 1999/03/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065005-003 | MINOCYCLINE HYDROCHLORIDE | IMPAX LABORATORIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 2001/04/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065062-001 | MINOCYCLINE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 2000/11/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065062-002 | MINOCYCLINE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 2000/11/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065062-003 | MINOCYCLINE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 2000/11/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065470-001 | MINOCYCLINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 2008/03/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065470-002 | MINOCYCLINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 2008/03/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065470-003 | MINOCYCLINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 2008/03/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090867-001 | MINOCYCLINE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 2013/05/13 | N / N | DISCONTINUED | openFDA ↗ |
| A090867-002 | MINOCYCLINE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE | 2013/05/13 | N / N | DISCONTINUED | openFDA ↗ |
| A090867-003 | MINOCYCLINE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 2013/05/13 | N / N | DISCONTINUED | openFDA ↗ |
| N050315-001 | MINOCIN | TRIAX PHARMACEUTICALS LLC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N050315-002 | MINOCIN | TRIAX PHARMACEUTICALS LLC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N050649-001 | MINOCIN | BAUSCH HEALTH US LLC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 50MG BASE | 1990/05/31 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N050649-002 | MINOCIN | BAUSCH HEALTH US LLC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 100MG BASE | 1990/05/31 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N050649-003 | MINOCIN | BAUSCH HEALTH US LLC | CAPSULE | ORAL | MINOCYCLINE HYDROCHLORIDE: EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2001/02/12 | 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 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | 2026/05/12 | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20264306See source | 2026/05/12 | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | 2026/05/12 | Official source ↗ |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H10920124See source | 2023/03/02 | Official source ↗ |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20174080See source | 1994/12/02 | Official source ↗ |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20174081See source | 1994/12/02 | Official source ↗ |
NHSA approval numbers 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Bai Yun Shan Guang Hua Pharmaceutical Co., Ltd. romanized | 国药准字H44020434See source | — | Official source ↗ |
| Shenzhen Shi Zhong Lian Pharmaceutical Co., Ltd. romanized | 国药准字H10940184See source | — | Official source ↗ |
| Shanghai Mei You Pharmaceutical Co., Ltd. romanized | 国药准字H10950348See source | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H10940285See source | — | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H2012331050mg | — | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H20010439See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20083474See source | — | Official source ↗ |
| Kun Yao Group Co., Ltd. romanized | 国药准字H10940017See source | — | Official source ↗ |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H10920124See source | — | Official source ↗ |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20174081See source | — | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20264306See source | — | Official source ↗ |
| Shanghai Mei You Pharmaceutical Co., Ltd. romanized | 国药准字H10950348See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20059110See source | — | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H2012331050mg | — | Official source ↗ |
| Ha Yao Group Pharmaceutical Liu Factory romanized | 国药准字H1094005950mg | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20083474See source | — | Official source ↗ |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H10920124See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20059110See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20083474See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20059110See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Shanghai Hua Yuan Anhui Ren Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20083474See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20059110See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264293See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20059110See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H10920124See source | — | Official source ↗ |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20174080See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264292See source | — | Official source ↗ |
Under review 19
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHB2650007 | 2026/01/07 | Official source ↗ |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHB2650006 | 2026/01/07 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHB2650173 | 2026/08/12 | Official source ↗ |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHB2650172 | 2026/08/12 | Official source ↗ |
| Zhejiang Innovation Bio Co., Ltd. romanized | CYHS2600462 | 2026/02/13 | Official source ↗ |
| Zhejiang Innovation Bio Co., Ltd. romanized | CYHS2600461 | 2026/02/13 | Official source ↗ |
| Shijiazhuang Kang Li Pharma Co., Ltd. romanized | CYHS2600307 | 2026/01/29 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2600165 | 2026/01/13 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2600164 | 2026/01/13 | Official source ↗ |
| Zhuhai Tong Yuan Pharma Co., Ltd. romanized | CYHS2600083 | 2026/01/08 | Official source ↗ |
| Zhuhai Tong Yuan Pharma Co., Ltd. romanized | CYHS2600082 | 2026/01/08 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2503409 | 2025/09/16 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2503408 | 2025/09/16 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2503324 | 2025/09/09 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2503323 | 2025/09/09 | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Beijing Ya Bao Bio Pharma Co., Ltd. romanized | CYHS2503233 | 2025/09/02 | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2501367 | 2025/04/09 | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2501366 | 2025/04/09 | Official source ↗ |
| Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized | CYHS2500237 | 2025/01/10 | Official source ↗ |
Generic-filing companies this year 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Innovation Bio Co., Ltd. romanized | CYHS2600462 | 2026/02/13 | Official source ↗ |
| Zhejiang Innovation Bio Co., Ltd. romanized | CYHS2600461 | 2026/02/13 | Official source ↗ |
| Shijiazhuang Kang Li Pharma Co., Ltd. romanized | CYHS2600307 | 2026/01/29 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2600165 | 2026/01/13 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | CYHS2600164 | 2026/01/13 | Official source ↗ |
| Zhuhai Tong Yuan Pharma Co., Ltd. romanized | CYHS2600083 | 2026/01/08 | Official source ↗ |
| Zhuhai Tong Yuan Pharma Co., Ltd. romanized | CYHS2600082 | 2026/01/08 | Official source ↗ |
API companies with A status 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hai Zheng Pharma Nan Tong Co., Ltd. romanized | Y20240000032 | 2026/09/29 | Official source ↗ |
| HOVIONE FARMACIENCIA S.A. | Y20230000723 | 2025/10/14 | Official source ↗ |
| Zhejiang Chang Hai Pharmaceutical Co., Ltd. romanized | Y20220000076 | 2025/09/09 | Official source ↗ |
| CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. | Y20210000751 | 2024/07/26 | Official source ↗ |
| CURIA ITALY S.R.L. | Y20190008989 | 2026/09/03 | Official source ↗ |
| Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20190004294 | 2024/10/01 | 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 ↗ · 14-1 · 2019/02/27
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