Monthly
US$200
Billed every month
Sign in to subscribeDoxycycline Hyclate for Injection
Matched- Active ingredients (original)
- DOXYCYCLINE HYCLATE
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
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 applications19
RLD applicantPFIZER LABORATORIES DIV PFIZER INC
Currently marketed products: 18 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A061953-001 | DOXYCHEL HYCLATE | RACHELLE LABORATORIES INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A062450-001 | DOXYCYCLINE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 1983/10/27 | N / N | DISCONTINUED | openFDA ↗ |
| A062450-002 | DOXYCYCLINE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL | 1983/10/27 | N / N | DISCONTINUED | openFDA ↗ |
| A062475-001 | DOXY 100 | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 1983/12/09 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062475-002 | DOXY 200 | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL | 1983/12/09 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062569-001 | DOXYCYCLINE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 1988/03/09 | N / N | DISCONTINUED | openFDA ↗ |
| A062569-002 | DOXYCYCLINE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL | 1988/03/09 | N / N | DISCONTINUED | openFDA ↗ |
| A062992-001 | DOXYCYCLINE HYCLATE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 1989/02/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062992-002 | DOXYCYCLINE HYCLATE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL | 1989/02/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091406-001 | DOXYCYCLINE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2012/08/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203276-001 | DOXYCYCLINE HYCLATE | AVET LIFESCIENCES PRIVATE LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2026/02/19 | N / N | DISCONTINUED | openFDA ↗ |
| A207757-001 | DOXYCYCLINE | ZYDUS PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2017/09/28 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207757-002 | DOXYCYCLINE | ZYDUS PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL | 2017/09/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215583-001 | DOXYCYCLINE HYCLATE | GLAND PHARMA LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2023/04/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216690-001 | DOXYCYCLINE HYCLATE | PH HEALTH LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2022/12/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217078-001 | DOXYCYCLINE HYCLATE | PHARMOBEDIENT CONSULTING LLC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2025/02/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217487-001 | DOXYCYCLINE HYCLATE | AMNEAL EU LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2024/12/04 | N / N | DISCONTINUED | openFDA ↗ |
| A217685-001 | DOXYCYCLINE HYCLATE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2024/06/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217685-002 | DOXYCYCLINE HYCLATE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL | 2024/06/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217794-001 | DOXYCYCLINE HYCLATE | LUPIN LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2024/03/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217854-001 | DOXYCYCLINE HYCLATE | HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2024/07/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217972-001 | DOXYCYCLINE HYCLATE | STERISCIENCE PTE LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2025/11/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218053-001 | DOXYCYCLINE HYCLATE | KINDOS PHARMACEUTICALS CO LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2024/10/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218753-001 | DOXYCYCLINE HYCLATE | DR REDDYS LABORATORIES LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2025/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218888-001 | DOXYCYCLINE HYCLATE | ASPIRO PHARMA LTD | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL | 2025/08/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N050442-001 | VIBRAMYCIN | PFIZER LABORATORIES DIV PFIZER INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N050442-002 | VIBRAMYCIN | PFIZER LABORATORIES DIV PFIZER INC | INJECTABLE | INJECTION | DOXYCYCLINE HYCLATE: EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | 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 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H202495760.1g | 2024/12/01 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H202495770.2g | 2024/12/01 | Official source ↗ |
| Haikou Qi Li Pharmaceutical Co., Ltd. romanized | 国药准字H20080630See source | 2024/04/29 | Official source ↗ |
| Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized | 国药准字H20060405See source | 2023/04/21 | Official source ↗ |
NHSA approval numbers 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20051974See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20193375See source | — | Official source ↗ |
| Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized | 国药准字H20060405See source | — | Official source ↗ |
| Hainan Ying Da Run Ze Pharma Co., Ltd. romanized | 国药准字H20080630See source | — | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20249576See source | — | Official source ↗ |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20051974See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20193376See source | — | Official source ↗ |
| Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized | 国药准字H20060405See source | — | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20249576See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20193375See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20193376See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20193375See source | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H20193376See source | — | Official source ↗ |
| Hainan Ying Da Run Ze Pharma Co., Ltd. romanized | 国药准字H20080631See source | — | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20249577See source | — | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20249577See source | — | Official source ↗ |
Under review 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized | CYHS2502839 | 2025/08/06 | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2602083 | 2026/08/21 | Official source ↗ |
| Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CYHS2501777 | 2025/05/16 | Official source ↗ |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized | CYHB2601761 | 2026/09/18 | Official source ↗ |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized | CYHB2601760 | 2026/09/18 | Official source ↗ |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | CYHB2650083 | 2026/03/23 | Official source ↗ |
| Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | CYHS2600321 | 2026/01/31 | Official source ↗ |
| Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | CYHS2600319 | 2026/01/31 | Official source ↗ |
| Hubei Mei Lin Pharma Co., Ltd. romanized | CYHS2503467 | 2025/09/19 | Official source ↗ |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized | CYHS2502665 | 2025/07/23 | Official source ↗ |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized | CYHS2502663 | 2025/07/23 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2602083 | 2026/08/21 | Official source ↗ |
| Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | CYHS2600321 | 2026/01/31 | Official source ↗ |
| Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | CYHS2600319 | 2026/01/31 | Official source ↗ |
API companies with A status 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20240001089 | 2026/08/15 | Official source ↗ |
| HOVIONE PHARMASCIENCE LIMITED | Y20220000451 | 2026/05/20 | Official source ↗ |
| Shanghai Qing Ping Pharma Co., Ltd. romanized | Y20190006582 | 2026/01/31 | Official source ↗ |
| Kun Shandong Fang Pharma Co., Ltd. romanized | Y20190006560 | — | Official source ↗ |
| Shijiazhuang Hua Shu Shan He Pharma Co., Ltd. romanized | Y20190006021 | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | Y20190005098 | 2025/02/09 | Official source ↗ |
| Suzhou Di Wu Pharmaceutical Factory Co., Ltd. romanized | Y20190005068 | — | Official source ↗ |
| Yan Cheng Su Hai Pharmaceutical Co., Ltd. romanized | Y20190004892 | 2025/07/18 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20190004505 | 2025/07/09 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190004072 | 2025/07/30 | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190002589 | 2024/09/11 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Y20190002114 | 2025/01/23 | 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 INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-088. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 27-298 · 2020/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy