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Milnacipran Hydrochloride Tablets

Matched
Active ingredients (original)
MILNACIPRAN HYDROCHLORIDE
Dosage form (original)
TABLET
Route (original)
ORAL

Read these limits

  1. US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
  2. The Orange Book lists holder-submitted patents and does not cover all related patents.
  3. “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.
  4. This page contains no sales or market-size data and cannot establish development value.
  5. 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 approval2009/01/14
ANDA applications5
RLD applicantABBVIE INC

Currently marketed products: 24 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.

Application / product numberBrand name (original)Applicant (original)Dosage form (original)Route (original)Strength (original)Earliest approvalRLD / RSMarketing status (original)Official source
A205071-001MILNACIPRAN HYDROCHLORIDEBRECKENRIDGE PHARMACEUTICAL INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 12.5MG2016/01/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205071-002MILNACIPRAN HYDROCHLORIDEBRECKENRIDGE PHARMACEUTICAL INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 25MG2016/01/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205071-003MILNACIPRAN HYDROCHLORIDEBRECKENRIDGE PHARMACEUTICAL INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 50MG2016/01/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205071-004MILNACIPRAN HYDROCHLORIDEBRECKENRIDGE PHARMACEUTICAL INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 100MG2016/01/27N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205081-001MILNACIPRAN HYDROCHLORIDEAMNEAL PHARMACEUTICALSTABLETORALMILNACIPRAN HYDROCHLORIDE: 12.5MG2016/04/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205081-002MILNACIPRAN HYDROCHLORIDEAMNEAL PHARMACEUTICALSTABLETORALMILNACIPRAN HYDROCHLORIDE: 25MG2016/04/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205081-003MILNACIPRAN HYDROCHLORIDEAMNEAL PHARMACEUTICALSTABLETORALMILNACIPRAN HYDROCHLORIDE: 50MG2016/04/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205081-004MILNACIPRAN HYDROCHLORIDEAMNEAL PHARMACEUTICALSTABLETORALMILNACIPRAN HYDROCHLORIDE: 100MG2016/04/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205147-001MILNACIPRAN HYDROCHLORIDEHETERO LABS LTD UNIT VTABLETORALMILNACIPRAN HYDROCHLORIDE: 12.5MG2024/10/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205147-002MILNACIPRAN HYDROCHLORIDEHETERO LABS LTD UNIT VTABLETORALMILNACIPRAN HYDROCHLORIDE: 25MG2024/10/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205147-003MILNACIPRAN HYDROCHLORIDEHETERO LABS LTD UNIT VTABLETORALMILNACIPRAN HYDROCHLORIDE: 50MG2024/10/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A205147-004MILNACIPRAN HYDROCHLORIDEHETERO LABS LTD UNIT VTABLETORALMILNACIPRAN HYDROCHLORIDE: 100MG2024/10/03N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207399-001MILNACIPRAN HYDROCHLORIDESTRIDES PHARMA GLOBAL PTE LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 12.5MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207399-002MILNACIPRAN HYDROCHLORIDESTRIDES PHARMA GLOBAL PTE LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 25MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207399-003MILNACIPRAN HYDROCHLORIDESTRIDES PHARMA GLOBAL PTE LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 50MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207399-004MILNACIPRAN HYDROCHLORIDESTRIDES PHARMA GLOBAL PTE LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 100MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A210944-001MILNACIPRAN HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 12.5MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A210944-002MILNACIPRAN HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 25MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A210944-003MILNACIPRAN HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 50MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A210944-004MILNACIPRAN HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDTABLETORALMILNACIPRAN HYDROCHLORIDE: 100MG2026/09/15N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N022256-001SAVELLAABBVIE INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 12.5MG2009/01/14Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N022256-002SAVELLAABBVIE INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 25MG2009/01/14Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N022256-003SAVELLAABBVIE INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 50MG2009/01/14Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N022256-004SAVELLAABBVIE INCTABLETORALMILNACIPRAN HYDROCHLORIDE: 100MG2009/01/14Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗

Listed US patents

*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.

Latest listed patent expiration2029/09/19
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 numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
N022256-00179942202029/09/19— / —U-819—openFDA ↗
N022256-00279942202029/09/19— / —U-819—openFDA ↗
N022256-00379942202029/09/19— / —U-819—openFDA ↗
N022256-00479942202029/09/19— / —U-819—openFDA ↗

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: —

Application / product numberExclusivity codeListed expirationOfficial 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 dateOfficial source
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2024715850mg2024/07/10Official source ↗
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H2024355225mg2024/04/24Official source ↗
Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized国药准字H2023451025mg2023/11/21Official source ↗
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2010005225mg2022/05/18Official source ↗
Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized国药准字H2026920050mg2026/08/11Official source ↗

NHSA approval numbers 4

Company (original)Identifier (original)Source dateOfficial source
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2010005225mg—Official source ↗
Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized国药准字H2023451025mg—Official source ↗
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H2024355225mg—Official source ↗
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2010005225mg—Official source ↗
Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized国药准字H2023451025mg—Official source ↗
Hebei Long Hai Pharma Co., Ltd. romanized国药准字H2024355225mg—Official source ↗
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2010005225mg—Official source ↗
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2024715850mg—Official source ↗
Shanghai Shyndec Pharmaceutical Co., Ltd.国药准字H2024715850mg—Official source ↗

Under review 8

Company (original)Identifier (original)Source dateOfficial source
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.CYHS26023292026/09/18Official source ↗
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.CYHS26023282026/09/18Official source ↗
Hebei Wan Long Pharma Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanizedCYHS26011972026/05/26Official source ↗
Hebei Wan Long Pharma Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanizedCYHS26011962026/05/26Official source ↗
Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedCYHS26008582026/04/14Official source ↗
Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedCYHS26008572026/04/14Official source ↗
Zhejiang Hua Bei Pharma Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanizedCYHS26005862026/02/28Official source ↗
Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanizedCYHS25031732025/08/29Official source ↗

Generic-filing companies this year 4

Company (original)Identifier (original)Source dateOfficial source
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.CYHS26023292026/09/18Official source ↗
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.CYHS26023282026/09/18Official source ↗
Hebei Wan Long Pharma Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanizedCYHS26011972026/05/26Official source ↗
Hebei Wan Long Pharma Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanizedCYHS26011962026/05/26Official source ↗
Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedCYHS26008582026/04/14Official source ↗
Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedCYHS26008572026/04/14Official source ↗
Zhejiang Hua Bei Pharma Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanizedCYHS26005862026/02/28Official source ↗

API companies with A status 5

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Wei Qi Da Pharma Co., Ltd. romanizedY202400010962026/02/13Official source ↗
Lu Zhou Ke Rui De Pharmaceutical Co., Ltd. romanizedY202100008292026/06/10Official source ↗
Hetero Labs LimitedY201900007792025/09/30Official source ↗
Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanizedY201900215862026/07/29Official source ↗
Shanghai Shyndec Pharmaceutical Co., Ltd.Y20190002147—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