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Dronedarone Hydrochloride Tablets

Matched
Active ingredients (original)
DRONEDARONE 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 approval2009/07/01
ANDA applications1
RLD applicantSANOFI AVENTIS US LLC

Currently marketed products: 1 · 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
A205904-001DRONEDARONE HYDROCHLORIDELUPIN INCTABLETORALDRONEDARONE HYDROCHLORIDE: EQ 400MG BASE2024/01/31N / NDISCONTINUEDopenFDA ↗
N022425-001MULTAQSANOFI AVENTIS US LLCTABLETORALDRONEDARONE HYDROCHLORIDE: EQ 400MG BASE2009/07/01Y / YHUMAN 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 expiration2031/06/30
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
N022425-00184101672029/04/16— / —U-1387—openFDA ↗
N022425-00186022152031/06/30— / —U-1473—openFDA ↗
N022425-00191079002029/04/16— / —U-1726—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 8

Company (original)Identifier (original)Source dateOfficial source
Qilu Pharmaceutical Co., Ltd.国药准字H20254815See source2025/07/08Official source ↗
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20254075See source2025/05/13Official source ↗
Jiangxi Ke Rui Pharma Co., Ltd. romanized国药准字H20253890See source2025/04/15Official source ↗
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H20253735See source2025/03/25Official source ↗
Jiangsu Li Tai Er Pharma Co., Ltd. romanized国药准字H20243515See source2024/04/17Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20193291See source2022/11/10Official source ↗
Sanofi-Aventis U.S., LLC国药准字HJ20210084See source2021/12/20Official source ↗
Anhui Ai Li De Pharmaceutical Co., Ltd. romanized国药准字H20264701See source2026/06/10Official source ↗

NHSA approval numbers 7

Company (original)Identifier (original)Source dateOfficial source
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H20254075See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20193291See source—Official source ↗
Qilu Pharmaceutical Co., Ltd.国药准字H20254815See source—Official source ↗
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H20253735See source—Official source ↗
Jiangsu Li Tai Er Pharma Co., Ltd. romanized国药准字H20243515See source—Official source ↗
Sanofi Aventis U.S., LLC国药准字HJ20210084See source—Official source ↗
Jiangxi Ke Rui Pharma Co., Ltd. romanized国药准字H20253890See source—Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H20193291See source—Official source ↗
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H20253735See source—Official source ↗
Sanofi Aventis U.S., LLC国药准字HJ20210084See source—Official source ↗
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H20253735See source—Official source ↗
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H20253735See source—Official source ↗

Under review 4

Company (original)Identifier (original)Source dateOfficial source
Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized; Chengdu Di Yi Pharmaceutical Co., Ltd. romanizedCYHS26023412026/09/20Official source ↗
Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanizedCYHS26000362026/01/06Official source ↗
Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanizedCYHS26025852026/10/21Official source ↗
Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Huang Hai Pharmaceutical Co., Ltd. romanizedCYHS25036372025/10/12Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized; Chengdu Di Yi Pharmaceutical Co., Ltd. romanizedCYHS26023412026/09/20Official source ↗
Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanizedCYHS26000362026/01/06Official source ↗
Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanizedCYHS26025852026/10/21Official source ↗

API companies with A status 6

Company (original)Identifier (original)Source dateOfficial source
Anhui Ai Li De Pharmaceutical Co., Ltd. romanizedY202400012852026/07/16Official source ↗
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedY202400006782026/03/16Official source ↗
Hebei Guo Long Pharmaceutical Co., Ltd. romanizedY202300007332026/02/28Official source ↗
Aurore Pharmaceuticals Private LimitedY202200009342026/06/09Official source ↗
Jiangsu Hui Ju Pharma Co., Ltd. romanizedY202200002972025/09/26Official source ↗
CSPC OUYI PHARMACEUTICAL CO., LTD.Y201700012722026/03/11Official 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