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Vardenafil Hydrochloride Orally disintegrating Tablets

Matched
Active ingredients (original)
VARDENAFIL HYDROCHLORIDE
Dosage form (original)
TABLET, ORALLY DISINTEGRATING
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 approval2010/06/17
ANDA applications2
RLD applicantBAYER HEALTHCARE PHARMACEUTICALS INC

Currently marketed products: 2 · 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
A205988-001VARDENAFIL HYDROCHLORIDEMACLEODS PHARMACEUTICALS LTDTABLET, ORALLY DISINTEGRATINGORALVARDENAFIL HYDROCHLORIDE: 10MG2020/03/10N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208324-001VARDENAFIL HYDROCHLORIDEALEMBIC PHARMACEUTICALS LTDTABLET, ORALLY DISINTEGRATINGORALVARDENAFIL HYDROCHLORIDE: 10MG2018/11/16N / YHUMAN PRESCRIPTION DRUGopenFDA ↗
N200179-001STAXYNBAYER HEALTHCARE PHARMACEUTICALS INCTABLET, ORALLY DISINTEGRATINGORALVARDENAFIL HYDROCHLORIDE: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**2010/06/17Y / NDISCONTINUEDopenFDA ↗

Listed US patents

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

Latest listed patent expiration2028/12/23
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
N200179-00186139502028/12/23— / Y——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 4

Company (original)Identifier (original)Source dateOfficial source
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20264808See source2026/06/17Official source ↗
Jiangxi Shimei Pharmaceutical Co., Ltd国药准字H20264594See source2026/06/03Official source ↗
Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H20263945See source2026/04/14Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20253822See source2025/04/08Official source ↗

NHSA approval numbers 5

Company (original)Identifier (original)Source dateOfficial source
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.国药准字H20264808See source—Official source ↗
Jiangxi Shimei Pharmaceutical Co., Ltd国药准字H20264594See source—Official source ↗
Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H20263945See source—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20253822See source—Official source ↗
GMep Medical Technology GmbH国药准字HJ20250089See source—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20253822See source—Official source ↗
GMep Medical Technology GmbH国药准字HJ20250089See source—Official source ↗
GMep Medical Technology GmbH国药准字HJ20250089See source—Official source ↗
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20253822See source—Official source ↗

Under review 4

Company (original)Identifier (original)Source dateOfficial source
Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanizedCYHS25030512025/08/20Official source ↗
Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS26022612026/09/10Official source ↗
Jiangxi Hui Ren Pharma Co., Ltd. romanizedCYHS26015842026/07/03Official source ↗
Anhui Sheng Ying Pharma Co., Ltd. romanizedCYHS26009582026/04/24Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS26022612026/09/10Official source ↗
Jiangxi Hui Ren Pharma Co., Ltd. romanizedCYHS26015842026/07/03Official source ↗
Anhui Sheng Ying Pharma Co., Ltd. romanizedCYHS26009582026/04/24Official source ↗

API companies with A status 9

Company (original)Identifier (original)Source dateOfficial source
Shanghai He Quan Pharma Co., Ltd. romanizedY202300011582025/07/29Official source ↗
Yang Ling Ji Tai Pharma Co., Ltd. romanizedY202300000212024/10/17Official source ↗
Alembic Pharmaceuticals LimitedY202100000752024/06/28Official source ↗
Changzhou Pharmaceutical Factory Co., Ltd. romanizedY202100007462023/09/27Official source ↗
Guangxi Qiang Shou Pharma Group Co., Ltd. romanizedY202100005002024/01/17Official source ↗
Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY202100000362025/01/11Official source ↗
Jin Hong Pharma Co., Ltd., Jin Hong Pharma Co., Ltd. romanizedY202000010952024/04/19Official source ↗
Shandong Lang Nuo Pharmaceutical Co., Ltd. romanizedY201800015282024/02/07Official source ↗
Sichuan Kelun Pharmaceutical Co., Ltd.Y201800007522025/04/23Official 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