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Dexmethylphenidate Hydrochloride Tablets

Matched
Active ingredients (original)
DEXMETHYLPHENIDATE 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 approval2001/11/13
ANDA applications10
RLD applicantSANDOZ INC

Currently marketed products: 20 · 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
A077107-001DEXMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMACEUTICALS USATABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2007/01/29N / NDISCONTINUEDopenFDA ↗
A077107-002DEXMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMACEUTICALS USATABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2007/01/29N / NDISCONTINUEDopenFDA ↗
A077107-003DEXMETHYLPHENIDATE HYDROCHLORIDETEVA PHARMACEUTICALS USATABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2007/01/29N / NDISCONTINUEDopenFDA ↗
A201231-001DEXMETHYLPHENIDATE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2015/09/24N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A201231-002DEXMETHYLPHENIDATE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2015/09/24N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A201231-003DEXMETHYLPHENIDATE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2015/09/24N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204534-001DEXMETHYLPHENIDATE HYDROCHLORIDENOVEL LABORATORIES INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2015/12/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204534-002DEXMETHYLPHENIDATE HYDROCHLORIDENOVEL LABORATORIES INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2015/12/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A204534-003DEXMETHYLPHENIDATE HYDROCHLORIDENOVEL LABORATORIES INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2015/12/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A206931-001DEXMETHYLPHENIDATE HYDROCHLORIDEABHAI LLCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2015/12/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A206931-002DEXMETHYLPHENIDATE HYDROCHLORIDEABHAI LLCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2015/12/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A206931-003DEXMETHYLPHENIDATE HYDROCHLORIDEABHAI LLCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2015/12/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207901-001DEXMETHYLPHENIDATE HYDROCHLORIDETRIS PHARMA INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2016/08/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207901-002DEXMETHYLPHENIDATE HYDROCHLORIDETRIS PHARMA INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2016/08/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A207901-003DEXMETHYLPHENIDATE HYDROCHLORIDETRIS PHARMA INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2016/08/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A208756-001DEXMETHYLPHENIDATE HYDROCHLORIDERHODES PHARMACEUTICALS LPTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2017/11/20N / NDISCONTINUEDopenFDA ↗
A208756-002DEXMETHYLPHENIDATE HYDROCHLORIDERHODES PHARMACEUTICALS LPTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2017/11/20N / NDISCONTINUEDopenFDA ↗
A208756-003DEXMETHYLPHENIDATE HYDROCHLORIDERHODES PHARMACEUTICALS LPTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2017/11/20N / NDISCONTINUEDopenFDA ↗
A209211-001DEXMETHYLPHENIDATE HYDROCHLORIDECEDIPROF INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2018/09/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A209211-002DEXMETHYLPHENIDATE HYDROCHLORIDECEDIPROF INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2018/09/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A209468-001DEXMETHYLPHENIDATE HYDROCHLORIDELANNETT CO INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2017/09/25N / NDISCONTINUEDopenFDA ↗
A209468-002DEXMETHYLPHENIDATE HYDROCHLORIDELANNETT CO INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2017/09/25N / NDISCONTINUEDopenFDA ↗
A209468-003DEXMETHYLPHENIDATE HYDROCHLORIDELANNETT CO INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2017/09/25N / NDISCONTINUEDopenFDA ↗
A209754-001DEXMETHYLPHENIDATE HYDROCHLORIDEBIONPHARMA INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2020/03/24N / NDISCONTINUEDopenFDA ↗
A209754-002DEXMETHYLPHENIDATE HYDROCHLORIDEBIONPHARMA INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2020/03/24N / NDISCONTINUEDopenFDA ↗
A212631-001DEXMETHYLPHENIDATE HYDROCHLORIDEALKEM LABORATORIES LTDTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2019/07/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212631-002DEXMETHYLPHENIDATE HYDROCHLORIDEALKEM LABORATORIES LTDTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2019/07/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212631-003DEXMETHYLPHENIDATE HYDROCHLORIDEALKEM LABORATORIES LTDTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2019/07/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N021278-001FOCALINSANDOZ INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 2.5MG2001/11/13Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N021278-002FOCALINSANDOZ INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 5MG2001/11/13Y / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N021278-003FOCALINSANDOZ INCTABLETORALDEXMETHYLPHENIDATE HYDROCHLORIDE: 10MG2001/11/13Y / 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 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 numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
Not listed

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 0

Company (original)Identifier (original)Source dateOfficial source
No matching records in this loaded source.

NHSA approval numbers 0

Company (original)Identifier (original)Source dateOfficial source
No matching records in this loaded source.

Under review 1

Company (original)Identifier (original)Source dateOfficial source
Guo Yao Group Guo Rui Pharma Co., Ltd. romanizedCYHL26000952026/09/04Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Guo Yao Group Guo Rui Pharma Co., Ltd. romanizedCYHL26000952026/09/04Official source ↗
Henan Zhong Shuai Pharma Co., Ltd. romanizedCYHL26000702026/06/09Official source ↗

API companies with A status 2

Company (original)Identifier (original)Source dateOfficial source
Hefei Li Fang Pharmaceutical Co., Ltd. romanizedY202400013402026/09/20Official source ↗
Henan Zhong Shuai Pharma Co., Ltd. romanizedY202000013102025/02/07Official 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 TABLET / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-001. Chinese Pharmacopoeia general chapter 0101

Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗

Name and dosage-form matching sources