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Ramelteon Tablets

Matched
Active ingredients (original)
RAMELTEON
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 approval2005/07/22
ANDA applications11
RLD applicantTAKEDA PHARMACEUTICALS USA INC

Currently marketed products: 11 · 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
A091610-001RAMELTEONACTAVIS LABORATORIES FL INCTABLETORALRAMELTEON: 8MG2015/08/19N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A091693-001RAMELTEONDR REDDYS LABORATORIES SATABLETORALRAMELTEON: 8MG2013/07/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A211567-001RAMELTEONZYDUS PHARMACEUTICALS USA INCTABLETORALRAMELTEON: 8MG2019/07/22N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A212650-001RAMELTEONPHARMAZONETABLETORALRAMELTEON: 8MG2020/04/10N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A213186-001RAMELTEONGRANULES PHARMACEUTICALS INCTABLETORALRAMELTEON: 8MG2020/08/21N / NDISCONTINUEDopenFDA ↗
A213815-001RAMELTEONAPPCO PHARMA LLCTABLETORALRAMELTEON: 8MG2020/10/26N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215243-001RAMELTEONMICRO LABS LTDTABLETORALRAMELTEON: 8MG2023/02/09N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215435-001RAMELTEONANDAS 5 HOLDING LLCTABLETORALRAMELTEON: 8MG2022/08/24N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215485-001RAMELTEONADAPTIS PHARMA PRIVATE LTDTABLETORALRAMELTEON: 8MG2026/06/04N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A215972-001RAMELTEONAUROBINDO PHARMA LTDTABLETORALRAMELTEON: 8MG2023/07/10N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A216209-001RAMELTEONXIROMED PHARMA ESPANA SLTABLETORALRAMELTEON: 8MG2022/11/25N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N021782-001ROZEREMTAKEDA PHARMACEUTICALS USA INCTABLETORALRAMELTEON: 8MG2005/07/22Y / 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
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.CYHS26001362026/01/10Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.CYHS26001362026/01/10Official source ↗
Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanizedCYHL26000162026/01/29Official source ↗
Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCYHL26000832026/07/23Official source ↗

API companies with A status 0

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