Monthly
US$200
Billed every month
Sign in to subscribeZolpidem tartrate extended-release tablets
Matched- Active ingredients (original)
- ZOLPIDEM TARTRATE
- Dosage form (original)
- TABLET, EXTENDED RELEASE
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “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.
- This page contains no sales or market-size data and cannot establish development value.
- 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 approval2005/09/02
ANDA applications9
RLD applicantCOSETTE PHARMACEUTICALS INC
Currently marketed products: 10 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A078148-001 | ZOLPIDEM TARTRATE | PH HEALTH LTD | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2010/12/03 | N / N | DISCONTINUED | openFDA ↗ |
| A078148-002 | ZOLPIDEM TARTRATE | PH HEALTH LTD | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2011/04/14 | N / N | DISCONTINUED | openFDA ↗ |
| A078179-001 | ZOLPIDEM TARTRATE | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2011/06/06 | N / N | DISCONTINUED | openFDA ↗ |
| A078179-002 | ZOLPIDEM TARTRATE | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2010/10/13 | N / N | DISCONTINUED | openFDA ↗ |
| A078483-001 | ZOLPIDEM TARTRATE | SYNTHON PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2011/04/12 | N / N | DISCONTINUED | openFDA ↗ |
| A078483-002 | ZOLPIDEM TARTRATE | SYNTHON PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2011/06/06 | N / N | DISCONTINUED | openFDA ↗ |
| A078970-001 | ZOLPIDEM TARTRATE | LUPIN LTD | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2013/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078970-002 | ZOLPIDEM TARTRATE | LUPIN LTD | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2013/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090107-001 | ZOLPIDEM TARTRATE | SANDOZ INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2011/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090107-002 | ZOLPIDEM TARTRATE | SANDOZ INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2011/07/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090153-001 | ZOLPIDEM TARTRATE | ACTAVIS LABORATORIES FL INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2013/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A090153-002 | ZOLPIDEM TARTRATE | ACTAVIS LABORATORIES FL INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2013/03/25 | N / N | DISCONTINUED | openFDA ↗ |
| A200266-001 | ZOLPIDEM TARTRATE | APOTEX INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2013/09/10 | N / N | DISCONTINUED | openFDA ↗ |
| A200266-002 | ZOLPIDEM TARTRATE | APOTEX INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2013/09/10 | N / N | DISCONTINUED | openFDA ↗ |
| A204170-001 | ZOLPIDEM TARTRATE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2017/01/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204170-002 | ZOLPIDEM TARTRATE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2017/01/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213592-001 | ZOLPIDEM TARTRATE | BRECKENRIDGE PHARMACEUTICAL INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2020/06/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213592-002 | ZOLPIDEM TARTRATE | BRECKENRIDGE PHARMACEUTICAL INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2020/06/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021774-001 | AMBIEN CR | COSETTE PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 12.5MG | 2005/09/02 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021774-002 | AMBIEN CR | COSETTE PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | ZOLPIDEM TARTRATE: 6.25MG | 2005/09/02 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
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 number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official 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 date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHL2600119 | 2026/10/21 | Official source ↗ |
| Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHL2600118 | 2026/10/21 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHL2600117 | 2026/10/14 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHL2600116 | 2026/10/14 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHL2600119 | 2026/10/21 | Official source ↗ |
| Xian Yuan Da De Tian Pharma Co., Ltd. romanized | CYHL2600118 | 2026/10/21 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHL2600117 | 2026/10/14 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHL2600116 | 2026/10/14 | Official source ↗ |
API companies with A status 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Aarti Drugs Limited | Y20200001173 | 2025/01/26 | Official source ↗ |
| Hunan Ya Da Pharmaceutical Co., Ltd. romanized | Y20190006581 | — | Official source ↗ |
| Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | Y20190003530 | 2025/05/21 | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | Y20190002173 | 2025/08/22 | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Y20190001504 | 2025/03/21 | 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.
Formulation crosswalk to TABLET, EXTENDED RELEASE / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-003. Chinese Pharmacopoeia general chapter 0101
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 22-360 · 2019/08/28
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy