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Sign in to subscribePregabalin Extended release Tablets
Matched- Active ingredients (original)
- PREGABALIN
- 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 approval2017/10/11
ANDA applications13
RLD applicantUPJOHN US 2 LLC
Currently marketed products: 14 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A211431-001 | PREGABALIN | PHARMOBEDIENT CONSULTING LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2021/07/02 | N / N | DISCONTINUED | openFDA ↗ |
| A211593-001 | PREGABALIN | ALVOGEN INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211593-002 | PREGABALIN | ALVOGEN INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211593-003 | PREGABALIN | ALVOGEN INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211687-001 | PREGABALIN | ALVOGEN MALTA OPERATIONS LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2021/07/06 | N / N | DISCONTINUED | openFDA ↗ |
| A211687-002 | PREGABALIN | ALVOGEN MALTA OPERATIONS LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2021/07/06 | N / N | DISCONTINUED | openFDA ↗ |
| A211687-003 | PREGABALIN | ALVOGEN MALTA OPERATIONS LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2021/07/06 | N / N | DISCONTINUED | openFDA ↗ |
| A211889-001 | PREGABALIN | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211889-002 | PREGABALIN | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211889-003 | PREGABALIN | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211948-001 | PREGABALIN | PHARMOBEDIENT CONSULTING LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A211967-001 | PREGABALIN | PHARMOBEDIENT CONSULTING LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2021/11/04 | N / N | DISCONTINUED | openFDA ↗ |
| A213226-001 | PREGABALIN | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2021/04/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213226-002 | PREGABALIN | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2021/04/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213226-003 | PREGABALIN | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2021/04/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213313-001 | PREGABALIN | APOTEX INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A213313-002 | PREGABALIN | APOTEX INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2021/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A214496-001 | PREGABALIN | EPIC PHARMA LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2023/06/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214496-002 | PREGABALIN | EPIC PHARMA LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2023/06/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214496-003 | PREGABALIN | EPIC PHARMA LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2023/06/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215249-001 | PREGABALIN | RUBICON RESEARCH LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2022/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215249-002 | PREGABALIN | RUBICON RESEARCH LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2022/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215249-003 | PREGABALIN | RUBICON RESEARCH LTD | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2022/03/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215577-001 | PREGABALIN | ZYDUS PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2022/08/26 | N / N | DISCONTINUED | openFDA ↗ |
| A215577-002 | PREGABALIN | ZYDUS PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2022/08/26 | N / N | DISCONTINUED | openFDA ↗ |
| A215577-003 | PREGABALIN | ZYDUS PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2022/08/26 | N / N | DISCONTINUED | openFDA ↗ |
| A215675-001 | PREGABALIN | SCIEGEN PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2022/09/14 | N / N | DISCONTINUED | openFDA ↗ |
| A215675-002 | PREGABALIN | SCIEGEN PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2022/09/14 | N / N | DISCONTINUED | openFDA ↗ |
| A215675-003 | PREGABALIN | SCIEGEN PHARMACEUTICALS INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2022/09/14 | N / N | DISCONTINUED | openFDA ↗ |
| A217857-001 | PREGABALIN | AIPING PHARMACEUTICAL INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2025/01/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217857-002 | PREGABALIN | AIPING PHARMACEUTICAL INC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2026/06/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N209501-001 | LYRICA CR | UPJOHN US 2 LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 82.5MG | 2017/10/11 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N209501-002 | LYRICA CR | UPJOHN US 2 LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 165MG | 2017/10/11 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N209501-003 | LYRICA CR | UPJOHN US 2 LLC | TABLET, EXTENDED RELEASE | ORAL | PREGABALIN: 330MG | 2017/10/11 | Y / Y | 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 expiration2027/05/02This latest date comes from a *PED row in the source and is displayed as listed.
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 |
|---|---|---|---|---|---|---|
| N209501-001 | 10022447 | 2026/11/02 | — / — | U-2136 | — | openFDA ↗ |
| N209501-001 | 10022447*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-001 | 8945620 | 2026/11/02 | — / Y | U-2137 | — | openFDA ↗ |
| N209501-001 | 8945620*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-001 | 9144559 | 2026/11/02 | — / Y | — | — | openFDA ↗ |
| N209501-001 | 9144559*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-002 | 10022447 | 2026/11/02 | — / — | U-2136 | — | openFDA ↗ |
| N209501-002 | 10022447*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-002 | 8945620 | 2026/11/02 | — / Y | U-2136 | — | openFDA ↗ |
| N209501-002 | 8945620*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-002 | 9144559 | 2026/11/02 | — / Y | — | — | openFDA ↗ |
| N209501-002 | 9144559*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-003 | 10022447 | 2026/11/02 | — / — | U-2136 | — | openFDA ↗ |
| N209501-003 | 10022447*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-003 | 8945620 | 2026/11/02 | — / Y | U-2136 | — | openFDA ↗ |
| N209501-003 | 8945620*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
| N209501-003 | 9144559 | 2026/11/02 | — / Y | — | — | openFDA ↗ |
| N209501-003 | 9144559*PED | 2027/05/02 | — / — | — | — | openFDA ↗ |
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 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2021004182.5mg | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2021004182.5mg | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20210042165mg | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20210042165mg | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20210043330mg | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H20210043330mg | — | Official source ↗ |
Under review 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602149 | 2026/08/27 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602148 | 2026/08/27 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602147 | 2026/08/27 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602018 | 2026/08/14 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602017 | 2026/08/14 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602016 | 2026/08/14 | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | CYHS2601907 | 2026/08/05 | Official source ↗ |
| Beijing Tai De Pharmaceutical Co., Ltd. romanized | CYHS2601329 | 2026/06/08 | Official source ↗ |
| Beijing Tai De Pharmaceutical Co., Ltd. romanized | CYHS2601328 | 2026/06/08 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2502317 | 2025/06/28 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2502316 | 2025/06/28 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2502315 | 2025/06/28 | Official source ↗ |
| Chongqing De Run Sheng Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2602684 | 2026/11/03 | Official source ↗ |
Generic-filing companies this year 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602149 | 2026/08/27 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602148 | 2026/08/27 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602147 | 2026/08/27 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602018 | 2026/08/14 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602017 | 2026/08/14 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2602016 | 2026/08/14 | Official source ↗ |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | CYHS2601907 | 2026/08/05 | Official source ↗ |
| Beijing Tai De Pharmaceutical Co., Ltd. romanized | CYHS2601329 | 2026/06/08 | Official source ↗ |
| Beijing Tai De Pharmaceutical Co., Ltd. romanized | CYHS2601328 | 2026/06/08 | Official source ↗ |
| Chongqing De Run Sheng Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2602684 | 2026/11/03 | Official source ↗ |
API companies with A status 25
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| MSN Pharmachem Private Limited | Y20240000210 | 2026/05/20 | Official source ↗ |
| Upjohn EESV | Y20230001164 | 2025/12/29 | Official source ↗ |
| Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20230000632 | 2025/04/07 | Official source ↗ |
| Hikal Limited | Y20220000761 | 2025/04/22 | Official source ↗ |
| Hunan Sai Long Pharma Co., Ltd. romanized | Y20210000955 | 2024/03/07 | Official source ↗ |
| Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20210000638 | 2024/01/24 | Official source ↗ |
| MSN Life Sciences Private Limited Unit - III romanized | Y20200001043 | 2025/08/16 | Official source ↗ |
| Divi’s Laboratories Limited | Y20210000256 | 2024/01/17 | Official source ↗ |
| DR. REDDYS LABORATORIES LIMITED | Y20200000823 | 2026/07/11 | Official source ↗ |
| Jiangsu Hui Ju Pharma Co., Ltd. romanized | Y20190000654 | 2026/04/24 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190021404 | 2026/03/17 | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20190021315 | 2026/04/20 | Official source ↗ |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | Y20190009848 | — | Official source ↗ |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | Y20190000198 | 2025/09/25 | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | Y20190000368 | 2026/08/14 | Official source ↗ |
| Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20180001381 | 2026/01/13 | Official source ↗ |
| Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20180001513 | 2025/07/18 | Official source ↗ |
| Jiangsu En Hua Pharma Co., Ltd. romanized | Y20170001560 | 2023/07/14 | Official source ↗ |
| Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20170001559 | 2023/05/11 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20170001497 | 2023/08/16 | Official source ↗ |
| Guo Yao Group Yi Bin Pharmaceutical Co., Ltd. romanized | Y20170001200 | 2024/04/26 | Official source ↗ |
| Hetero Drugs Limited, Unit- IX | Y20170001183 | 2025/12/06 | Official source ↗ |
| Lang Fang Gao Bo Jing Bang Pharmaceutical Co., Ltd. romanized | Y20170001167 | 2022/09/08 | Official source ↗ |
| SUN PHARMACEUTICAL INDUSTRIES LTD | Y20170000832 | 2022/09/05 | Official source ↗ |
| Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20170000821 | 2026/10/30 | Official source ↗ |
| Alembic Pharmaceuticals Ltd. | Y20170000779 | 2026/03/19 | Official source ↗ |
| CTX Lifesciences Pvt. Ltd. | Y20170000558 | 2026/08/22 | 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 ↗ · 26-179 · 2019/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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