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Sign in to subscribeDolutegravir Sodium Tablets
Matched- Active ingredients (original)
- DOLUTEGRAVIR SODIUM
- Dosage form (original)
- TABLET
- 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 approval2013/08/12
ANDA applications0
RLD applicantVIIV HEALTHCARE CO
Currently marketed products: 1 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| N204790-001 | TIVICAY | VIIV HEALTHCARE CO | TABLET | ORAL | DOLUTEGRAVIR SODIUM: EQ 50MG BASE | 2013/08/12 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N204790-002 | TIVICAY | VIIV HEALTHCARE CO | TABLET | ORAL | DOLUTEGRAVIR SODIUM: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2016/06/09 | Y / N | DISCONTINUED | openFDA ↗ |
| N204790-003 | TIVICAY | VIIV HEALTHCARE CO | TABLET | ORAL | DOLUTEGRAVIR SODIUM: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2016/06/09 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration2030/06/08This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2029/12/08
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 |
|---|---|---|---|---|---|---|
| N204790-001 | 8129385 | 2027/10/05 | Y / Y | — | — | openFDA ↗ |
| N204790-001 | 8129385*PED | 2028/04/05 | — / — | — | — | openFDA ↗ |
| N204790-001 | 9242986 | 2029/12/08 | Y / Y | — | — | openFDA ↗ |
| N204790-001 | 9242986*PED | 2030/06/08 | — / — | — | — | openFDA ↗ |
| N204790-002 | 8129385 | 2027/10/05 | Y / Y | — | — | openFDA ↗ |
| N204790-002 | 8129385*PED | 2028/04/05 | — / — | — | — | openFDA ↗ |
| N204790-002 | 9242986 | 2029/12/08 | Y / Y | — | — | openFDA ↗ |
| N204790-002 | 9242986*PED | 2030/06/08 | — / — | — | — | openFDA ↗ |
| N204790-003 | 8129385 | 2027/10/05 | Y / Y | — | — | openFDA ↗ |
| N204790-003 | 8129385*PED | 2028/04/05 | — / — | — | — | openFDA ↗ |
| N204790-003 | 9242986 | 2029/12/08 | Y / Y | — | — | openFDA ↗ |
| N204790-003 | 9242986*PED | 2030/06/08 | — / — | — | — | 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 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20264225See source | 2026/05/07 | Official source ↗ |
| Jiangsu Ai Di Pharma Group Co., Ltd. romanized | 国药准字H20263536See source | 2026/03/10 | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ20260023See source | 2026/02/10 | Official source ↗ |
| Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20255617See source | 2025/09/30 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20234126See source | 2023/09/05 | Official source ↗ |
| Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized | 国药准字H20266322See source | 2026/10/20 | Official source ↗ |
NHSA approval numbers 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20234126See source | — | Official source ↗ |
| Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20255617See source | — | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20264225See source | — | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ20260023See source | — | Official source ↗ |
| ViiV Healthcare UK Limited | H20150683See source | — | Official source ↗ |
| Jiangsu Ai Di Pharma Group Co., Ltd. romanized | 国药准字H20263536See source | — | Official source ↗ |
| ViiV Healthcare B.V. | 国药准字HJ20150683See source | — | Official source ↗ |
Under review 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | CYHS2602412 | 2026/09/24 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601019 | 2026/04/30 | Official source ↗ |
| ViiV Healthcare B.V.; Delpharm Poznan S.A | JYHB2500595 | 2025/11/06 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | CYHS2602412 | 2026/09/24 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2601019 | 2026/04/30 | Official source ↗ |
API companies with A status 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20250000207 | 2026/07/27 | Official source ↗ |
| Anhui Bei Ke Pharmaceutical Co., Ltd. romanized | Y20240001543 | 2026/07/02 | Official source ↗ |
| Chongqing Kai Lin Pharmaceutical Co., Ltd. romanized | Y20240000649 | 2026/03/20 | Official source ↗ |
| Chongqing Bo Teng Pharmaceutical Technology Co., Ltd. romanized | Y20240000525 | 2026/02/13 | Official source ↗ |
| Yang Zhou Ai Di Pharmaceuticals Technology Co., Ltd. romanized | Y20240000542 | 2025/10/27 | Official source ↗ |
| Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20240000231 | 2025/09/17 | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20240000162 | 2025/11/14 | Official source ↗ |
| Yang Zhou Ao Rui Te Pharma Co., Ltd. romanized | Y20230001397 | 2026/05/15 | Official source ↗ |
| Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20220000041 | 2023/09/14 | 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.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 31-3 · 2020/11/20
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