FDA Orange Book · active-ingredient family
Oseltamivir phosphate
Oseltamivir phosphate is approved as 2 brand and 36 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TAMIFLU · NDA 021246
2
Brand (NDA)
36
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAMIFLURLD×2 | ROCHE | NDA 021246 | AB | Mar 21, 2011 | |
| TAMIFLURLD×3 | ROCHE | NDA 021087 | — | Jul 02, 2007 |
Generic (ANDA) products (36)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE×3 | UPSHER SMITH LABS | ANDA 213437 | — | Jan 22, 2026 | |
| OSELTAMIVIR PHOSPHATE×3 | ZHEJIANG POLY PHARM | ANDA 218009 | AB | Oct 02, 2025 | |
| OSELTAMIVIR PHOSPHATE×3 | SHANDONG | ANDA 217274 | AB | Jul 09, 2025 | |
| OSELTAMIVIR PHOSPHATE | JUBILANT GENERICS | ANDA 213695 | AB | Mar 03, 2025 | |
| OSELTAMIVIR PHOSPHATE×3 | CEDIPROF INC | ANDA 217451 | — | Dec 03, 2024 | |
| OSELTAMIVIR PHOSPHATE×2 | BEIJING JIALIN | ANDA 217133 | AB | Oct 30, 2024 | |
| OSELTAMIVIR PHOSPHATE | PHARMOBEDIENT | ANDA 217303 | AB | Jul 02, 2024 | |
| OSELTAMIVIR PHOSPHATE | AUROBINDO PHARMA LTD | ANDA 218131 | AB | May 10, 2024 | |
| OSELTAMIVIR PHOSPHATE×3 | LAURUS | ANDA 218565 | AB | May 01, 2024 | |
| OSELTAMIVIR PHOSPHATE×3 | INVAGEN PHARMS | ANDA 217467 | AB | Oct 03, 2023 | |
| OSELTAMIVIR PHOSPHATE | EPIC PHARMA LLC | ANDA 215538 | AB | Feb 14, 2023 | |
| OSELTAMIVIR PHOSPHATE×3 | ACCORD HLTHCARE | ANDA 214726 | — | Jul 25, 2022 | |
| OSELTAMIVIR PHOSPHATE | MSN | ANDA 215313 | AB | May 02, 2022 | |
| OSELTAMIVIR PHOSPHATE | HETERO LABS LTD V | ANDA 209590 | AB | Mar 28, 2022 | |
| OSELTAMIVIR PHOSPHATE | LEADING | ANDA 214949 | — | Feb 28, 2022 | |
| OSELTAMIVIR PHOSPHATE | STRIDES PHARMA | ANDA 211894 | AB | Jan 13, 2022 | |
| OSELTAMIVIR PHOSPHATE | SUNSHINE | ANDA 213594 | AB | Jan 05, 2022 | |
| OSELTAMIVIR PHOSPHATE×3 | EPIC PHARMA LLC | ANDA 215208 | AB | Oct 01, 2021 | |
| OSELTAMIVIR PHOSPHATE | INVAGEN PHARMS | ANDA 212858 | AB | Aug 30, 2021 | |
| OSELTAMIVIR PHOSPHATE×3 | RISING | ANDA 210157 | — | Jan 21, 2021 | |
| OSELTAMIVIR PHOSPHATE | AJANTA PHARMA LTD | ANDA 212784 | AB | May 27, 2020 | |
| OSELTAMIVIR PHOSPHATE×3 | MSN | ANDA 212544 | AB | May 20, 2020 | |
| OSELTAMIVIR PHOSPHATE×3 | SUNSHINE | ANDA 212739 | AB | Mar 04, 2020 | |
| OSELTAMIVIR PHOSPHATE×3 | ALEMBIC | ANDA 211823 | AB | Jun 24, 2019 | |
| OSELTAMIVIR PHOSPHATE | TEVA PHARMS USA | ANDA 211125 | AB | Feb 27, 2019 | |
| OSELTAMIVIR PHOSPHATE×3 | STRIDES PHARMA | ANDA 209421 | AB | Jun 08, 2018 | |
| OSELTAMIVIR PHOSPHATE | AMNEAL PHARMS NY | ANDA 210186 | — | Feb 27, 2018 | |
| OSELTAMIVIR PHOSPHATE×3 | HETERO LABS LTD III | ANDA 209438 | AB | Feb 23, 2018 | |
| OSELTAMIVIR PHOSPHATE | LUPIN | ANDA 208347 | AB | Feb 20, 2018 | |
| OSELTAMIVIR PHOSPHATE×3 | LUPIN | ANDA 208348 | AB | Jan 09, 2018 | |
| OSELTAMIVIR PHOSPHATE | ALVOGEN | ANDA 208823 | AB | Oct 31, 2017 | |
| OSELTAMIVIR PHOSPHATE×3 | MACLEODS PHARMS LTD | ANDA 207211 | AB | Sep 14, 2017 | |
| OSELTAMIVIR PHOSPHATE | ZYDUS PHARMS | ANDA 209113 | AB | Sep 14, 2017 | |
| OSELTAMIVIR PHOSPHATE×3 | AMNEAL PHARMS | ANDA 209093 | AB | May 17, 2017 | |
| OSELTAMIVIR PHOSPHATE×3 | ZYDUS PHARMS | ANDA 208578 | AB | Feb 24, 2017 | |
| OSELTAMIVIR PHOSPHATE×3 | NATCO | ANDA 202595 | AB | Aug 03, 2016 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Oseltamivir phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
