OSELTAMIVIR PHOSPHATE Drug Patent Profile
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Which patents cover Oseltamivir Phosphate, and when can generic versions of Oseltamivir Phosphate launch?
Oseltamivir Phosphate is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms, Epic Pharma Llc, Hainan Poly, Hetero Labs Ltd Iii, Invagen Pharms, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aptapharma Inc, Chemistry Hlth, Hetero Labs Ltd V, and Teva Pharms Usa. and is included in twenty-eight NDAs.
The generic ingredient in OSELTAMIVIR PHOSPHATE is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Oseltamivir Phosphate
A generic version of OSELTAMIVIR PHOSPHATE was approved as oseltamivir phosphate by NATCO on August 3rd, 2016.
Summary for OSELTAMIVIR PHOSPHATE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 28 |
| Finished Product Suppliers / Packagers: | 31 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Clinical Trials: | 24 |
| Patent Applications: | 3,104 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | OSELTAMIVIR PHOSPHATE at DailyMed |
Recent Clinical Trials for OSELTAMIVIR PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Andromaco S.A. | Phase 1 |
| Sunshine Lake Pharma Co., Ltd. | Phase 1 |
| The Affiliated Hospital of Qingdao University | Phase 1 |
Pharmacology for OSELTAMIVIR PHOSPHATE
| Drug Class | Neuraminidase Inhibitor |
| Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for OSELTAMIVIR PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for OSELTAMIVIR PHOSPHATE
Paragraph IV (Patent) Challenges for OSELTAMIVIR PHOSPHATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TAMIFLU | for Oral Suspension | oseltamivir phosphate | 6 mg/mL | 021246 | 1 | 2015-06-18 |
| TAMIFLU | Capsules | oseltamivir phosphate | 30 mg and 45 mg | 021087 | 1 | 2011-08-02 |
| TAMIFLU | Capsules | oseltamivir phosphate | 75 mg | 021087 | 1 | 2010-11-15 |
US Patents and Regulatory Information for OSELTAMIVIR PHOSPHATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 208578-001 | Feb 24, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rising | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 210157-001 | Jan 21, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Epic Pharma Llc | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 215538-001 | Feb 14, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
