Oseltamivir phosphate - Generic Drug Details
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What are the generic sources for oseltamivir phosphate and what is the scope of freedom to operate?
Oseltamivir phosphate
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alembic, Amneal Pharms, Epic Pharma Llc, Hainan Poly, Hetero Labs Ltd Iii, Invagen Pharms, Laurus, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Roche, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Leading, Oryza, and Teva Pharms Usa, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for oseltamivir phosphate. Thirty-five suppliers are listed for this compound.
Summary for oseltamivir phosphate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 25 |
| NDAs: | 33 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 35 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Clinical Trials: | 25 |
| Patent Applications: | 4,801 |
| What excipients (inactive ingredients) are in oseltamivir phosphate? | oseltamivir phosphate excipients list |
| DailyMed Link: | oseltamivir phosphate at DailyMed |
Recent Clinical Trials for oseltamivir phosphate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nanjing Zenshine Pharmaceuticals | Phase 1 |
| Laboratorios Andromaco S.A. | Phase 1 |
| Sunshine Lake Pharma Co., Ltd. | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Natco | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 202595-002 | Aug 3, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Leading | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 214949-001 | Feb 28, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hainan Poly | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 218009-001 | Nov 24, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | FOR SUSPENSION;ORAL | 211125-001 | Feb 27, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 208348-001 | Jan 9, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 209421-003 | Jun 8, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Epic Pharma Llc | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 215208-003 | Oct 1, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for oseltamivir phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-002 | Mar 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-003 | Jul 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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