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, Aptapharma Inc, 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: | 26 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd Iii | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 209438-001 | Feb 23, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hetero Labs Ltd Iii | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 209438-003 | Feb 23, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Natco | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 202595-002 | Aug 3, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | OSELTAMIVIR PHOSPHATE | oseltamivir phosphate | CAPSULE;ORAL | 210157-003 | Jan 21, 2021 | DISCN | 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 | |||
>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 | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | ⤷ 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 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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