OSELTAMIVIR PHOSPHATE - Generic Drug Details
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What are the generic sources for oseltamivir phosphate and what is the scope of patent protection?
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, Lupin, Macleods Pharms Ltd, MSN, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Roche, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aptapharma Inc, Chemistry Hlth, Hetero Labs Ltd V, and Teva Pharms Usa, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for oseltamivir phosphate. Thirty-two suppliers are listed for this compound.
Summary for OSELTAMIVIR PHOSPHATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 23 |
NDAs: | 30 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 32 |
Raw Ingredient (Bulk) Api Vendors: | 96 |
Clinical Trials: | 24 |
Patent Applications: | 5,003 |
Formulation / Manufacturing: | see details |
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 |
---|---|
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
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
Expired US Patents for OSELTAMIVIR PHOSPHATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-003 | Jul 2, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | TAMIFLU | oseltamivir phosphate | FOR SUSPENSION;ORAL | 021246-001 | Dec 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-002 | Jul 2, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-003 | Jul 2, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | TAMIFLU | oseltamivir phosphate | CAPSULE;ORAL | 021087-001 | Oct 27, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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