Peramivir - Generic Drug Details
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What are the generic drug sources for peramivir and what is the scope of freedom to operate?
Peramivir
is the generic ingredient in one branded drug marketed by Biocryst and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Peramivir has sixty-seven patent family members in twenty-eight countries.
There is one drug master file entry for peramivir.
Summary for peramivir
| International Patents: | 67 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 15 |
| Patent Applications: | 2,923 |
| What excipients (inactive ingredients) are in peramivir? | peramivir excipients list |
| DailyMed Link: | peramivir at DailyMed |
Recent Clinical Trials for peramivir
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 3 |
| Department of Health and Human Services | Phase 4 |
| Johns Hopkins University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for peramivir
US Patents and Regulatory Information for peramivir
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biocryst | RAPIVAB | peramivir | SOLUTION;INTRAVENOUS | 206426-001 | Dec 19, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Biocryst | RAPIVAB | peramivir | SOLUTION;INTRAVENOUS | 206426-001 | Dec 19, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Biocryst | RAPIVAB | peramivir | SOLUTION;INTRAVENOUS | 206426-001 | Dec 19, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 peramivir
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biocryst | RAPIVAB | peramivir | SOLUTION;INTRAVENOUS | 206426-001 | Dec 19, 2014 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for peramivir
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Biocryst | Alpivab | peramivir | EMEA/H/C/004299 Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years. |
Withdrawn | no | no | no | 2018-04-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for peramivir
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovakia | 8712000 | SUBSTITUTED CYCLOPENTANE AND CYCLOPENTENE COMPOUNDS USEFUL AS NEURAMINIDASE INHIBITORS | See Plans and Pricing |
| Japan | 2009538822 | See Plans and Pricing | |
| South Korea | 20210076189 | 정맥내 항바이러스 치료 (INTRAVENOUS ANTIVIRAL TREATMENTS) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
