Melphalan flufenamide hydrochloride - Generic Drug Details
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What are the generic drug sources for melphalan flufenamide hydrochloride and what is the scope of patent protection?
Melphalan flufenamide hydrochloride
is the generic ingredient in one branded drug marketed by Oncopeptides Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Melphalan flufenamide hydrochloride has ninety-five patent family members in twenty-seven countries.
Summary for melphalan flufenamide hydrochloride
| International Patents: | 95 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 8 |
| DailyMed Link: | melphalan flufenamide hydrochloride at DailyMed |
Recent Clinical Trials for melphalan flufenamide hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| PRA Health Sciences | Phase 1/Phase 2 |
| Oncopeptides AB | Phase 3 |
| Oncopeptides AB | Phase 2 |
US Patents and Regulatory Information for melphalan flufenamide hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Oncopeptides Ab | PEPAXTO | melphalan flufenamide hydrochloride | POWDER;INTRAVENOUS | 214383-001 | Feb 26, 2021 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Oncopeptides Ab | PEPAXTO | melphalan flufenamide hydrochloride | POWDER;INTRAVENOUS | 214383-001 | Feb 26, 2021 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Oncopeptides Ab | PEPAXTO | melphalan flufenamide hydrochloride | POWDER;INTRAVENOUS | 214383-001 | Feb 26, 2021 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Oncopeptides Ab | PEPAXTO | melphalan flufenamide hydrochloride | POWDER;INTRAVENOUS | 214383-001 | Feb 26, 2021 | DISCN | Yes | No | 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 |
International Patents for melphalan flufenamide hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012146625 | See Plans and Pricing | |
| Israel | 228889 | See Plans and Pricing | |
| Israel | 265457 | תכשיר ליופילי של דיפפטידים ציטוטוקסים (Lyophilized preparation of cytotoxic dipeptides) | See Plans and Pricing |
| Cyprus | 1122483 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
