MYLERAN Drug Patent Profile
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When do Myleran patents expire, and what generic alternatives are available?
Myleran is a drug marketed by Woodward Specl and is included in one NDA.
The generic ingredient in MYLERAN is busulfan. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the busulfan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Myleran
A generic version of MYLERAN was approved as busulfan by AM REGENT on December 22nd, 2015.
Summary for MYLERAN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 91 |
| Patent Applications: | 4,685 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MYLERAN |
| What excipients (inactive ingredients) are in MYLERAN? | MYLERAN excipients list |
| DailyMed Link: | MYLERAN at DailyMed |
Recent Clinical Trials for MYLERAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jazz Pharmaceuticals | Phase 1/Phase 2 |
| Baptist Health South Florida | Phase 1/Phase 2 |
| St. Jude Children's Research Hospital | Phase 1/Phase 2 |
Pharmacology for MYLERAN
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for MYLERAN
US Patents and Regulatory Information for MYLERAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Woodward Specl | MYLERAN | busulfan | TABLET;ORAL | 009386-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 |
EU/EMA Drug Approvals for MYLERAN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pierre Fabre Medicament | Busilvex | busulfan | EMEA/H/C/000472 Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients. |
Authorised | no | no | no | 2003-07-09 | |
| Fresenius Kabi Deutschland GmbH | Busulfan Fresenius Kabi | busulfan | EMEA/H/C/002806 Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients. |
Authorised | yes | no | no | 2014-09-22 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
