MELPHALAN HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for melphalan hydrochloride and what is the scope of patent protection?
Melphalan hydrochloride
is the generic ingredient in four branded drugs marketed by Apotex, Actavis Llc, Almaject, Arthur Grp, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Uswm, Delcath Systems Inc, and Acrotech Biopharma, and is included in twenty NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Melphalan hydrochloride has one hundred and twenty-eight patent family members in twenty-six countries.
There are nine drug master file entries for melphalan hydrochloride. Fifteen suppliers are listed for this compound.
Summary for MELPHALAN HYDROCHLORIDE
International Patents: | 128 |
US Patents: | 18 |
Tradenames: | 4 |
Applicants: | 17 |
NDAs: | 20 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 869 |
Patent Applications: | 1,438 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MELPHALAN HYDROCHLORIDE |
What excipients (inactive ingredients) are in MELPHALAN HYDROCHLORIDE? | MELPHALAN HYDROCHLORIDE excipients list |
DailyMed Link: | MELPHALAN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MELPHALAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rising Tide Foundation | Phase 1/Phase 2 |
The Leukemia and Lymphoma Society | Phase 1/Phase 2 |
St. Louis Children's Hospital Foundation | Phase 1/Phase 2 |
Pharmacology for MELPHALAN HYDROCHLORIDE
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EVOMELA | Injection | melphalan hydrochloride | 50 mg/vial | 207155 | 1 | 2017-09-08 |
US Patents and Regulatory Information for MELPHALAN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 MELPHALAN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MELPHALAN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI1012301 | composições de melfalano injetáveis compreendendo um derivado de ciclodextrina e métodos de preparar e usar o mesmo | ⤷ Sign Up |
South Korea | 101522918 | ⤷ Sign Up | |
Australia | 2010253905 | Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MELPHALAN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2701720 | CR 2022 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
2701720 | CA 2022 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
2701720 | 3/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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