MELPHALAN HYDROCHLORIDE Drug Patent Profile
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When do Melphalan Hydrochloride patents expire, and what generic alternatives are available?
Melphalan Hydrochloride is a drug marketed by 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, and Apotex. and is included in seventeen NDAs. There is one patent protecting this drug.
This drug has one patent family member in one country.
The generic ingredient in MELPHALAN HYDROCHLORIDE is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Melphalan Hydrochloride
A generic version of MELPHALAN HYDROCHLORIDE was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9th, 2009.
Summary for MELPHALAN HYDROCHLORIDE
International Patents: | 1 |
US Patents: | 1 |
Applicants: | 15 |
NDAs: | 17 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 861 |
Patent Applications: | 1,006 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MELPHALAN HYDROCHLORIDE |
DailyMed Link: | MELPHALAN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MELPHALAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital Heidelberg | Phase 1 |
University Hospital Dresden | Phase 1 |
German Cancer Research Center | Phase 1 |
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
MELPHALAN HYDROCHLORIDE is protected by one US patents.
Patents protecting MELPHALAN HYDROCHLORIDE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Llc | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 206018-001 | Dec 19, 2016 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Gland Pharma Ltd | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209826-001 | May 28, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bpi Labs | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209197-001 | May 8, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 HYDROCHLORIDE
See the table below for patents covering MELPHALAN HYDROCHLORIDE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2017002030 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MELPHALAN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2701720 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
2701720 | 122023000007 | Germany | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
2701720 | CA 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |