MELPHALAN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Melphalan Hydrochloride, 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. Fifteen 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.
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Summary for MELPHALAN HYDROCHLORIDE
| International Patents: | 1 |
| US Patents: | 1 |
| Applicants: | 15 |
| NDAs: | 17 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 24 |
| Clinical Trials: | 861 |
| Patent Applications: | 923 |
| 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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209826-001 | May 28, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bpi Labs | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209197-001 | May 8, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Institutional | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 090299-001 | Oct 27, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 090303-001 | Oct 28, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Llc | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | POWDER;INTRAVENOUS | 209323-001 | Mar 6, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sagent Pharms Inc | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 201379-001 | Feb 28, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ 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 | CA 2022 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | CR 2022 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 23C1000 | France | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 301206 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 122023000007 | Germany | ⤷ Sign Up | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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