DrugPatentWatch Database Preview
Melphalan hydrochloride - Generic Drug Details
» See Plans and Pricing
What are the generic sources for melphalan hydrochloride and what is the scope of freedom to operate?
Melphalan hydrochloride
is the generic ingredient in three branded drugs marketed by Apotex, Actavis Llc, Alvogen, Bpi Labs Llc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Twi Pharms, Uswm, West-ward Pharms Int, and Acrotech, and is included in seventeen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Melphalan hydrochloride has seventy-four patent family members in eighteen countries.
There are twelve drug master file entries for melphalan hydrochloride. Ten suppliers are listed for this compound.
Summary for melphalan hydrochloride
| International Patents: | 74 |
| US Patents: | 4 |
| Tradenames: | 3 |
| Applicants: | 15 |
| NDAs: | 17 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 16 |
| Clinical Trials: | 796 |
| Patent Applications: | 760 |
| 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 |
|---|---|
| Sahlgrenska University Hospital, Sweden | Phase 1 |
| Oncopeptides AB | Phase 3 |
| Prof. Beck Popovic Maja | Phase 2 |
Pharmacology for melphalan hydrochloride
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EVOMELA | POWDER;INTRAVENOUS | melphalan hydrochloride | 207155 | 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 | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Ingenus Pharms Llc | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 210947-001 | Feb 18, 2020 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Institutional | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 090270-001 | Jun 9, 2009 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Gland Pharma Ltd | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209826-001 | May 28, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for melphalan hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2010004900 | Start Trial |
| South Korea | 20200106100 | Start Trial |
| South Korea | 101633479 | Start Trial |
| Mexico | 2014010323 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2021 - 2022
NCE-1 Patent Challenge Dates 2021 - 2022
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
