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Melphalan hydrochloride - Generic Drug Details
What are the generic sources for melphalan hydrochloride and what is the scope of melphalan hydrochloride freedom to operate?
Melphalan hydrochloride
is the generic ingredient in three branded drugs marketed by Apotex Inc, Actavis Llc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Mylan Institutional, Par Sterile Products, Sagent Pharms, West-ward Pharms Int, and Spectrum Pharms, and is included in ten 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 fifty-five patent family members in seventeen countries.
There are twelve drug master file entries for melphalan hydrochloride. Nine suppliers are listed for this compound.
Summary for melphalan hydrochloride
| International Patents: | 55 |
| US Patents: | 4 |
| Tradenames: | 3 |
| Applicants: | 9 |
| NDAs: | 10 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 742 |
| Patent Applications: | 597 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for melphalan hydrochloride |
| DailyMed Link: | melphalan hydrochloride at DailyMed |
Pharmacology for melphalan hydrochloride
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
US Patents and Regulatory Information for melphalan hydrochloride
Expired US Patents for melphalan hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex Inc | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for melphalan hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Philippines | 12015500887 | ➤ Try a Free Trial |
| Hong Kong | 1211311 | ➤ Try a Free Trial |
| China | 104704007 | ➤ Try a Free Trial |
| China | 101959508 | ➤ Try a Free Trial |
| Hong Kong | 1213585 | ➤ Try a Free Trial |
| Australia | 2009241858 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
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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 verifification 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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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