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Melphalan hydrochloride - Generic Drug Details
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 Inc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Institutional, Noratech, Par Sterile Products, Sagent Pharms Inc, Us Worldmeds Llc, West-ward Pharms Int, and Acrotech, and is included in fourteen 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-one patent family members in seventeen countries.
There are twelve drug master file entries for melphalan hydrochloride. Twelve suppliers are listed for this compound.
Summary for melphalan hydrochloride
| International Patents: | 71 |
| US Patents: | 4 |
| Tradenames: | 3 |
| Applicants: | 13 |
| NDAs: | 14 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 12 |
| Bulk Api Vendors: | 16 |
| Clinical Trials: | 770 |
| Patent Applications: | 713 |
| 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 |
|---|---|
| General Oncology, Inc. | Phase 2 |
| PRA Health Sciences | Phase 1/Phase 2 |
| Dutch Cancer Society | Phase 2 |
Recent Litigation for melphalan hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA | 2019-05-23 |
| MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED | 2018-03-29 |
| CyDex Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-12-20 |
Pharmacology for melphalan hydrochloride
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Synonyms for melphalan hydrochloride
| (2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid;hydrochloride |
| (S)-2-amino-3-(4-(bis(2-chloroethyl)amino)phenyl)propanoic acid hydrochloride |
| 1VXP4V453T |
| 223M072 |
| 3223-07-2 |
| 4-[Bis(2-chloroethyl)-amino]-L-phenylalanine hydrochloride |
| 4-[bis(2-chloroethyl)-amino]-phenylalanine hydrochloride |
| AC-25549 |
| AI3-26377 |
| AKOS025401785 |
| Alanine nitrogen mustard hydrochloride |
| ALANINE, 3-(p-(BIS(2-CHLOROETHYL)AMINO)PHENYL)-, MONOHYDROCHLORIDE, L- |
| Alkeran (GlaxoSmith) |
| ALKERAN (TN) |
| Alkeran hydrochloride |
| BC208857 |
| CB 3025 hydrochloride |
| CHEMBL1200863 |
| CTK8G0783 |
| D08173 |
| DTXSID60872785 |
| Evomela (TN) |
| FT-0773182 |
| L-3-(p-(Bis(2-chloroethyl)amino)phenyl)alanine monohydrochloride |
| L-Alanine, 3-(p-(bis(2-chloroethyl)amino)phenyl)-, hydrochloride |
| L-Alanine, hydrochloride |
| L-Phenylalanine mustard hydrochloride |
| L-Phenylalanine, 4-(bis(2-chloroethyl)amino)-, monohydrochloride (9CI) |
| L-Phenylalanine, monohydrochloride |
| L-Sarcolysine hydrochloride |
| Melfalan hydrochloride |
| Melphalan HCl |
| NSC8806 |
| OUUYBRCCFUEMLH-YDALLXLXSA-N |
| Phenylalanine mustard hydrochloride |
| SCHEMBL41335 |
| SK 15673 |
| UNII-1VXP4V453T |
| UNII-GEG3Q4FC64 component OUUYBRCCFUEMLH-YDALLXLXSA-N |
| WLN: QVYZ1R DN2G2G &GH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Institutional | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 090299-001 | Oct 27, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Noratech | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 211463-001 | Sep 13, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Us Worldmeds Llc | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 207032-001 | May 3, 2019 | DISCN | 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 |
|---|---|---|
| Eurasian Patent Organization | 201000828 | Start Trial |
| Philippines | 12015500887 | Start Trial |
| Japan | 2018052991 | Start Trial |
| >Country | >Patent 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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