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Generated: August 19, 2017
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 West-ward Pharms Int, Apotex Inc, Actavis Llc, Spectrum Pharms, Mylan Institutional, Par Sterile Products, and Sagent Pharms, and is included in eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 3 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: see list | 12 |
| Suppliers / Packagers: see list | 7 |
| Bulk Api Vendors: see list | 8 |
| Clinical Trials: see list | 2,860 |
| Patent Applications: see list | 492 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | melphalan hydrochloride at DailyMed |
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
| 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 | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan Institutional | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 090270-001 | Jun 9, 2009 | AP | RX | No | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Apotex Inc | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Llc | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 206018-001 | Dec 19, 2016 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Par Sterile Products | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 204773-001 | Aug 22, 2016 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Inc | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,635,773 | Sulfoalkyl ether cyclodextrin compositions | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013130666 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2016210707 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20110010742 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 208956 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2615385 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ 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 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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