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Bendamustine hydrochloride - Generic Drug Details
What are the generic drug sources for bendamustine hydrochloride and what is the scope of bendamustine hydrochloride patent protection?
Bendamustine hydrochloride
is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Breckenridge Pharm, Glenmark Pharms Ltd, Mylan Labs Ltd, Cephalon, and Eagle Pharms, and is included in seven NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Bendamustine hydrochloride has ninety-four patent family members in thirty-one countries.
There are twenty-two drug master file entries for bendamustine hydrochloride. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for bendamustine hydrochloride
| International Patents: | 94 |
| US Patents: | 24 |
| Tradenames: | 4 |
| Applicants: | 6 |
| NDAs: | 7 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 267 |
| Patent Applications: | 815 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bendamustine hydrochloride |
| DailyMed Link: | bendamustine hydrochloride at DailyMed |
Pharmacology for bendamustine hydrochloride
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
Tentative approvals for BENDAMUSTINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 100MG | INJECTABLE; INJECTION |
US Patents and Regulatory Information for bendamustine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Eagle Pharms | BALRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| 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 bendamustine hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| San Marino | T201700043 | ➤ Try a Free Trial |
| Japan | 2015510939 | ➤ Try a Free Trial |
| European Patent Office | 3150197 | ➤ 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, 2018, www.DrugPatentWatch.com.
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