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Bendamustine hydrochloride - Generic Drug Details
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What are the generic drug sources for bendamustine hydrochloride and what is the scope of patent protection?
Bendamustine hydrochloride
is the generic ingredient in three branded drugs marketed by Cephalon and Eagle Pharms, and is included in three 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 one hundred and eighteen patent family members in thirty-two countries.
There are twenty-three drug master file entries for bendamustine hydrochloride. Three suppliers are listed for this compound. There are eleven tentative approvals for this compound.
Summary for bendamustine hydrochloride
| International Patents: | 118 |
| US Patents: | 24 |
| Tradenames: | 3 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 23 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 109 |
| Clinical Trials: | 302 |
| Patent Applications: | 1,200 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bendamustine hydrochloride |
| DailyMed Link: | bendamustine hydrochloride at DailyMed |
Recent Clinical Trials for bendamustine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Loxo Oncology, Inc. | Phase 3 |
| Sunnybrook Health Sciences Centre | Phase 2 |
| Karyopharm Therapeutics Inc | Phase 1/Phase 2 |
Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 100MG/VIAL | POWDER;IV (INFUSION) |
| Start Trial | Start Trial | 25MG/VIAL | POWDER;IV (INFUSION) |
| Start Trial | Start Trial | 100MG/VIAL | POWDER;IV (INFUSION) |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for bendamustine hydrochloride
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BELRAPZO | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 205580 | 2018-07-17 |
| BENDEKA | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 208194 | 2017-05-04 |
| TREANDA | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2013-06-04 |
| TREANDA | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2013-06-04 |
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) | 022249-002 | May 1, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2015207940 | Start Trial |
| Spain | 2405611 | Start Trial |
| Spain | 2609106 | Start Trial |
| China | 104224703 | Start Trial |
| Serbia | 55491 | Start Trial |
| China | 105693620 | Start Trial |
| Argentina | 052877 | 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 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.
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