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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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