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Bendamustine hydrochloride - Generic Drug Details
What are the generic sources for bendamustine hydrochloride and what is the scope of bendamustine hydrochloride patent protection?
Bendamustine hydrochloride has ninety-four patent family members in thirty-one countries.
There are twenty-two drug master file entries for bendamustine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for bendamustine hydrochloride
International Patents: | 94 |
US Patents: | 22 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 22 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 73 |
Clinical Trials: | 255 |
Formulation / Manufacturing: | see details |
Drug Prices: | see low prices |
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
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 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Non-Orange Book US Patents for bendamustine hydrochloride
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.
International Patents for bendamustine hydrochloride
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