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BELRAPZO Drug Profile
» See Plans and Pricing
Which patents cover Belrapzo, and when can generic versions of Belrapzo launch?
Belrapzo is a drug marketed by Eagle Pharms and is included in one NDA. There are six patents protecting this drug.
This drug has fifty-four patent family members in thirty-one countries.
The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Belrapzo
There are ten tentative approvals for the generic drug (bendamustine hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for BELRAPZO
| International Patents: | 54 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | BELRAPZO at DailyMed |
Pharmacology for BELRAPZO
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for BELRAPZO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BELRAPZO | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 205580 | 2018-07-17 |
US Patents and Regulatory Information for BELRAPZO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | BELRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | 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 | 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 | BELRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | 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 | |||
| >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 BELRAPZO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3158991 | Start Trial |
| Japan | 5726833 | Start Trial |
| Mexico | 2007008562 | Start Trial |
| Japan | 2013056902 | Start Trial |
| Lithuania | 2528602 | Start Trial |
| European Patent Office | 1863452 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
