DrugPatentWatch Database Preview
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.
DrugPatentWatch® Generic Entry Outlook for Belrapzo
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 12, 2026. This may change due to patent challenges or generic licensing.
There are twelve 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 |
| What excipients (inactive ingredients) are in BELRAPZO? | BELRAPZO excipients list |
| DailyMed Link: | BELRAPZO at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for BELRAPZO
Generic Entry Date for BELRAPZO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;IV (INFUSION) |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006076620 | Start Trial |
| Japan | 2013518130 | Start Trial |
| Portugal | 2528602 | Start Trial |
| Taiwan | 200637614 | Start Trial |
| South Korea | 20170096221 | Start Trial |
| Canada | 2593582 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
