BELRAPZO Drug Patent Profile
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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 ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-five patent family members in thirty countries.
The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Belrapzo
A generic version of BELRAPZO was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.
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Questions you can ask:
- What is the 5 year forecast for BELRAPZO?
- What are the global sales for BELRAPZO?
- What is Average Wholesale Price for BELRAPZO?
Summary for BELRAPZO
International Patents: | 65 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 4 |
Drug Prices: | Drug price information for BELRAPZO |
What excipients (inactive ingredients) are in BELRAPZO? | BELRAPZO excipients list |
DailyMed Link: | BELRAPZO at DailyMed |


Recent Clinical Trials for BELRAPZO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
City of Hope Medical Center | Phase 1 |
National Cancer Institute (NCI) | Phase 1 |
National Cancer Institute (NCI) | Phase 3 |
Pharmacology for BELRAPZO
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for BELRAPZO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BELRAPZO | Injection | bendamustine hydrochloride | 100 mg/4 mL (25 mg/mL) multiple-dose vials | 205580 | 1 | 2018-07-17 |
US Patents and Regulatory Information for BELRAPZO
BELRAPZO is protected by seventeen US patents.
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;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | 9,572,796 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | 9,572,797 | ⤷ Try for Free | ⤷ Try for Free | |||
Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | 8,791,270 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | 11,844,783 | ⤷ Try for Free | ⤷ Try for Free | |||
Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | 12,138,248 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | 10,010,533 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
>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
When does loss-of-exclusivity occur for BELRAPZO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2877
Patent: COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 93582
Patent: COMPOSITIONS PHARMACEUTIQUES DE BENDAMUSTINE (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BELRAPZO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2574334 | Compositions pharmaceutiques de bendamustine pour lyophilisation (Bendamustine pharmaceutical compositions for lyophilisation) | ⤷ Try for Free |
Spain | 2405611 | ⤷ Try for Free | |
Croatia | P20210915 | ⤷ Try for Free | |
Taiwan | I380830 | ⤷ Try for Free | |
European Patent Office | 3895694 | FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE) | ⤷ Try for Free |
Singapore | 158870 | BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BELRAPZO
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