BENDAMUSTINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Bendamustine Hydrochloride, and what generic alternatives are available?
Bendamustine Hydrochloride is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Kindos, Mylan Labs Ltd, Nang Kuang Pharm Co, Baxter Hlthcare Corp, and Hospira. and is included in eleven NDAs.
The generic ingredient in BENDAMUSTINE HYDROCHLORIDE is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bendamustine Hydrochloride
A generic version of BENDAMUSTINE HYDROCHLORIDE was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.
Summary for BENDAMUSTINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 348 |
| Patent Applications: | 5,191 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENDAMUSTINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in BENDAMUSTINE HYDROCHLORIDE? | BENDAMUSTINE HYDROCHLORIDE excipients list |
| DailyMed Link: | BENDAMUSTINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for BENDAMUSTINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Philippe Armand, MD, PhD | Phase 2 |
| Genmab | Phase 2 |
| Cancer Research UK | Phase 2 |
Pharmacology for BENDAMUSTINE HYDROCHLORIDE
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for BENDAMUSTINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for BENDAMUSTINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE
| 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 |
| BENDEKA | Injection | bendamustine hydrochloride | 100 mg/4 mL (25 mg/mL) multiple-dose vials | 208194 | 1 | 2017-05-04 |
| TREANDA | Injection | bendamustine hydrochloride | 90 mg/mL, 0.5 mL and 2 mL in single- dose vials | 022249 | 1 | 2014-06-19 |
| TREANDA | Injection | bendamustine hydrochloride | 25 mg/vial and 100 mg/vial | 022249 | 10 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;IV (INFUSION) | 205574-001 | Dec 7, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare Corp | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 216078-001 | Dec 15, 2022 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;IV (INFUSION) | 205376-001 | Dec 7, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
