BENDAMUSTINE HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
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, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, 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. Eleven 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for BENDAMUSTINE HYDROCHLORIDE?
- What are the global sales for BENDAMUSTINE HYDROCHLORIDE?
- What is Average Wholesale Price for BENDAMUSTINE HYDROCHLORIDE?
Summary for BENDAMUSTINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 359 |
| Patent Applications: | 1,933 |
| 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 |
|---|---|
| Kyverna Therapeutics | Phase 1 |
| Stanford University | Phase 1 |
| Mayo Clinic | Phase 1 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Baxter Hlthcare Corp | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 216078-001 | Dec 15, 2022 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;IV (INFUSION) | 205376-001 | Dec 7, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;IV (INFUSION) | 204230-002 | Jun 5, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;IV (INFUSION) | 211001-002 | Jun 5, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 211530-002 | Dec 15, 2022 | DISCN | Yes | No | ⤷ 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 |
