Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
Fuji
McKinsey
Colorcon
Deloitte
Cipla
Baxter
McKesson
Cantor Fitzgerald

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208194

« Back to Dashboard

NDA 208194 describes BENDEKA, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BENDEKA profile page.

The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 208194
Tradename:BENDEKA
Applicant:Eagle Pharms
Ingredient:bendamustine hydrochloride
Patents:13
Formulation / Manufacturing:see details
Pharmacology for NDA: 208194
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 208194
Suppliers and Packaging for NDA: 208194
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194 NDA Teva Pharmaceuticals USA, Inc. 63459-348 63459-348-04 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) > 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/4ML (25MG/ML)
Approval Date:Dec 7, 2015TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Aug 11, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Patent:➤ SubscribePatent Expiration:Jul 12, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:➤ SubscribePatent Expiration:Mar 15, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Moodys
Cipla
Covington
Argus Health
Novartis
Healthtrust
Baxter
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot