TREANDA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Treanda, and when can generic versions of Treanda launch?
Treanda is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.
This drug has sixty-six patent family members in twenty-one countries.
The generic ingredient in TREANDA 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 Treanda
A generic version of TREANDA was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.
Summary for TREANDA
International Patents: | 66 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 129 |
Clinical Trials: | 106 |
Patent Applications: | 3,599 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TREANDA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TREANDA |
What excipients (inactive ingredients) are in TREANDA? | TREANDA excipients list |
DailyMed Link: | TREANDA at DailyMed |


Recent Clinical Trials for TREANDA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vaishalee Kenkre | Phase 1/Phase 2 |
University of Wisconsin, Madison | Phase 1/Phase 2 |
Epizyme, Inc. | Phase 1/Phase 2 |
Pharmacology for TREANDA
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for TREANDA
Paragraph IV (Patent) Challenges for TREANDA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 TREANDA
TREANDA is protected by two US patents.
Patents protecting TREANDA
Bendamustine pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid forms of bendamustine hydrochloride
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-003 | Sep 13, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for TREANDA
When does loss-of-exclusivity occur for TREANDA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09296734
Estimated Expiration: ⤷ Try a Trial
Patent: 15207940
Estimated Expiration: ⤷ Try a Trial
Patent: 16203246
Estimated Expiration: ⤷ Try a Trial
Patent: 16247123
Estimated Expiration: ⤷ Try a Trial
Patent: 18202107
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 35899
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2164579
Estimated Expiration: ⤷ Try a Trial
Patent: 4224703
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 26306
Estimated Expiration: ⤷ Try a Trial
Patent: 89029
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 11462
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 70335
Estimated Expiration: ⤷ Try a Trial
Patent: 12503666
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11002936
Estimated Expiration: ⤷ Try a Trial
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 TREANDA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 101119708 | Bendamustine pharmaceutical compositions | ⤷ Try a Trial |
European Patent Office | 2889029 | Formulations liquides de bendamustine (Liquid formulations of bendamustine) | ⤷ Try a Trial |
Canada | 2718939 | NOUVELLES FORMES SOLIDES D'HYDROCHLORURE DE BENDAMUSTINE (NOVEL SOLID FORMS OF BENDAMUSTINE HYDROCHLORIDE) | ⤷ Try a Trial |
China | 103550159 | Novel solid forms of bendamustine hydrochloride | ⤷ Try a Trial |
Hong Kong | 1220966 | 鹽酸苯達莫司汀固體形式 (SOLID FORMS OF BENDAMUSTINE HYDROCHLORIDE) | ⤷ Try a Trial |
Australia | 2009296734 | Liquid formulations of bendamustine | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |