TREANDA Drug Patent Profile
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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-seven patent family members in twenty-two countries.
The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Treanda
Treanda was eligible for patent challenges on March 20, 2012.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 23, 2030. This may change due to patent challenges or generic licensing.
There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TREANDA
International Patents: | 67 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 103 |
Patent Applications: | 2,150 |
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 |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for TREANDA
Generic Entry Date for TREANDA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;IV (INFUSION) |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TREANDA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Incyte Corporation | Phase 3 |
Loxo Oncology, Inc. | Phase 3 |
University Health Network, Toronto | Phase 2 |
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 three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TREANDA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TREANDA
Bendamustine pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid forms of bendamustine hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
Solid forms of bendamustine hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
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 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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: See Plans and Pricing
Patent: 15207940
Estimated Expiration: See Plans and Pricing
Patent: 16203246
Estimated Expiration: See Plans and Pricing
Patent: 16247123
Estimated Expiration: See Plans and Pricing
Patent: 18202107
Estimated Expiration: See Plans and Pricing
Canada
Patent: 35899
Estimated Expiration: See Plans and Pricing
China
Patent: 2164579
Estimated Expiration: See Plans and Pricing
Patent: 4224703
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 26306
Estimated Expiration: See Plans and Pricing
Patent: 89029
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 11462
Estimated Expiration: See Plans and Pricing
Japan
Patent: 70335
Estimated Expiration: See Plans and Pricing
Patent: 12503666
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 11002936
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
South Korea | 20170096221 | 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) | See Plans and Pricing |
Australia | 2015207940 | Liquid Formulations of Bendamustine | See Plans and Pricing |
Japan | 2008526991 | See Plans and Pricing | |
South Korea | 20160098530 | 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |