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-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. Eleven 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.
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Summary for TREANDA
| International Patents: | 66 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 107 |
| Patent Applications: | 1,933 |
| 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 |
|---|---|
| Regeneron Pharmaceuticals | Phase 3 |
| 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 |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-003 | Sep 13, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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
Patent: Liquid formulations of bendamustine
Estimated Expiration: ⤷ Sign Up
Patent: 15207940
Patent: Liquid Formulations of Bendamustine
Estimated Expiration: ⤷ Sign Up
Patent: 16203246
Patent: Liquid formulations of bendamustine
Estimated Expiration: ⤷ Sign Up
Patent: 16247123
Patent: Liquid formulations of bendamustine
Estimated Expiration: ⤷ Sign Up
Patent: 18202107
Patent: Liquid formulations of bendamustine
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 35899
Patent: FORMULATIONS LIQUIDES DE BENDAMUSTINE (LIQUID FORMULATIONS OF BENDAMUSTINE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2164579
Patent: Liquid formulations of bendamustine
Estimated Expiration: ⤷ Sign Up
Patent: 4224703
Patent: Liquid Formulations Of Bendamustine
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 26306
Patent: FORMULATIONS LIQUIDES DE BENDAMUSTINE (LIQUID FORMULATIONS OF BENDAMUSTINE)
Estimated Expiration: ⤷ Sign Up
Patent: 89029
Patent: Formulations liquides de bendamustine (Liquid formulations of bendamustine)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 11462
Patent: 苯達莫司汀的液體製劑 (LIQUID FORMULATIONS OF BENDAMUSTINE)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 70335
Estimated Expiration: ⤷ Sign Up
Patent: 12503666
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11002936
Patent: FORMULACIONES LIQUIDAS DE BENDAMUSTINA. (LIQUID FORMULATIONS OF BENDAMUSTINE.)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 2009296734 | Liquid formulations of bendamustine | ⤷ Sign Up |
| Eurasian Patent Organization | 013324 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ЛИОФИЛИЗАЦИИ (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILIZATION) | ⤷ Sign Up |
| China | 102164579 | Liquid formulations of bendamustine | ⤷ Sign Up |
| China | 101980698 | Novel solid forms of bendamustine hydrochloride | ⤷ Sign Up |
| Chile | 2009000742 | Forma solida cristalina de clorhidrato de bendamustina, designada como forma 1; composicion farmaceutica que la comprende; metodo de preparacion de la composicion farmaceutica; y uso en el tratamiento de leucemia linfocitica cronica, enfermedad de hodgkin, linfoma no hodgkiniano, mieloma multiple o cancer de mama. | ⤷ Sign Up |
| Japan | 5536753 | ⤷ Sign Up | |
| European Patent Office | 2271315 | FORMES SOLIDES D'HYDROCHLORURE DE BENDAMUSTINE (SOLID FORMS OF BENDAMUSTINE HYDROCHLORIDE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 verification 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.
ISSN: 2162-2639
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