DrugPatentWatch Database Preview
TREANDA Drug Profile
» See Plans and Pricing
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.
US ANDA Litigation and 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.
There are eleven tentative approvals for the generic drug (bendamustine hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TREANDA
| International Patents: | 67 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 109 |
| Clinical Trials: | 92 |
| Patent Applications: | 723 |
| 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 |
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 |
|---|---|
| AstraZeneca | Phase 2 |
| Sunnybrook Health Sciences Centre | Phase 2 |
| Joseph Tuscano | Phase 2 |
Pharmacology for TREANDA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for TREANDA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TREANDA | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2014-06-19 |
| TREANDA | POWDER;IV (INFUSION) | bendamustine hydrochloride | 022249 | 2013-06-04 |
| TREANDA | SOLUTION;IV (INFUSION) | bendamustine hydrochloride | 022249 | 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-002 | May 1, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2009000742 | Start Trial |
| China | 104224703 | Start Trial |
| Japan | 5688195 | Start Trial |
| China | 105693620 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
