Treanda is a drug owned by Cephalon Inc. It is protected by 18 US drug patents filed from 2013 to 2023 out of which none have expired yet. Treanda's patents have been open to challenges since 02 May, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 26, 2031. Details of Treanda's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8445524 | Solid forms of bendamustine hydrochloride |
Mar, 2029
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8436190 (Pediatric) | Bendamustine pharmaceutical compositions |
Apr, 2031
(5 years from now) | Active |
| US8436190 | Bendamustine pharmaceutical compositions |
Oct, 2030
(4 years from now) | Active |
|
US8344006 (Pediatric) | Liquid formulations of bendamustine |
Mar, 2030
(4 years from now) | Active |
|
US8883836 (Pediatric) | Solid forms of bendamustine hydrochloride |
Sep, 2029
(3 years from now) | Active |
|
US8669279 (Pediatric) | Solid forms of bendamustine hydrochloride |
Sep, 2029
(3 years from now) | Active |
|
US9533955 (Pediatric) | Solid forms of bendamustine hydrochloride |
Sep, 2029
(3 years from now) | Active |
|
US8445524 (Pediatric) | Solid forms of bendamustine hydrochloride |
Sep, 2029
(3 years from now) | Active |
| US8344006 | Liquid formulations of bendamustine |
Sep, 2029
(3 years from now) | Active |
| US9533955 | Solid forms of bendamustine hydrochloride |
Mar, 2029
(3 years from now) | Active |
| US8669279 | Solid forms of bendamustine hydrochloride |
Mar, 2029
(3 years from now) | Active |
| US8883836 | Solid forms of bendamustine hydrochloride |
Mar, 2029
(3 years from now) | Active |
|
US8609863 (Pediatric) | Bendamustine pharmaceutical compositions |
Jul, 2026
(8 months from now) | Active |
|
US8895756 (Pediatric) | Bendamustine pharmaceutical compositions |
Jul, 2026
(8 months from now) | Active |
|
US8791270 (Pediatric) | Bendamustine pharmaceutical compositions |
Jul, 2026
(8 months from now) | Active |
| US8895756 | Bendamustine pharmaceutical compositions |
Jan, 2026
(2 months from now) | Active |
| US8609863 | Bendamustine pharmaceutical compositions |
Jan, 2026
(2 months from now) | Active |
| US8791270 | Bendamustine pharmaceutical compositions |
Jan, 2026
(2 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Treanda's patents.
Latest Legal Activities on Treanda's Patents
Given below is the list of recent legal activities going on the following patents of Treanda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2024 | US9533955 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jun, 2024 | US8344006 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 May, 2022 | US8895756 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 May, 2022 | US8883836 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jun, 2021 | US8609863 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Nov, 2020 | US8445524 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Oct, 2020 | US8436190 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jun, 2020 | US8344006 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jun, 2020 | US9533955 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 May, 2018 | US8895756 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Treanda and ongoing
litigations to
help you estimate the early arrival of Treanda generic.
Treanda's Litigations
Treanda been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 24, 2014, against patent number US8436190. The petitioner AGILA SPECIALTIES INC., challenged the validity of this patent, with Cephalon, Inc. as the respondent. Click below to track the latest information on how companies are challenging Treanda's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8791270 | October, 2015 |
Terminated-Settled
(25 Aug, 2016) | Cephalon, Inc. | Fresenius Kabi USA, LLC |
| US8895756 | November, 2015 |
Terminated-Settled
(25 Aug, 2016) | Cephalon, Inc. | Fresenius Kabi USA, LLC |
| US8791270 | October, 2015 |
Institution Denied
(13 Apr, 2016) | Cephalon, Inc. | AGILA SPECIALTIES INC. et al. |
| US8791270 | October, 2015 |
Terminated-Denied
(13 Apr, 2016) | Cephalon, Inc. | AGILA SPECIALTIES INC. |
| US8436190 | December, 2014 |
Terminated-Settled
(16 Nov, 2015) | Cephalon, Inc. | AGILA SPECIALTIES INC. |
FDA has granted some exclusivities to Treanda. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Treanda,
regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying
the generic
launch. Given below are details of the exclusivities granted to
Treanda.
Exclusivity Information
Treanda holds 5 exclusivities. All of its exclusivities have expired in 2022. Details of Treanda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-580) | Oct 31, 2011 |
| New Chemical Entity Exclusivity(NCE) | Mar 20, 2013 |
| Pediatric Exclusivity(PED) | May 01, 2016 |
| Orphan Drug Exclusivity(ODE) | Oct 31, 2015 |
| ODE*(ODE*) | Dec 07, 2022 |
Several oppositions have been filed on Treanda's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Treanda's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Treanda patents.
Treanda's Oppositions Filed in EPO
Treanda has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 12, 2013, by Helm Ag. This opposition was filed on patent number EP06718390A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06718390A | Jan, 2014 | Accord Healthcare | Revoked |
| EP06718390A | Jan, 2014 | Gallafent, Alison | Revoked |
| EP06718390A | Jan, 2014 | Taylor Wessing LLP | Revoked |
| EP06718390A | Jan, 2014 | Bendalis GmbH | Revoked |
| EP06718390A | Dec, 2013 | Actavis Group PTC ehf | Revoked |
| EP06718390A | Dec, 2013 | LEK Pharmaceuticals d.d. | Revoked |
| EP06718390A | Dec, 2013 | Helm AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Treanda is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Treanda's family patents as well as insights into
ongoing legal events
on those patents.
Treanda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Treanda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 26, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Treanda Generic API suppliers:
Bendamustine Hydrochloride is the generic name for the brand Treanda. 11 different companies have already filed for the generic of Treanda, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Treanda's generic
How can I launch a generic of Treanda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Treanda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Treanda's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Treanda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/vial and 100 mg/vial | 04 Jun, 2013 | 10 | 07 Dec, 2022 | 26 Oct, 2030 | Eligible |
| 90 mg/mL, 0.5 mL and 2 mL in single- dose vials | 19 Jun, 2014 | 1 | 23 Sep, 2029 |
Alternative Brands for Treanda
Treanda which is used for treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and indolent B-cell NHL., has several other brand drugs in the same treatment category and using the same active ingredient (Bendamustine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Eagle Pharms |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Bendamustine Hydrochloride. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bendamustine Hydrochloride, Treanda's active ingredient. Check the complete list of approved generic manufacturers for Treanda
About Treanda
Treanda is a drug owned by Cephalon Inc. It is used for treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and indolent B-cell NHL. Treanda uses Bendamustine Hydrochloride as an active ingredient. Treanda was launched by Cephalon in 2009.
Approval Date:
Treanda was approved by FDA for market use on 01 May, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Treanda is 01 May, 2009, its NCE-1 date is estimated to be 02 May, 2015.
Active Ingredient:
Treanda uses Bendamustine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Bendamustine Hydrochloride ingredient
Treatment:
Treanda is used for treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and indolent B-cell NHL.
Dosage:
Treanda is available in the following dosage forms - powder form for intravenous use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 25MG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 180MG/2ML (90MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| 45MG/0.5ML (90MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |