Folotyn is a drug owned by Acrotech Biopharma Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 2 drug patents are active and 1 has expired. Folotyn's patents have been open to challenges since 24 September, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be May 31, 2025. Details of Folotyn's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8299078 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin |
May, 2025
(5 months from now) | Active |
| US7622470 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin |
May, 2025
(5 months from now) | Active |
| US6028071 | Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors |
Jul, 2022
(2 years ago) |
Expired
|
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 Folotyn's patents.
Latest Legal Activities on Folotyn's Patents
Given below is the list of recent legal activities going on the following patents of Folotyn.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Apr, 2024 | US8299078 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2021 | US7622470 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2020 | US8299078 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 14 Jan, 2020 | US7622470 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 14 Jan, 2020 | US8299078 (Litigated) |
| Post Issue Communication - Certificate of Correction | 02 May, 2017 | US7622470 (Litigated) |
| Post Issue Communication - Certificate of Correction | 12 Jan, 2016 | US8299078 (Litigated) |
| Post Issue Communication - Certificate of Correction | 01 Feb, 2013 | US8299078 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 30 Oct, 2012 | US8299078 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 30 Oct, 2012 | US8299078 (Litigated) |
FDA has granted several exclusivities to Folotyn. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Folotyn, 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 Folotyn.
Exclusivity Information
Folotyn holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Folotyn's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 24, 2014 |
| Orphan Drug Exclusivity(ODE) | Sep 24, 2016 |
US patents provide insights into the exclusivity only within the United States, but Folotyn 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 Folotyn's family patents as well as insights into ongoing legal events on those patents.
Folotyn's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Folotyn's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 31, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Folotyn Generics:
There are no approved generic versions for Folotyn as of now.
How can I launch a generic of Folotyn before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Folotyn's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Folotyn'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 Folotyn -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/mL and 40 mg/2 mL | 24 Sep, 2013 | 4 | 31 May, 2025 |
About Folotyn
Folotyn is a drug owned by Acrotech Biopharma Inc. It is used for treating patients with relapsed or refractory peripheral T-cell lymphoma. Folotyn uses Pralatrexate as an active ingredient. Folotyn was launched by Acrotech Biopharma in 2009.
Approval Date:
Folotyn was approved by FDA for market use on 24 September, 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 Folotyn is 24 September, 2009, its NCE-1 date is estimated to be 24 September, 2013.
Active Ingredient:
Folotyn uses Pralatrexate as the active ingredient. Check out other Drugs and Companies using Pralatrexate ingredient
Treatment:
Folotyn is used for treating patients with relapsed or refractory peripheral T-cell lymphoma.
Dosage:
Folotyn is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG/ML (20MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 40MG/2ML (20MG/ML) | SOLUTION | Prescription | INTRAVENOUS |