Folotyn Patent Expiration

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. 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6028071 Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors
Jul, 2022

(2 years ago)

Expired
US8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
May, 2025

(10 months from now)

Active
US7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
May, 2025

(10 months from now)

Active


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

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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

Folotyn has patent protection in a total of 23 countries. It's US patent count contributes only to 32.4% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Folotyn.

Family Patents

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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.

Market Authorisation Date:

Folotyn was approved by FDA for market use on 24 September, 2009.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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