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Last Updated: March 19, 2024

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FOLOTYN Drug Patent Profile


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Which patents cover Folotyn, and what generic alternatives are available?

Folotyn is a drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-one patent family members in twenty-three countries.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.

DrugPatentWatch® Generic Entry Outlook for Folotyn

Folotyn was eligible for patent challenges on September 24, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2025. This may change due to patent challenges or generic licensing.

There have been two 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 is one tentative approval for the generic drug (pralatrexate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for FOLOTYN
Drug Prices for FOLOTYN

See drug prices for FOLOTYN

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOLOTYN
Generic Entry Date for FOLOTYN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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 FOLOTYN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
City of Hope Medical CenterPhase 1/Phase 2
Columbia UniversityPhase 3
Jennifer AmengualPhase 3

See all FOLOTYN clinical trials

Pharmacology for FOLOTYN
Paragraph IV (Patent) Challenges for FOLOTYN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOLOTYN Injection pralatrexate 20 mg/mL and 40 mg/2 mL 022468 4 2013-09-24

US Patents and Regulatory Information for FOLOTYN

FOLOTYN is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FOLOTYN is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FOLOTYN

Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FOLOTYN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for FOLOTYN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Allos Therapeutics Ltd Folotyn pralatrexate EMEA/H/C/002096
treatment of peripheral T-cell lymphoma,
Refused no no yes 2012-06-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FOLOTYN

When does loss-of-exclusivity occur for FOLOTYN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05249516
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 05272
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510895
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 65968
Estimated Expiration: ⤷  Try a Trial

China

Patent: 60734
Estimated Expiration: ⤷  Try a Trial

Patent: 2824346
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0080569
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 50716
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 50716
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005009176
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 77901
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 05532
Estimated Expiration: ⤷  Try a Trial

Patent: 08501038
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013559
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 087
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1082
Estimated Expiration: ⤷  Try a Trial

Patent: 6849
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 7276
Estimated Expiration: ⤷  Try a Trial

Patent: 065971
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 50716
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 50716
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 622
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 50716
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0609266
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1189692
Estimated Expiration: ⤷  Try a Trial

Patent: 1189693
Estimated Expiration: ⤷  Try a Trial

Patent: 070035490
Estimated Expiration: ⤷  Try a Trial

Patent: 110081327
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 13365
Estimated Expiration: ⤷  Try a Trial

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 FOLOTYN around the world.

Country Patent Number Title Estimated Expiration
Montenegro 01087 TRETMAN LIMFOMA T-ĆELIJA PRIMJENOM 10-PROPARGIL-10-DEAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN) ⤷  Try a Trial
Denmark 1750716 ⤷  Try a Trial
Serbia 50622 TRETMAN LIMFOMA T-ĆELIJA PRIMENOM 10-PROPARGIL-10-DIAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN) ⤷  Try a Trial
>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.