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Last Updated: June 28, 2022

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 and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-three countries.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. One supplier is 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 July 16, 2022. 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

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DrugPatentWatch® Estimated Generic Entry Opportunity 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
Jennifer AmengualPhase 3
Columbia UniversityPhase 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 three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FOLOTYN is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

See the table below for patents covering FOLOTYN around the world.

Country Patent Number Title Estimated Expiration
Japan 5005532 See Plans and Pricing
New Zealand 551082 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin See Plans and Pricing
South Korea 20110081327 TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN See Plans and Pricing
Australia 2005249516 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin See Plans and Pricing
Slovenia 1750716 See Plans and Pricing
New Zealand 576849 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin salts See Plans and Pricing
World Intellectual Property Organization (WIPO) 9802163 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Colorcon
Express Scripts
Boehringer Ingelheim
Moodys
McKinsey

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.