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Last Updated: April 13, 2024

Pralatrexate - Generic Drug Details


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What are the generic drug sources for pralatrexate and what is the scope of freedom to operate?

Pralatrexate is the generic ingredient in one branded drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are two drug master file entries for pralatrexate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pralatrexate
Generic Entry Date for pralatrexate*:
Constraining patent/regulatory exclusivity:
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 pralatrexate

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

SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 1
University of BolognaPhase 1
Merck Sharp & Dohme Corp.Phase 1

See all pralatrexate clinical trials

Generic filers with tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MG/2MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial20MG/1MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pralatrexate
Paragraph IV (Patent) Challenges for PRALATREXATE
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 pralatrexate

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
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ⤷  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 pralatrexate

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

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 pralatrexate

Country Patent Number Title Estimated Expiration
South Korea 20110081327 TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN ⤷  Try a Trial
Croatia P20080569 ⤷  Try a Trial
Hong Kong 1177901 使用 -炔丙基- -去氮雜氨基蝶呤治療 細胞淋巴瘤 (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN 10--10- T) ⤷  Try a Trial
South Korea 101189692 ⤷  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.