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Last Updated: December 5, 2019

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Pralatrexate - Generic Drug Details

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

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

Pralatrexate has forty-four 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.

Recent Clinical Trials for pralatrexate

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

SponsorPhase
University of Alabama at BirminghamEarly Phase 1
New York Medical CollegeEarly Phase 1
National Cancer Institute (NCI)Phase 1/Phase 2

See all pralatrexate clinical trials

Recent Litigation for pralatrexate

Identify potential future generic entrants

District Court Litigation
Case NameDate
ALLOS THERAPEUTICS, INC. v. DR. REDDY'S LABORATORIES, INC.2014-07-07
Allos Therapeutics Inc. v. Fresenius Kabi USA, LLC2014-06-19

See all pralatrexate litigation

Generic filers with tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MG/2MLINJECTABLE;INJECTION
  Start Trial  Start 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
Synonyms for pralatrexate
(2S)-2-((4-((1RS)-1-((2,4-Diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid
(2S)-2-({4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}amino)pentanedioic acid
(2S)-2-(4-(1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl)benzamido)pentanedioic acid
(2S)-2-[[4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl]amino]pentanedioic acid
(2S)-2-[[4-[1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid
(4-(1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl)benzoyl)-L-glutamic acid
10-Propargyl-10-deazaaminopterin
146464-95-1
2667AH
464P951
AB00443251_04
AB00443251-02
AB0095450
AB2000123
ABP000543
AC-28388
AC1L3WHA
AK162224
AKOS015966891
AM84423
AN-6340
API0005288
AX8248565
BCPP000101
CAS-146464-95-1
CHEBI:71223
CHEMBL1201746
CS-0504
D05589
DB06813
DSSTox_CID_28504
DSSTox_GSID_48578
DSSTox_RID_82776
DTXSID3048578
EX-A2142
Folotyn
Folotyn (TN)
FT-0673988
GTPL6840
HSDB 7786
HY-10446
J-008227
KS-00001CSH
L-Glutamic acid, N-(4-(1-((2,4-diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-
MolPort-009-679-397
N-(4-(1-((2,4-Diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-L-glutamic acid
N-[4-[1-[(2,4-Diamino-6-pteridinyl)methyl]-3-butyn-1-yl]benzoyl]-L-glutamic Acid
N-[4-[1-[(2,4-Diamino-6-pteridinyl)methyl]-3-butynyl]benzoyl]-L-glutamic Acid
N-{4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}-L-glutamic acid
NCGC00242596-01
NSC-754230
NSC754230
OGSBUKJUDHAQEA-WMCAAGNKSA-N
PDX
Pralatrexate (JAN/USAN/INN)
Pralatrexate [USAN:INN]
Pralatrexate(Folotyn)
Pralatrexate(Folotyn)/
pralatrexato
pralatrexatum
QC-3214
s1497
SB17353
SC-21536
SCHEMBL15075302
SCHEMBL21633
SR-01000941578
SR-01000941578-1
ST24049028
SW220187-1
Tox21_112906
Paragraph IV (Patent) Challenges for PRALATREXATE
Tradename Dosage Ingredient NDA Submissiondate
FOLOTYN SOLUTION;INTRAVENOUS pralatrexate 022468 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 FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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