Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 15, 2019

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FOLOTYN Drug Profile

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When do Folotyn patents expire, 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-three patent family members in twenty-two 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.

Drug patent expirations by year for FOLOTYN
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

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SponsorPhase
City of Hope Medical CenterPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2
Columbia UniversityPhase 3

See all FOLOTYN clinical trials

Recent Litigation for FOLOTYN

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 FOLOTYN litigation

Pharmacology for FOLOTYN
Synonyms for FOLOTYN
(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 (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
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 FOLOTYN
Tradename Dosage Ingredient NDA Submissiondate
FOLOTYN SOLUTION;INTRAVENOUS pralatrexate 022468 2013-09-24

US Patents and Regulatory Information for FOLOTYN

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   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   Start Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No   Start Trial   Start Trial Y Y   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:

Harvard Business School
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Johnson and Johnson
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Medtronic

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 verifification 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.