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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Healthtrust
Boehringer Ingelheim
Federal Trade Commission
McKesson
Cantor Fitzgerald
Covington
Deloitte
Cipla

Generated: June 22, 2018

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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 pralatrexate freedom to operate?

Pralatrexate
is the generic ingredient in one branded drug marketed by Allos 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-two patent family members in twenty-one countries.

There are two drug master file entries for pralatrexate. One supplier is listed for this compound. There is one tentative approval for this compound.
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]phenyl}formamido)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
3B1-001405
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
D02LWU
D05589
DB06813
DSSTox_CID_28504
DSSTox_GSID_48578
DSSTox_RID_82776
DTXSID3048578
Folotyn
Folotyn (TN)
FT-0673988
GTPL6840
HE069856
HE250885
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
Pralatrexate (JAN/USAN/INN)
Pralatrexate [USAN:INN]
Pralatrexate(Folotyn)
Pralatrexate(Folotyn)/
pralatrexato
pralatrexatum
QC-3214
s1497
SC-21536
SCHEMBL15075302
SCHEMBL21633
SR-01000941578
SR-01000941578-1
ST24049028
Tox21_112906
Tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial20MG/1MLINJECTABLE;INJECTION
➤ Try a Free Trial➤ Try a Free Trial40MG/2MLINJECTABLE;INJECTION

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
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Non-Orange Book US Patents for pralatrexate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,323,205 Combinations of 10-propargyl-10-deazaaminopterin and taxols and methods of using same in the treatment of tumors ➤ Try a Free Trial
7,939,530 Treatment of lymphoma using 10-propargyl-10-deazaaminopterin and gemcitabine ➤ Try a Free Trial
8,168,404 Methods to treat cancer with 10-propargyl-10-deazaaminopterin and methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin ➤ Try a Free Trial
8,263,354 Methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
Boehringer Ingelheim
Moodys
Dow
Johnson and Johnson
Cipla
Federal Trade Commission
Fish and Richardson

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.