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Pralatrexate - Generic Drug Details

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 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-three patent family members in twenty-two 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.

Summary for pralatrexate

International Patents:	43
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	56
Clinical Trials:	35
Patent Applications:	2,142
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pralatrexate
DailyMed Link:	pralatrexate at DailyMed

Pharmacology for pralatrexate

Drug Class	Folate Analog Metabolic Inhibitor

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

Generic filers with tentative approvals for PRALATREXATE

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	40MG/2ML	INJECTABLE;INJECTION
➤ Sign Up	➤ Sign Up	20MG/1ML	INJECTABLE;INJECTION

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

US Patents and Regulatory Information for pralatrexate

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

International Patents for pralatrexate

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Country	Patent Number	Estimated Expiration
Japan	2008501038	➤ Sign Up
Japan	2001505537	➤ Sign Up
Norway	20065971	➤ Sign Up
European Patent Office	1750716	➤ Sign Up
South Korea	101189692	➤ Sign Up
South Korea	20070035490	➤ Sign Up
Montenegro	01087	➤ Sign Up
Country	Patent Number	Estimated Expiration