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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.

Summary for pralatrexate

International Patents:	42
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	51
Clinical Trials:	33
Patent Applications:	1,713
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]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
		20MG/1ML	INJECTABLE;INJECTION
		40MG/2ML	INJECTABLE;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
Allos	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No			Y	Y
Allos	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes
Allos	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes

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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
7,939,530	Treatment of lymphoma using 10-propargyl-10-deazaaminopterin and gemcitabine
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
8,263,354	Methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin

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International Patents for pralatrexate

Country	Document Number	Estimated Expiration
Canada	2565968
European Patent Office	2258702
Norway	20065971
Portugal	944389