DrugPatentWatch Database Preview

FOLOTYN Drug Profile

« Back to Dashboard

Which patents cover Folotyn, and what generic alternatives are available?

Folotyn is a drug marketed by Allos and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pralatrexate profile page.

Summary for FOLOTYN

US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	50
Clinical Trials:	18
Patent Applications:	911
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOLOTYN
DailyMed Link:	FOLOTYN at DailyMed

Generic Entry Opportunity Date for FOLOTYN

NDA:

022468

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.

Pharmacology for FOLOTYN

Drug Class

Folate Analog Metabolic Inhibitor

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]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 (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

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

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
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			Y	Y
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
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

Paragraph IV (Patent) Challenges for FOLOTYN

Drugname	Dosage	Strength	RLD	Date
	Injection	20 mg/mL and 40 mg/2 mL

International Patents for FOLOTYN

Country	Document Number	Estimated Expiration
Japan	5271677
South Africa	200609266
Mexico	PA06013559
Spain	2313737
European Patent Office	2258702
South Korea	101189693
Austria	407677