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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-four patent family members in twenty-three 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.

US ANDA Litigation and Generic Entry Outlook for Folotyn

Folotyn was eligible for patent challenges on September 24, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 16, 2022. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (pralatrexate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FOLOTYN

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	58
Clinical Trials:	19
Patent Applications:	1,317
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.

Recent Clinical Trials for FOLOTYN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2
Columbia University	Phase 3

See all FOLOTYN clinical trials

Recent Litigation for FOLOTYN

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ALLOS THERAPEUTICS, INC. v. DR. REDDY'S LABORATORIES, INC.	2014-07-07
Allos Therapeutics Inc. v. Fresenius Kabi USA, LLC	2014-06-19

See all FOLOTYN litigation

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)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			Y	Y
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes			Y	Y
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes
Acrotech	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes

International Patents for FOLOTYN

Country	Patent Number	Estimated Expiration
Portugal	1750716
Japan	2001505537
European Patent Office	0944389
Portugal	944389
World Intellectual Property Organization (WIPO)	2005117891
Denmark	1750716