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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Covington
US Army
McKesson
Baxter
Accenture
Farmers Insurance
Johnson and Johnson

Generated: August 20, 2018

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

This drug has forty-two patent family members in twenty-one countries.

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.

Drug patent expirations by year for FOLOTYN
Generic Entry Opportunity Date for FOLOTYN
Generic Entry Date for FOLOTYN*:
Constraining patent/regulatory exclusivity:
NDA:
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
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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for FOLOTYN
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 20 mg/mL and 40 mg/2 mL ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for FOLOTYN

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 ➤ Sign Up
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 ➤ Sign Up
7,939,530 Treatment of lymphoma using 10-propargyl-10-deazaaminopterin and gemcitabine ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Colorcon
Teva
AstraZeneca
Queensland Health
US Department of Justice
Cerilliant
Mallinckrodt
Farmers Insurance

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