FOLOTYN Drug Patent Profile

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

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

This drug has thirty-one 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.

DrugPatentWatch^® 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 May 31, 2025. 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:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	23
Patent Applications:	4,034
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FOLOTYN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOLOTYN
What excipients (inactive ingredients) are in FOLOTYN?	FOLOTYN excipients list
DailyMed Link:	FOLOTYN at DailyMed

See drug prices for FOLOTYN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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
Columbia University	Phase 3
Jennifer Amengual	Phase 3

See all FOLOTYN clinical trials

Pharmacology for FOLOTYN

Drug Class

Folate Analog Metabolic Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for FOLOTYN

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for FOLOTYN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOLOTYN	Injection	pralatrexate	20 mg/mL and 40 mg/2 mL	022468	4	2013-09-24

US Patents and Regulatory Information for FOLOTYN

FOLOTYN is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FOLOTYN

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

Expired US Patents for FOLOTYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009

EU/EMA Drug Approvals for FOLOTYN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Allos Therapeutics Ltd	Folotyn	pralatrexate	EMEA/H/C/002096 treatment of peripheral T-cell lymphoma,	Refused	no	no	yes		2012-06-21

International Patents for FOLOTYN

When does loss-of-exclusivity occur for FOLOTYN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Germany

Hong Kong

Japan

Mexico

Montenegro

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FOLOTYN around the world.

Country	Patent Number	Title	Estimated Expiration
Montenegro	01087	TRETMAN LIMFOMA T-ĆELIJA PRIMJENOM 10-PROPARGIL-10-DEAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN)
Serbia	50622	TRETMAN LIMFOMA T-ĆELIJA PRIMENOM 10-PROPARGIL-10-DIAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN)
Spain	2313737
Austria	405272
European Patent Office	1750716	TRAITEMENT DU LYMPHOME T UTILISANT 10-PROPARGYL-10-DEAZAAMINOPTERINE (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN)
South Korea	20070035490	Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Brazil	PI0510895	formulação farmacêutica de 10-propargila-10-deazaaminopterina para tratamento de linfoma de célula t