Pralatrexate - Generic Drug Details

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What are the generic drug sources for pralatrexate and what is the scope of freedom to operate?

Pralatrexate is the generic ingredient in one branded drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pralatrexate has thirty-one patent family members in twenty-three countries.

There are two drug master file entries for pralatrexate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for pralatrexate

International Patents:	31
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	39
Patent Applications:	6,567
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pralatrexate
What excipients (inactive ingredients) are in pralatrexate?	pralatrexate excipients list
DailyMed Link:	pralatrexate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pralatrexate

Generic Entry Date for pralatrexate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 pralatrexate

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

Sponsor	Phase
Acrotech Biopharma Inc.	Phase 3
Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 1
University of Bologna	Phase 1

See all pralatrexate clinical trials

Generic filers with tentative approvals for PRALATREXATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG/2ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	20MG/1ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pralatrexate

Drug Class	Folate Analog Metabolic Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for pralatrexate

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

Paragraph IV (Patent) Challenges for PRALATREXATE

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 pralatrexate

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acrotech Biopharma	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

Expired US Patents for pralatrexate

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

EU/EMA Drug Approvals for pralatrexate

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for pralatrexate

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Country	Patent Number	Title	Estimated Expiration
Germany	602005009176		⤷ Sign Up
China	1960734	Treatment of t-cell lymphoma using 10-propargyl-10-deazaaminopterin	⤷ Sign Up
Australia	2005249516	Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin	⤷ Sign Up
South Korea	101189692		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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