Details for New Drug Application (NDA): 022468

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NDA 022468 describes FOLOTYN, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FOLOTYN profile page.

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.

Summary for 022468

Tradename:	FOLOTYN
Applicant:	Acrotech Biopharma
Ingredient:	pralatrexate
Patents:	3
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022468

Suppliers and Packaging for NDA: 022468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468	NDA	Acrotech Biopharma Inc	48818-001	48818-001-01	1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) / 1 mL in 1 VIAL, SINGLE-USE
FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468	NDA	Acrotech Biopharma Inc	48818-001	48818-001-02	1 VIAL, SINGLE-USE in 1 CARTON (48818-001-02) / 2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/ML (20MG/ML)
Approval Date:	Sep 24, 2009	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jul 16, 2022	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
Patent:	⤷ Try a Trial	Patent Expiration:	May 31, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
Patent:	⤷ Try a Trial	Patent Expiration:	May 31, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

Expired US Patents for NDA 022468

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.