Details for New Drug Application (NDA): 208159

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NDA 208159 describes VISTOGARD, which is a drug marketed by Btg Intl and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the VISTOGARD profile page.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the uridine triacetate profile page.

Summary for 208159

Tradename:	VISTOGARD
Applicant:	Btg Intl
Ingredient:	uridine triacetate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208159

Generic Entry Date for 208159^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: GRANULE;ORAL

^*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 NDA: 208159

Ingredient-type	Analogs/Derivatives Pyrimidines

Suppliers and Packaging for NDA: 208159

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VISTOGARD	uridine triacetate	GRANULE;ORAL	208159	NDA	BTG International Inc	50633-220	50633-220-04	4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10)
VISTOGARD	uridine triacetate	GRANULE;ORAL	208159	NDA	BTG International Inc	50633-220	50633-220-20	20 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET (50633-220-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	10GM/PACKET
Approval Date:	Dec 11, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 17, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

Expired US Patents for NDA 208159

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	⤷ Sign Up	⤷ Sign Up
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	⤷ Sign Up	⤷ Sign Up
>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.