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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209128

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NDA 209128 describes DSUVIA, which is a drug marketed by Acelrx Pharms and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the DSUVIA profile page.

The generic ingredient in DSUVIA is sufentanil citrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.
Summary for 209128
Tradename:DSUVIA
Applicant:Acelrx Pharms
Ingredient:sufentanil citrate
Patents:16
Formulation / Manufacturing:see details
Pharmacology for NDA: 209128
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 209128
Suppliers and Packaging for NDA: 209128
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128 NDA AcelRx Pharmaceuticals, Inc 61621-430 61621-430-01 1 TABLET in 1 POUCH (61621-430-01)
DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128 NDA AcelRx Pharmaceuticals, Inc 61621-430 61621-430-11 10 TABLET in 1 CARTON (61621-430-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 0.03MG BASE
Approval Date:Nov 2, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 2, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jan 5, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE PAIN
Patent:  Start TrialPatent Expiration:Jan 5, 2027Product Flag?YSubstance Flag?Delist Request?

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