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Last Updated: June 5, 2020

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Details for New Drug Application (NDA): 210557

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NDA 210557 describes VYLEESI (AUTOINJECTOR), which is a drug marketed by Amag Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VYLEESI (AUTOINJECTOR) profile page.

The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. One supplier is listed for this compound. Additional details are available on the bremelanotide acetate profile page.
Summary for 210557
Applicant:Amag Pharms Inc
Ingredient:bremelanotide acetate
Generic Entry Opportunity Date for 210557
Generic Entry Date for 210557*:
Constraining patent/regulatory exclusivity:

*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.

Suppliers and Packaging for NDA: 210557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYLEESI (AUTOINJECTOR) bremelanotide acetate SOLUTION;SUBCUTANEOUS 210557 NDA AMAG Pharmaceuticals, Inc. 64011-701 64011-701-04 4 SYRINGE in 1 CARTON (64011-701-04) > .3 mL in 1 SYRINGE (64011-701-01)
VYLEESI (AUTOINJECTOR) bremelanotide acetate SOLUTION;SUBCUTANEOUS 210557 NDA AMAG Pharmaceuticals, Inc. 64011-701 64011-701-12 2 SYRINGE in 1 CARTON (64011-701-12) > .3 mL in 1 SYRINGE (64011-701-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
Approval Date:Jun 21, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Nov 5, 2033Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 28, 2020Product Flag?YSubstance Flag?YDelist Request?

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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.