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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205739

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NDA 205739 describes VELTASSA, which is a drug marketed by Relypsa Inc and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the VELTASSA profile page.

The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.
Summary for 205739
Applicant:Relypsa Inc
Ingredient:patiromer sorbitex calcium
Generic Entry Opportunity Date for 205739
Generic Entry Date for 205739*:
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.

Pharmacology for NDA: 205739
Suppliers and Packaging for NDA: 205739
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739 NDA Relypsa, Inc. 53436-084 53436-084-04 4 PACKET in 1 CARTON (53436-084-04) > 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-01)
VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739 NDA Relypsa, Inc. 53436-084 53436-084-30 30 PACKET in 1 CARTON (53436-084-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 8.4GM BASE/PACKET
Approval Date:Oct 21, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 21, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Feb 27, 2025Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 11, 2026Product Flag?YSubstance Flag?Delist Request?

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