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Last Updated: January 20, 2020

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Details for New Drug Application (NDA): 207078

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NDA 207078 describes LOKELMA, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the LOKELMA profile page.

The generic ingredient in LOKELMA is sodium zirconium cyclosilicate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.
Summary for 207078
Tradename:LOKELMA
Applicant:Astrazeneca Pharms
Ingredient:sodium zirconium cyclosilicate
Patents:12
Generic Entry Opportunity Date for 207078
Generic Entry Date for 207078*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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.

Suppliers and Packaging for NDA: 207078
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078 NDA AstraZeneca Pharmaceuticals LP 0310-1105 0310-1105-30 30 PACKET in 1 BOX (0310-1105-30) > 5 g in 1 PACKET (0310-1105-01)
LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078 NDA AstraZeneca Pharmaceuticals LP 0310-1105 0310-1105-39 11 PACKET in 1 BOX (0310-1105-39) > 5 g in 1 PACKET (0310-1105-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength5GM/PACKET
Approval Date:May 18, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 18, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Oct 14, 2035Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERKALEMIA IN ADULTS
Patent:  Start TrialPatent Expiration:Feb 10, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERKALEMIA IN ADULTS

Expired US Patents for NDA 207078

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018   Start Trial   Start Trial
Astrazeneca Pharms LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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