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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 207078


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NDA 207078 describes LOKELMA, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from two suppliers. There are fourteen 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. Two suppliers are listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.
Summary for 207078
Tradename:LOKELMA
Applicant:Astrazeneca
Ingredient:sodium zirconium cyclosilicate
Patents:14
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Patent:⤷  Try a TrialPatent Expiration:Oct 14, 2035Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERKALEMIA IN ADULTS
Patent:⤷  Try a TrialPatent Expiration:Feb 10, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERKALEMIA IN ADULTS
Patent:⤷  Try a 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 LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-001 May 18, 2018 ⤷  Try a Trial ⤷  Try a Trial
>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.