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.
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: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 5GM/PACKET | ||||
| Approval Date: | May 18, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,300,087 | Patent Expiration: | Oct 14, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERKALEMIA IN ADULTS | ||||||||
| Patent: | 10,335,432 | Patent Expiration: | Feb 10, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERKALEMIA IN ADULTS | ||||||||
| Patent: | 10,398,730 | Patent Expiration: | Feb 10, 2032 | Product 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 | 207078-001 | May 18, 2018 | 6,332,985 | ⤷ Subscribe |
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | 6,332,985 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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