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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 twelve 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.
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
| Tradename: | VELTASSA |
| Applicant: | Relypsa Inc |
| Ingredient: | patiromer sorbitex calcium |
| Patents: | 12 |
Generic Entry Opportunity Date for 205739
Generic Entry Date for 205739*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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.
Pharmacology for NDA: 205739
| Mechanism of Action | Potassium Ion Binding Activity |
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) |
Paragraph IV (Patent) Challenges for 205739
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VELTASSA | POWDER;ORAL | patiromer sorbitex calcium | 205739 | 2019-10-21 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 8.4GM BASE/PACKET | ||||
| Approval Date: | Oct 21, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 21, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Mar 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERKALEMIA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 27, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERKALEMIA | ||||||||
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