Details for New Drug Application (NDA): 219696
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NDA 219696 describes DOPTELET SPRINKLE, which is a drug marketed by Akarx Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DOPTELET SPRINKLE profile page.
The generic ingredient in DOPTELET SPRINKLE is avatrombopag maleate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.
The generic ingredient in DOPTELET SPRINKLE is avatrombopag maleate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.
Summary for 219696
| Tradename: | DOPTELET SPRINKLE |
| Applicant: | Akarx Inc |
| Ingredient: | avatrombopag maleate |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219696
Generic Entry Date for 219696*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THROMBOCYTOPENIA IN PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT Dosage:
GRANULE;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: 219696
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOPTELET SPRINKLE | avatrombopag maleate | GRANULE;ORAL | 219696 | NDA | AkaRx, Inc. | 71369-010 | 71369-010-30 | 1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 24, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 24, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jul 24, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF THROMBOCYTOPENIA IN PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 28, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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