Details for New Drug Application (NDA): 210238
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The generic ingredient in DOPTELET is avatrombopag maleate. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.
Summary for 210238
Tradename: | DOPTELET |
Applicant: | Akarx Inc |
Ingredient: | avatrombopag maleate |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210238
Generic Entry Date for 210238*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 210238
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238 | NDA | AkaRx, Inc. | 71369-020 | 71369-020-10 | 1 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11) |
DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238 | NDA | AkaRx, Inc. | 71369-020 | 71369-020-15 | 1 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | May 21, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 26, 2026 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Jul 28, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 210238
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | ⤷ Subscribe | ⤷ Subscribe |
Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | ⤷ Subscribe | ⤷ Subscribe |
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