Details for New Drug Application (NDA): 210238
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NDA 210238 describes DOPTELET, which is a drug marketed by Akarx Inc and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DOPTELET profile page.
The generic ingredient in DOPTELET 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 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 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:
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:
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 | ||||||||
| 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 | ||||||||
| Regulatory Exclusivity Expiration: | Jul 24, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF THROMBOCYTOPENIA IN PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA, WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
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 | ⤷ Start Trial | ⤷ Start Trial |
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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