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DOPTELET Drug Profile
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» See Plans and PricingWhen do Doptelet patents expire, and when can generic versions of Doptelet launch?
Doptelet is a drug marketed by Akarx Inc and is included in one NDA. There are three patents protecting this drug.
This drug has twenty-one patent family members in fourteen countries.
The generic ingredient in DOPTELET is avatrombopag maleate. Additional details are available on the avatrombopag maleate profile page.
US ANDA Litigation and Generic Entry Outlook for Doptelet
Doptelet will be eligible for patent challenges on May 21, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 26, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for DOPTELET
| International Patents: | 21 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 1 |
| Patent Applications: | 31 |
| Drug Prices: | Drug price information for DOPTELET |
| DailyMed Link: | DOPTELET at DailyMed |
Generic Entry Opportunity Date for DOPTELET
Generic Entry Date for DOPTELET*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT NDA:
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.
Recent Clinical Trials for DOPTELET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| Ohio State University Comprehensive Cancer Center | Phase 2 |
US Patents and Regulatory Information for DOPTELET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DOPTELET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1114169 | Start Trial |
| Portugal | 1466912 | Start Trial |
| Japan | WO2003062233 | Start Trial |
| Japan | 4844574 | Start Trial |
| Japan | 2008111001 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DOPTELET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1466912 | 2019C/547 | Belgium | Start Trial | PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624 |
| 1466912 | 122019000107 | Germany | Start Trial | PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620 |
| 1466912 | CA 2019 00057 | Denmark | Start Trial | PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624 |
| 1466912 | 1990057-0 | Sweden | Start Trial | PRODUCT NAME: AVATROMBOPAG, AND PHYSIOLOGICAL SALTS THEREOF, INCLUDING AVATROMBOPAG MALEATE; REG. NO/DATE: EU/1/19/1373 20190624 |
| 1466912 | LUC00137 | Luxembourg | Start Trial | PRODUCT NAME: MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
