DOPTELET Drug Patent Profile
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When 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. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.
DrugPatentWatch® Generic Entry Outlook for Doptelet
Doptelet was eligible for patent challenges on May 21, 2022.
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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 45 |
| Clinical Trials: | 7 |
| Patent Applications: | 78 |
| Drug Prices: | Drug price information for DOPTELET |
| What excipients (inactive ingredients) are in DOPTELET? | DOPTELET excipients list |
| DailyMed Link: | DOPTELET at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| Sobi, Inc. | Phase 3 |
| The First Affiliated Hospital of Soochow University | Phase 2/Phase 3 |
| Chinese PLA General Hospital | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for DOPTELET
US Patents and Regulatory Information for DOPTELET
DOPTELET is protected by four US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOPTELET is ⤷ Try a Trial.
This potential generic entry date is based on TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting DOPTELET
2-Acylaminothiazole derivative or salt thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2-acylaminothiazole derivative or salt thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAS HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
2-acylaminothiazole derivative or salt thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE USING DOPTELET
2-acylaminothiazole derivative or salt thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE
FDA Regulatory Exclusivity protecting DOPTELET
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DOPTELET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DOPTELET
See the table below for patents covering DOPTELET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2416304 | ⤷ Try a Trial | |
| South Korea | 20040078122 | ⤷ Try a Trial | |
| Japan | 4844574 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DOPTELET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1466912 | CR 2019 00057 | Denmark | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, I SAERDELESHED AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624 |
| 1466912 | 19C1072 | France | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER L'AVATROMBOPAG MALEATE; NAT. REGISTRATION NO/DATE: EU/1/19/1373 20190624; FIRST REGISTRATION: IE - EU/1/19/1373 20190624 |
| 1466912 | LUC00137 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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