JOENJA Drug Patent Profile
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When do Joenja patents expire, and when can generic versions of Joenja launch?
Joenja is a drug marketed by Pharming and is included in one NDA. There is one patent protecting this drug.
This drug has forty-five patent family members in thirty-nine countries.
The generic ingredient in JOENJA is leniolisib phosphate. One supplier is listed for this compound. Additional details are available on the leniolisib phosphate profile page.
DrugPatentWatch® Generic Entry Outlook for Joenja
Joenja will be eligible for patent challenges on March 24, 2027. 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 March 24, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for JOENJA
International Patents: | 45 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 8 |
Drug Prices: | Drug price information for JOENJA |
What excipients (inactive ingredients) are in JOENJA? | JOENJA excipients list |
DailyMed Link: | JOENJA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JOENJA
Generic Entry Date for JOENJA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER 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.
Pharmacology for JOENJA
Anatomical Therapeutic Chemical (ATC) Classes for JOENJA
US Patents and Regulatory Information for JOENJA
JOENJA is protected by one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JOENJA is ⤷ Try a Trial.
This potential generic entry date is based on TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER.
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 JOENJA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting JOENJA
TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharming | JOENJA | leniolisib phosphate | TABLET;ORAL | 217759-001 | Mar 24, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pharming | JOENJA | leniolisib phosphate | TABLET;ORAL | 217759-001 | Mar 24, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pharming | JOENJA | leniolisib phosphate | TABLET;ORAL | 217759-001 | Mar 24, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
International Patents for JOENJA
See the table below for patents covering JOENJA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2012004299 | ⤷ Try a Trial | |
Japan | 2013535411 | ⤷ Try a Trial | |
Eurasian Patent Organization | 201291317 | ТЕТРАГИДРОПИРИДОПИРИМИДИНОВЫЕ ПРОИЗВОДНЫЕ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |