Leniolisib phosphate - Generic Drug Details
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What are the generic drug sources for leniolisib phosphate and what is the scope of freedom to operate?
Leniolisib phosphate
is the generic ingredient in one branded drug marketed by Pharming and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Leniolisib phosphate has forty-five patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for leniolisib phosphate
| International Patents: | 45 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 8 |
| Patent Applications: | 2 |
| DailyMed Link: | leniolisib phosphate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for leniolisib phosphate
Generic Entry Date for leniolisib phosphate*:
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 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 leniolisib phosphate
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharming | JOENJA | leniolisib phosphate | TABLET;ORAL | 217759-001 | Mar 24, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharming | JOENJA | leniolisib phosphate | TABLET;ORAL | 217759-001 | Mar 24, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 leniolisib phosphate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Guatemala | 201300009 | DERIVADOS DE TETRAHIDRO-PIRIDO-PIRIMIDINA | ⤷ Sign Up |
| European Patent Office | 2590974 | DÉRIVÉS DE TETRAHYDRO-PYRIDO(2,3-D)PYRIMIDINE (TETRAHYDRO-PYRIDO-PYRIMIDINE DERIVATIVES) | ⤷ Sign Up |
| Argentina | 115927 | DERIVADOS DE TETRAHIDRO-PIRIDO-PIRIMIDINA | ⤷ Sign Up |
| Argentina | 118919 | DERIVADOS DE TETRAHIDRO-PIRIDO-PIRIMIDINA | ⤷ Sign Up |
| Colombia | 6670566 | Derivados de tetrahidro- pirido-pirimidina | ⤷ Sign Up |
| Tunisia | 2012000578 | TETRAHYDRO-PYRIDO-PYRIMIDINE DERIVATIVES | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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