LEGUBETI Drug Patent Profile
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When do Legubeti patents expire, and when can generic versions of Legubeti launch?
Legubeti is a drug marketed by Galephar and is included in one NDA.
The generic ingredient in LEGUBETI is acetylcysteine lysine. There are three drug master file entries for this compound. Additional details are available on the acetylcysteine lysine profile page.
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Summary for LEGUBETI
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Patent Applications: | 122 |
DailyMed Link: | LEGUBETI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEGUBETI
Generic Entry Date for LEGUBETI*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT NDA:
Dosage:
FOR SOLUTION;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.
US Patents and Regulatory Information for LEGUBETI
LEGUBETI is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEGUBETI is ⤷ Sign Up.
This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting LEGUBETI
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galephar | LEGUBETI | acetylcysteine lysine | FOR SOLUTION;ORAL | 215040-002 | Feb 13, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galephar | LEGUBETI | acetylcysteine lysine | FOR SOLUTION;ORAL | 215040-001 | Feb 13, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |