LEGUBETI Drug Patent Profile
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 is one drug master file entry 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: | 212 |
| 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 ⤷ Start Trial.
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.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Galephar | LEGUBETI | acetylcysteine lysine | FOR SOLUTION;ORAL | 215040-001 | Feb 13, 2024 | DISCN | Yes | No | ⤷ 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 |
