ACETYLCYSTEINE LYSINE - Generic Drug Details
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What are the generic drug sources for acetylcysteine lysine and what is the scope of freedom to operate?
Acetylcysteine lysine
is the generic ingredient in one branded drug marketed by Galephar and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for ACETYLCYSTEINE LYSINE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Patent Applications: | 190 |
| DailyMed Link: | ACETYLCYSTEINE LYSINE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACETYLCYSTEINE LYSINE
Generic Entry Date for ACETYLCYSTEINE LYSINE*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT 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.
Recent Clinical Trials for ACETYLCYSTEINE LYSINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Joel Lavine | Phase 1/Phase 2 |
| Raptor Pharmaceuticals Corp. | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ACETYLCYSTEINE LYSINE
US Patents and Regulatory Information for ACETYLCYSTEINE LYSINE
| 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 |
