Acetylcysteine lysine - Generic Drug Details
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What are the generic drug sources for acetylcysteine lysine and what is the scope of patent protection?
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 |
DailyMed Link: | acetylcysteine lysine at DailyMed |
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 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Galephar | LEGUBETI | acetylcysteine lysine | FOR SOLUTION;ORAL | 215040-001 | Feb 13, 2024 | 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 |