ACETYLCYSTEINE Drug Patent Profile
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Which patents cover Acetylcysteine, and when can generic versions of Acetylcysteine launch?
Acetylcysteine is a drug marketed by Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane. and is included in twenty-two NDAs.
The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Acetylcysteine
A generic version of ACETYLCYSTEINE was approved as acetylcysteine by HOSPIRA on August 30th, 1994.
Summary for ACETYLCYSTEINE
US Patents: | 0 |
Applicants: | 13 |
NDAs: | 22 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 158 |
Clinical Trials: | 395 |
Patent Applications: | 3,661 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ACETYLCYSTEINE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACETYLCYSTEINE |
What excipients (inactive ingredients) are in ACETYLCYSTEINE? | ACETYLCYSTEINE excipients list |
DailyMed Link: | ACETYLCYSTEINE at DailyMed |
Recent Clinical Trials for ACETYLCYSTEINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Alabama at Birmingham | Early Phase 1 |
Sanjay Gandhi Postgraduate Institute of Medical Sciences | Phase 3 |
Assiut University | Phase 1 |
Pharmacology for ACETYLCYSTEINE
Drug Class | Antidote Antidote for Acetaminophen Overdose Mucolytic |
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Medical Subject Heading (MeSH) Categories for ACETYLCYSTEINE
Anatomical Therapeutic Chemical (ATC) Classes for ACETYLCYSTEINE
Paragraph IV (Patent) Challenges for ACETYLCYSTEINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACETADOTE | Injection | acetylcysteine | 200 mg/mL, 30 mL vials | 021539 | 3 | 2012-04-04 |
US Patents and Regulatory Information for ACETYLCYSTEINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aspen | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 213693-001 | Feb 3, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hospira | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 074037-001 | Aug 30, 1994 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sagent Pharms Inc | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 091684-001 | Oct 31, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Fresenius Kabi Usa | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 200644-001 | Nov 7, 2012 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Am Regent | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 072489-001 | Jul 28, 1995 | AN | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Roxane | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 072621-001 | Sep 30, 1992 | DISCN | No | No | ⤷ 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 |