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 Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane. and is included in twenty-three NDAs.
The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Sixteen 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.
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Summary for ACETYLCYSTEINE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 158 |
| Clinical Trials: | 400 |
| Patent Applications: | 278 |
| 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 |
|---|---|
| Navamindradhiraj University | Phase 3 |
| The First Affiliated Hospital of ShiheziI University | N/A |
| Xianyang Central Hospital (the second people's Hospital of Xianyang City) | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 207358-001 | Feb 29, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 071365-001 | May 1, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sagent Pharms Inc | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 091684-001 | Oct 31, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Inc | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 213693-001 | Feb 3, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alvogen | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 203853-001 | Jun 21, 2012 | AN | RX | No | 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 |
