ACETYLCYSTEINE - Generic Drug Details
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What are the generic sources for acetylcysteine and what is the scope of freedom to operate?
Acetylcysteine
is the generic ingredient in eight branded drugs marketed by Cumberland Pharms, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, Galephar, and Mead Johnson, and is included in thirty NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Acetylcysteine has nineteen patent family members in eleven countries.
There are three drug master file entries for acetylcysteine. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ACETYLCYSTEINE
International Patents: | 19 |
US Patents: | 8 |
Tradenames: | 8 |
Applicants: | 20 |
NDAs: | 30 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 158 |
Clinical Trials: | 400 |
Patent Applications: | 6,686 |
Drug Prices: | Drug price trends 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 |
Xianyang Central Hospital (the second people's Hospital of Xianyang City) | N/A |
Ankang Central Hospital | N/A |
Generic filers with tentative approvals for ACETYLCYSTEINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Steriscience | ACETYLCYSTEINE | acetylcysteine | INJECTABLE;INTRAVENOUS | 217182-001 | Apr 19, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alvogen | ACETYLCYSTEINE | acetylcysteine | SOLUTION;INHALATION, ORAL | 204674-001 | Feb 11, 2014 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Arbor Pharms Llc | CETYLEV | acetylcysteine | TABLET, EFFERVESCENT;ORAL | 207916-002 | Jan 29, 2016 | 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 |
International Patents for ACETYLCYSTEINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20080047398 | ACETYLCYSTEINE COMPOSITION AND USES THEREFOR | ⤷ Sign Up |
Philippines | 12012501687 | ACETYLCYSTEINE COMPOSITION AND USES THEREFOR | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2012012640 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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