ACETADOTE Drug Patent Profile
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Which patents cover Acetadote, and what generic alternatives are available?
Acetadote is a drug marketed by Cumberland Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has eighteen patent family members in eleven countries.
The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Acetadote
A generic version of ACETADOTE was approved as acetylcysteine by HOSPIRA on August 30th, 1994.
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Questions you can ask:
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Summary for ACETADOTE
International Patents: | 18 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 158 |
Clinical Trials: | 14 |
Patent Applications: | 2,031 |
Drug Prices: | Drug price information for ACETADOTE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACETADOTE |
What excipients (inactive ingredients) are in ACETADOTE? | ACETADOTE excipients list |
DailyMed Link: | ACETADOTE at DailyMed |
Recent Clinical Trials for ACETADOTE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Missouri-Columbia | Phase 1 |
Shandong Provincial Hospital | Phase 1 |
Central South University | Phase 1 |
Pharmacology for ACETADOTE
Drug Class | Antidote Antidote for Acetaminophen Overdose Mucolytic |
Mechanism of Action | Reduction Activity |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration |
Paragraph IV (Patent) Challenges for ACETADOTE
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 ACETADOTE
ACETADOTE is protected by five US patents.
Patents protecting ACETADOTE
Acetylcysteine composition and uses therefor
Patent Number: 8,148,356
Patent Expiration: ⤷ Subscribe
Acetylcysteine composition and uses thereof
Patent Number: 8,399,445
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Acetylcysteine composition and uses thereof
Patent Number: 8,653,061
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Acetycysteine compositions and methods of use thereof
Patent Number: 8,722,738
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Acetylcysteine compositions and methods of use thereof
Patent Number: 9,327,028
Patent Expiration: ⤷ Subscribe
Patented Use: COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | 8,399,445 | ⤷ Subscribe | ⤷ Subscribe | |||
Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | 8,722,738 | ⤷ Subscribe | ⤷ Subscribe | |||
Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | 9,327,028 | ⤷ Subscribe | ⤷ Subscribe | |||
>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 ACETADOTE
See the table below for patents covering ACETADOTE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101408336 | ⤷ Subscribe | |
New Zealand | 566100 | Acetylcysteine composition and uses therefor | ⤷ Subscribe |
Japan | 2009506030 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |