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. Sixteen 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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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: | 3,592 |
| 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 |
|---|---|
| Shandong Provincial Hospital | Phase 1 |
| Central South University | Phase 1 |
| University of Missouri-Columbia | 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Acetylcysteine composition and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Acetylcysteine composition and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Acetycysteine compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
Acetylcysteine compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cumberland Pharms | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 ACETADOTE
See the table below for patents covering ACETADOTE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2009506030 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2007024311 | ⤷ Sign Up | |
| Philippines | 12012501687 | ACETYLCYSTEINE COMPOSITION AND USES THEREFOR | ⤷ Sign Up |
| South Korea | 101408336 | ⤷ Sign Up | |
| Malaysia | 173215 | ACETYLCYSTEINE COMPOSITIONS AND METHODS OF USE THEREOF | ⤷ Sign Up |
| Australia | 2011281035 | Acetycysteine compositions and methods of use thereof | ⤷ Sign Up |
| New Zealand | 566100 | Acetylcysteine composition and uses therefor | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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