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Last Updated: November 2, 2024

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.

Drug Prices for ACETYLCYSTEINE

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Recent Clinical Trials for ACETYLCYSTEINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Navamindradhiraj UniversityPhase 3
Xianyang Central Hospital (the second people's Hospital of Xianyang City)N/A
Ankang Central HospitalN/A

See all ACETYLCYSTEINE clinical trials

Generic filers with tentative approvals for ACETYLCYSTEINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up6GM/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.

Medical Subject Heading (MeSH) Categories 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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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.