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Last Updated: November 22, 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, 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, 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
Ankang Central HospitalN/A
Xi'an International Medical Center 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
Rising ACETYLCYSTEINE acetylcysteine INJECTABLE;INTRAVENOUS 203173-001 Mar 24, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Apothecon MUCOMYST acetylcysteine SOLUTION;INHALATION, ORAL 013601-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Roxane ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 072622-001 Sep 30, 1992 DISCN 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

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