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Last Updated: March 29, 2024

CODEINE SULFATE - Generic Drug Details


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What are the generic sources for codeine sulfate and what is the scope of patent protection?

Codeine sulfate is the generic ingredient in one branded drug marketed by Hikma and Lannett Co Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for codeine sulfate. Two suppliers are listed for this compound.

Drug Prices for CODEINE SULFATE

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Recent Clinical Trials for CODEINE SULFATE

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

SponsorPhase
University of Sao Paulo General HospitalPhase 3
Aristotle University Of ThessalonikiPhase 4
Roxane LaboratoriesPhase 3

See all CODEINE SULFATE clinical trials

Pharmacology for CODEINE SULFATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for CODEINE SULFATE

US Patents and Regulatory Information for CODEINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CODEINE SULFATE codeine sulfate SOLUTION;ORAL 202245-001 Jun 30, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc CODEINE SULFATE codeine sulfate TABLET;ORAL 203046-002 Jun 13, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-003 Jul 16, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-001 Jul 16, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc CODEINE SULFATE codeine sulfate TABLET;ORAL 203046-001 Jun 13, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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