Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

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Codeine sulfate - Generic Drug Details

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What are the generic drug 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 nineteen 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

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SponsorPhase
Roxane LaboratoriesPhase 3
Quintiles, Inc.Phase 3
Roxane LaboratoriesPhase 1

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Pharmacology for codeine sulfate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for codeine sulfate
Synonyms for codeine sulfate
11QV9BS0CB
1420-53-7
2C18H21NO3.H2O4S
3-Methylmorphine sulfate salt
6854-40-6
7,8-Didehydro-4,5alpha-epoxy-3-methoxy-17-methylmorphinan-6alpha-ol sulfate (2:1) (salt) trihydrate
AVW5HY4N2E
C-56131
CHEMBL284671
Codeine Sulfate (anhydrous)
Codeine sulfate (USP)
Codeine sulfate anhydrous
Codeine sulfate trihydrate
Codeine sulphate
D03580
DTXSID50218658
EINECS 215-818-5
LS-91935
Morphinan-6-alpha-ol, 7,8-didehydro-4,5-alpha-epoxy-3-methoxy-17-methyl-, sulfate (2:1)(salt)
Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5alpha,6alpha)-, sulfate (2:1) (salt)
Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5alpha,6alpha)-, sulfate (2:1) (salt), trihydrate
SCHEMBL24863
SCHEMBL24864
UNII-11QV9BS0CB
UNII-AVW5HY4N2E

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
Lannett Co Inc CODEINE SULFATE codeine sulfate TABLET;ORAL 203046-002 Jun 13, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-003 Jul 16, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-001 Jul 16, 2009 AB RX Yes No   Start Trial   Start Trial   Start 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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Moodys
Merck

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