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Last Updated: April 4, 2026

CODEINE Drug Patent Profile

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Which patents cover Codeine, and when can generic versions of Codeine launch?

Codeine is a drug marketed by Hikma, Lannett Co Inc, and Scherer Labs. and is included in six NDAs.

The generic ingredient in CODEINE is acetaminophen; aspirin; codeine phosphate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; aspirin; codeine phosphate profile page.

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Summary for CODEINE

US Patents:	0
Applicants:	3
NDAs:	6
Drug Prices:	Drug price information for CODEINE
DailyMed Link:	CODEINE at DailyMed

Drug patent expirations by year for CODEINE

Drug Prices for CODEINE

US Patents and Regulatory Information for CODEINE

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lannett Co Inc	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	203046-003	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
Scherer Labs	CODEINE, ASPIRIN, APAP FORMULA NO. 2	acetaminophen; aspirin; codeine phosphate	CAPSULE;ORAL	085640-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ 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
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-002	Jul 16, 2009	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lannett Co Inc	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	203046-002	Jun 13, 2014	AB	RX	No	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

DrugChatter Q&A for CODEINE

Is there is 960mg of codeine im my cough syrup then wouldn 039 t that equate to 32 pills of 30mg codeine or would it be more i thought they crushed them up and put them in the syrup?
Can tramdol be replaced by codeine for cough syrup?
Okay so if heating codeine above 120 f to 130 is the killer for it then what temp is best for water solubility this is based off us just talking about this science?
Hi what is the consistency of codeine cough syrup suppose to be like maple syrup honey watery?
I 039 m confused by my cough syrup it says 960mg of codeine does that mean they took 32 codeine pills and put that into the bottle?

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