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.

Summary for CODEINE SULFATE

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	8
Patent Applications:	1,721
Drug Prices:	Drug price trends for CODEINE SULFATE
What excipients (inactive ingredients) are in CODEINE SULFATE?	CODEINE SULFATE excipients list
DailyMed Link:	CODEINE SULFATE at DailyMed

See drug prices for CODEINE SULFATE

Recent Clinical Trials for CODEINE SULFATE

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

Sponsor	Phase
University of Sao Paulo General Hospital	Phase 3
Aristotle University Of Thessaloniki	Phase 4
Roxane Laboratories	Phase 3

See all CODEINE SULFATE clinical trials

Pharmacology for CODEINE SULFATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for CODEINE SULFATE

Analgesics, Opioid
Antitussive Agents
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for CODEINE SULFATE

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for CODEINE SULFATE

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Glossary

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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	TABLET;ORAL	022402-001	Jul 16, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-002	Jul 16, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	203046-002	Jun 13, 2014	AB	RX	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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