Codeine sulfate - Generic Drug Details
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What are the generic sources for codeine sulfate and what is the scope of freedom to operate?
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 |
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 |
Pharmacology for codeine sulfate
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for codeine sulfate
Anatomical Therapeutic Chemical (ATC) Classes 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 | TABLET;ORAL | 022402-003 | Jul 16, 2009 | AB | RX | Yes | Yes | ⤷ 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 | |||
| 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 | |||
| Hikma | CODEINE SULFATE | codeine sulfate | SOLUTION;ORAL | 202245-001 | Jun 30, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lannett Co Inc | CODEINE SULFATE | codeine sulfate | TABLET;ORAL | 203046-003 | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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