CODEINE SULFATE Drug Patent Profile
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When do Codeine Sulfate patents expire, and when can generic versions of Codeine Sulfate launch?
Codeine Sulfate is a drug marketed by Hikma and Lannett Co Inc and is included in three NDAs.
The generic ingredient in CODEINE SULFATE is codeine sulfate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Codeine Sulfate
A generic version of CODEINE SULFATE was approved as codeine sulfate by HIKMA on July 16th, 2009.
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Questions you can ask:
- What is the 5 year forecast for CODEINE SULFATE?
- What are the global sales for CODEINE SULFATE?
- What is Average Wholesale Price for CODEINE SULFATE?
Summary for CODEINE SULFATE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 8 |
| Patent Applications: | 153 |
| Drug Prices: | Drug price information 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 | 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 | |||
| 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 | |||
| Lannett Co Inc | CODEINE SULFATE | codeine sulfate | TABLET;ORAL | 203046-001 | 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 |
