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ACETAMINOPHEN AND CODEINE PHOSPHATE Drug Profile
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Which patents cover Acetaminophen And Codeine Phosphate, and when can generic versions of Acetaminophen And Codeine Phosphate launch?
Acetaminophen And Codeine Phosphate is a drug marketed by Teva, Aci Healthcare Ltd, Actavis Mid Atlantic, Akorn, Anda Repository, Dava Pharms Inc, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vintage Pharms, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn. and is included in ninety-one NDAs.
The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for ACETAMINOPHEN AND CODEINE PHOSPHATE
| US Patents: | 0 |
| Applicants: | 41 |
| NDAs: | 91 |
| Suppliers / Packagers: | 35 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ACETAMINOPHEN AND CODEINE PHOSPHATE at DailyMed |
Recent Clinical Trials for ACETAMINOPHEN AND CODEINE PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roxane Laboratories | Phase 1 |
Pharmacology for ACETAMINOPHEN AND CODEINE PHOSPHATE
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for ACETAMINOPHEN AND CODEINE PHOSPHATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 085917-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs Florida | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 040443-001 | Jan 22, 2003 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Halsey | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 086549-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Elite Labs Inc | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen; codeine phosphate | TABLET;ORAL | 212418-003 | Sep 10, 2019 | AA | 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 |
