TYLENOL W/ CODEINE NO. 4 Drug Patent Profile
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When do Tylenol W/ Codeine No. 4 patents expire, and what generic alternatives are available?
Tylenol W/ Codeine No. 4 is a drug marketed by Ortho Mcneil Pharm and Janssen Pharms and is included in two NDAs.
The generic ingredient in TYLENOL W/ CODEINE NO. 4 is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tylenol W/ Codeine No. 4
A generic version of TYLENOL W/ CODEINE NO. 4 was approved as acetaminophen; codeine phosphate by SUN PHARM INDS LTD on December 31st, 1969.
Summary for TYLENOL W/ CODEINE NO. 4
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 24 |
| Patent Applications: | 7 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TYLENOL W/ CODEINE NO. 4 at DailyMed |
Recent Clinical Trials for TYLENOL W/ CODEINE NO. 4
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eurofarma Laboratorios S.A. | Phase 3 |
| Humber River Hospital | Phase 4 |
| Blake Raggio | Phase 4 |
Pharmacology for TYLENOL W/ CODEINE NO. 4
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for TYLENOL W/ CODEINE NO. 4
US Patents and Regulatory Information for TYLENOL W/ CODEINE NO. 4
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE NO. 4 | acetaminophen; codeine phosphate | CAPSULE;ORAL | 087421-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Janssen Pharms | TYLENOL W/ CODEINE NO. 4 | acetaminophen; codeine phosphate | TABLET;ORAL | 085055-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
