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TYLENOL Drug Profile
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Which patents cover Tylenol, and what generic alternatives are available?
Tylenol is a drug marketed by J And J Consumer Inc, Ortho Mcneil Pharm, and Janssen Pharms. and is included in seven NDAs.
The generic ingredient in TYLENOL is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for TYLENOL
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 7 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 138 |
| Clinical Trials: | 253 |
| Patent Applications: | 7,952 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for TYLENOL |
| DailyMed Link: | TYLENOL at DailyMed |
Recent Clinical Trials for TYLENOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| State University of New York at Buffalo | Phase 3 |
| National Institutes of Health (NIH) | Phase 2 |
| Tufts Medical Center | Phase 2 |
Paragraph IV (Patent) Challenges for TYLENOL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TYLENOL | TABLET, EXTENDED RELEASE;ORAL | acetaminophen | 019872 |
US Patents and Regulatory Information for TYLENOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | TYLENOL | acetaminophen | SUPPOSITORY;RECTAL | 017756-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE | acetaminophen; codeine phosphate | TABLET;ORAL | 085056-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-002 | Jan 11, 2001 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE NO. 3 | acetaminophen; codeine phosphate | CAPSULE;ORAL | 087422-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ortho Mcneil Pharm | TYLENOL W/ CODEINE | acetaminophen; codeine phosphate | TABLET;ORAL | 085056-003 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
Expired US Patents for TYLENOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | Start Trial | Start Trial |
| J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | Start Trial | Start Trial |
| J And J Consumer Inc | TYLENOL | acetaminophen | TABLET, EXTENDED RELEASE;ORAL | 019872-001 | Jun 8, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TYLENOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Greece | 880100491 | Start Trial |
| New Zealand | 225402 | Start Trial |
| Japan | S6440424 | Start Trial |
| Hong Kong | 87893 | Start Trial |
| South Africa | 8805460 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
