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ULTRAM Drug Profile
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Which patents cover Ultram, and what generic alternatives are available?
Ultram is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.
The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ultram
A generic version of ULTRAM was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19th, 2002.
Summary for ULTRAM
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 20 |
| Clinical Trials: | 20 |
| Patent Applications: | 179 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ULTRAM |
| What excipients (inactive ingredients) are in ULTRAM? | ULTRAM excipients list |
| DailyMed Link: | ULTRAM at DailyMed |
Recent Clinical Trials for ULTRAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 2 |
| University of Pennsylvania | Phase 4 |
| Hersh, Elliot V., DMD, MS, PhD | Phase 4 |
Pharmacology for ULTRAM
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for ULTRAM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ULTRAM | TABLET;ORAL | tramadol hydrochloride | 020281 |
US Patents and Regulatory Information for ULTRAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-002 | Mar 3, 1995 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-002 | Sep 8, 2005 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | DISCN | Yes | 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 ULTRAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-002 | Mar 3, 1995 | Start Trial | Start Trial |
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
