ULTRAM Drug Patent 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.
The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-two 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: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 20 |
| Patent Applications: | 134 |
| 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 |
| Hersh, Elliot V., DMD, MS, PhD | Phase 4 |
| University of Pennsylvania | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ULTRAM
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-002 | Sep 8, 2005 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | 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 |
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 | See Plans and Pricing | See Plans and Pricing |
| Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
