ULTRAM ER Drug Patent Profile
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Which patents cover Ultram Er, and when can generic versions of Ultram Er launch?
Ultram Er is a drug marketed by Valeant Pharms and is included in one NDA.
The generic ingredient in ULTRAM ER is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ultram Er
A generic version of ULTRAM ER was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19th, 2002.
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Summary for ULTRAM ER
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Clinical Trials: | 21 |
| Patent Applications: | 2,368 |
| What excipients (inactive ingredients) are in ULTRAM ER? | ULTRAM ER excipients list |
| DailyMed Link: | ULTRAM ER at DailyMed |
Recent Clinical Trials for ULTRAM ER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| Medical College of Wisconsin | Phase 2 |
| Hersh, Elliot V., DMD, MS, PhD | Phase 4 |
Paragraph IV (Patent) Challenges for ULTRAM ER
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ULTRAM ER | Extended-release Tablets | tramadol hydrochloride | 300 mg | 021692 | 1 | 2007-09-25 |
| ULTRAM ER | Extended-release Tablets | tramadol hydrochloride | 200 mg | 021692 | 1 | 2007-03-28 |
| ULTRAM ER | Extended-release Tablets | tramadol hydrochloride | 100 mg | 021692 | 1 | 2007-01-08 |
US Patents and Regulatory Information for ULTRAM ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-002 | Sep 8, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-003 | Sep 8, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-002 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-002 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-003 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-003 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ULTRAM ER
See the table below for patents covering ULTRAM ER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Finland | 20030560 | ⤷ Sign Up | |
| Norway | 944473 | ⤷ Sign Up | |
| Denmark | 0630646 | ⤷ Sign Up | |
| Japan | 3280810 | ⤷ Sign Up | |
| Hungary | 9402007 | ⤷ Sign Up | |
| China | 1230154 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ULTRAM ER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0566709 | C300152 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405 |
| 0566709 | SPC/GB04/012 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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