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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Questions you can ask:
- What is the 5 year forecast for ULTRAM ER?
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- What is Average Wholesale Price for ULTRAM ER?
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 |
Bayer | 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 | 021692-001 | 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 |
>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 |
---|---|---|---|
Japan | H07138189 | RELEASE CONTROL PREPARATION COATED WITH ETHYL CELLULOSE AQUEOUS DISPERSION | ⤷ Sign Up |
European Patent Office | 0647448 | ⤷ Sign Up | |
Greece | 3036565 | ⤷ 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 |