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Last Updated: November 21, 2024

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
Drug patent expirations by year for ULTRAM ER
Recent Clinical Trials for ULTRAM ER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Henry Ford Health SystemPhase 4
Medical College of WisconsinPhase 2
BayerPhase 4

See all ULTRAM ER clinical trials

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

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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.