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Last Updated: October 20, 2021

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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-two suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for ULTRAM ER
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 72
Clinical Trials: 20
Patent Applications: 1,683
Formulation / Manufacturing:see details
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
Medical College of WisconsinPhase 2
Hersh, Elliot V., DMD, MS, PhDPhase 4
BayerPhase 4

See all ULTRAM ER clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ULTRAM ER
Paragraph IV (Patent) Challenges for ULTRAM ER
Tradename Dosage Ingredient NDA Submissiondate
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-09-25
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-03-28
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ULTRAM ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0566709 SPC/GB04/012 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709 C300152 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Moodys
AstraZeneca
Harvard Business School
Medtronic

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