➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Boehringer Ingelheim

Last Updated: June 22, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020281

Email this page to a colleague

« Back to Dashboard

NDA 020281 describes ULTRAM, which is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the ULTRAM profile page.

The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for 020281
Applicant:Janssen Pharms
Ingredient:tramadol hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 020281
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 020281
Suppliers and Packaging for NDA: 020281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAM tramadol hydrochloride TABLET;ORAL 020281 NDA Janssen Pharmaceuticals, Inc. 50458-659 50458-659-60 100 TABLET, COATED in 1 BOTTLE (50458-659-60)
Paragraph IV (Patent) Challenges for 020281
Tradename Dosage Ingredient NDA Submissiondate
ULTRAM TABLET;ORAL tramadol hydrochloride 020281

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Mar 3, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020281

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-001 Mar 3, 1995   Try Before You Buy   Try Before You Buy
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-002 Mar 3, 1995   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim

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.