Ultram is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 12, 2020. Details of Ultram's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6339105 (Pediatric) | Analgesic regimen |
Apr, 2020
(4 years ago) |
Expired
|
| US6339105 | Analgesic regimen |
Oct, 2019
(5 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ultram is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ultram's family patents as well as insights into ongoing legal events on those patents.
Ultram's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ultram's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 12, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ultram Generic API suppliers:
Tramadol Hydrochloride is the generic name for the brand Ultram. 28 different companies have already filed for the generic of Ultram, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ultram's generic
How can I launch a generic of Ultram before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ultram's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ultram's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ultram -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg |
Alternative Brands for Ultram
Ultram which is used for managing pain with a titration dosing regimen starting at 25mg., has several other brand drugs using the same active ingredient (Tramadol Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Athena |
| |
| Cipher Pharms Inc |
| |
| Kowa Pharms |
| |
| Purdue Pharma |
| |
| Shionogi Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tramadol Hydrochloride, Ultram's active ingredient. Check the complete list of approved generic manufacturers for Ultram
About Ultram
Ultram is a drug owned by Janssen Pharmaceuticals Inc. It is used for managing pain with a titration dosing regimen starting at 25mg. Ultram uses Tramadol Hydrochloride as an active ingredient. Ultram was launched by Janssen Pharms in 1995.
Approval Date:
Ultram was approved by FDA for market use on 03 March, 1995.
Active Ingredient:
Ultram uses Tramadol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tramadol Hydrochloride ingredient
Treatment:
Ultram is used for managing pain with a titration dosing regimen starting at 25mg.
Dosage:
Ultram is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |