Ultiva is a drug owned by Mylan Institutional Llc. 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 Mar 10, 2018. Details of Ultiva'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). | |||
|
US5866591 (Pediatric) | Stable formulations of remifentanil |
Mar, 2018
(6 years ago) |
Expired
|
| US5866591 | Stable formulations of remifentanil |
Sep, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ultiva 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 Ultiva's family patents as well as insights into ongoing legal events on those patents.
Ultiva's Family Patents
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Generic Launch
Generic Release Date:
Ultiva's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 10, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ultiva Generic API suppliers:
Remifentanil Hydrochloride is the generic name for the brand Ultiva. 3 different companies have already filed for the generic of Ultiva, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ultiva's generic
How can I launch a generic of Ultiva before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ultiva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ultiva'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 Ultiva -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/vial, 2 mg/vial and 5 mg/vial | 27 Dec, 2013 | 1 | 16 Jan, 2018 | 10 Sep, 2017 | Extinguished |
About Ultiva
Ultiva is a drug owned by Mylan Institutional Llc. Ultiva uses Remifentanil Hydrochloride as an active ingredient. Ultiva was launched by Mylan Institutional in 1996.
Approval Date:
Ultiva was approved by FDA for market use on 12 July, 1996.
Active Ingredient:
Ultiva uses Remifentanil Hydrochloride as the active ingredient. Check out other Drugs and Companies using Remifentanil Hydrochloride ingredient
Dosage:
Ultiva is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE/VIAL | INJECTABLE | Prescription | INJECTION |
| EQ 2MG BASE/VIAL | INJECTABLE | Prescription | INJECTION |
| EQ 5MG BASE/VIAL | INJECTABLE | Prescription | INJECTION |