Sporanox is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 3 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 Jun 18, 2019. Details of Sporanox'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). | |||
| US6407079 | Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation |
Jun, 2019
(7 years ago) |
Expired
|
| US5707975 | Oral formulations on an antifungal |
Jan, 2015
(11 years ago) |
Expired
|
| US5633015 | Beads having a core coated with an antifungal and a polymer |
May, 2014
(12 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Sporanox and ongoing
litigations to
help you estimate the early arrival of Sporanox generic.
Sporanox's Litigations
Sporanox been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 05, 2000, against patent number US6407079. The petitioner , challenged the validity of this patent, with PITHA V. MULLER as the respondent. Click below to track the latest information on how companies are challenging Sporanox's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6407079 | October, 2000 |
Decision
(05 Oct, 2000) | PITHA V. MULLER | |
US patents provide insights into the exclusivity only within the United States, but
Sporanox 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 Sporanox's family patents as well as insights into
ongoing legal events
on those patents.
Sporanox's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Sporanox:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Sporanox's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 18, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sporanox Generic API suppliers:
Itraconazole is the generic name for the brand Sporanox. 13 different companies have already filed for the generic of Sporanox, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sporanox's generic
How can I launch a generic of Sporanox before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sporanox's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sporanox'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 Sporanox -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None | |||||
| 03 May, 2013 | 18 Jun, 2019 | Eligible | 30 Oct, 2015 | Less |
Alternative Brands for Sporanox
There are several other brand drugs using the same active ingredient (Itraconazole) as Sporanox. 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Itraconazole, Sporanox's active ingredient. Check the complete list of approved generic manufacturers for Sporanox
About Sporanox
Sporanox is a drug owned by Janssen Pharmaceuticals Inc. Sporanox uses Itraconazole as an active ingredient. Sporanox was launched by Janssen in 1999.
Approval Date:
Sporanox was approved by FDA for market use on 30 March, 1999.
Active Ingredient:
Sporanox uses Itraconazole as the active ingredient. Check out other Drugs and Companies using Itraconazole ingredient
Dosage:
Sporanox is available in the following dosage forms - capsule form for oral use, solution form for oral use, injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/ML | INJECTABLE | Discontinued | INJECTION |
| 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |