Ortikos is a drug owned by Sun Pharmaceutical Industries Inc. It is protected by 2 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 09, 2036. Details of Ortikos'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). | |||
| US10172802 | Oral pharmaceutical dosage forms of budesonide |
Sep, 2036
(9 years from now) | Active |
| US9707182 | Oral pharmaceutical dosage forms of budesonide |
Sep, 2036
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Ortikos's patents.
Latest Legal Activities on Ortikos's Patents
Given below is the list of recent legal activities going on the following patents of Ortikos.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jan, 2025 | US9707182 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Jul, 2022 | US10172802 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Jan, 2021 | US9707182 |
| Recordation of Patent Grant Mailed
Critical | 08 Jan, 2019 | US10172802 |
| Patent Issue Date Used in PTA Calculation
Critical | 08 Jan, 2019 | US10172802 |
| Email Notification
Critical | 20 Dec, 2018 | US10172802 |
| Issue Notification Mailed
Critical | 19 Dec, 2018 | US10172802 |
| Dispatch to FDC | 06 Dec, 2018 | US10172802 |
| Application Is Considered Ready for Issue
Critical | 06 Dec, 2018 | US10172802 |
| Issue Fee Payment Verified
Critical | 04 Dec, 2018 | US10172802 |
US patents provide insights into the exclusivity only within the United States, but
Ortikos 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 Ortikos's family patents as well as insights into
ongoing legal events
on those patents.
Ortikos's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Ortikos:
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:
Ortikos's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 09, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ortikos Generic API suppliers:
Budesonide is the generic name for the brand Ortikos. 22 different companies have already filed for the generic of Ortikos, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ortikos's generic
Alternative Brands for Ortikos
Ortikos which is used for treating mild to moderate active Crohn's disease involving the ileum and/or the ascending colon., has several other brand drugs using the same active ingredient (Budesonide). 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 | |||||
|---|---|---|---|---|---|---|
| Astrazeneca |
| |||||
| Astrazeneca Ab |
| |||||
| Calliditas |
| |||||
| Cheplapharm |
| |||||
| Padagis Us |
| |||||
| Salix |
| |||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Ortikos's active ingredient. Check the complete list of approved generic manufacturers for Ortikos
About Ortikos
Ortikos is a drug owned by Sun Pharmaceutical Industries Inc. It is used for treating mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Ortikos uses Budesonide as an active ingredient. Ortikos was launched by Sun Pharma in 2019.
Approval Date:
Ortikos was approved by FDA for market use on 13 June, 2019.
Active Ingredient:
Ortikos uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Ortikos is used for treating mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.
Dosage:
Ortikos is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 9MG | CAPSULE, DELAYED RELEASE | Discontinued | ORAL |
| 6MG | CAPSULE, DELAYED RELEASE | Discontinued | ORAL |