Olumiant is a drug owned by Eli Lilly And Co. It is protected by 6 US drug patents filed from 2021 to 2023 out of which none have expired yet. Olumiant's patents have been open to challenges since 31 May, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 30, 2032. Details of Olumiant's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8158616 | Azetidine and cyclobutane derivatives as JAK inhibitors |
May, 2032
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11045474 | Antiviral JAK inhibitors useful in treating or preventing coronaviridae infections |
Nov, 2032
(6 years from now) | Active |
| US9089574 | Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections |
Nov, 2032
(6 years from now) | Active |
| US9737469 | Methods for treating hair loss disorders |
Nov, 2031
(5 years from now) | Active |
| US11806555 | Methods for treating hair loss disorders |
Nov, 2031
(5 years from now) | Active |
| US8420629 | Azetidine and cyclobutane derivatives as JAK inhibitors |
Mar, 2029
(2 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 Olumiant's patents.
Latest Legal Activities on Olumiant's Patents
Given below is the list of recent legal activities going on the following patents of Olumiant.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Jan, 2025 | US9737469 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Dec, 2024 | US11045474 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Sep, 2024 | US8420629 |
| Patent Term Extension Certificate
Critical | 07 Feb, 2024 | US8158616 |
| 37 CFR 1.750 Request for reconsideration | 18 Jan, 2024 | US8158616 |
| Notice of Final Determination -Eligible | 20 Dec, 2023 | US8158616 |
| FDA Final Eligibility Letter
Critical | 14 Nov, 2023 | US8158616 |
| Patent Issue Date Used in PTA Calculation
Critical | 07 Nov, 2023 | US11806555 |
| Recordation of Patent Grant Mailed
Critical | 07 Nov, 2023 | US11806555 |
| Patent eGrant Notification | 07 Nov, 2023 | US11806555 |
FDA has granted several exclusivities to Olumiant. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Olumiant, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Olumiant.
Exclusivity Information
Olumiant holds 3 exclusivities. All of its exclusivities have expired in 2025. Details of Olumiant's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 31, 2023 |
| New Indication(I-891) | May 10, 2025 |
| New Indication(I-890) | Jun 13, 2025 |
Several oppositions have been filed on Olumiant's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Olumiant's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Olumiant patents.
Olumiant's Oppositions Filed in EPO
Olumiant has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2020, by Concert Pharmaceuticals, Inc.. This opposition was filed on patent number EP11838771A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11838771A | Apr, 2020 | Concert Pharmaceuticals, Inc. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Olumiant 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 Olumiant's family patents as well as insights into
ongoing legal events
on those patents.
Olumiant's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Olumiant:
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:
Olumiant's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 30, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Olumiant Generic API suppliers:
Baricitinib is the generic name for the brand Olumiant. 2 different companies have already filed for the generic of Olumiant, with Msn having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Olumiant's generic
How can I launch a generic of Olumiant before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Olumiant's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Olumiant'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 Olumiant -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 03 Oct, 2023 | 08 Jun, 2030 | Eligible | 08 Aug, 2025 | Less | |
| 31 May, 2022 | 08 Jun, 2030 | Eligible | 22 Jul, 2024 | Less |
Alternative Brands for Olumiant
Olumiant which is used for treating severe alopecia areata, COVID-19 in hospitalized adults requiring supplemental oxygen, ventilation, or ECMO, and rheumatoid arthritis., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Pfizer |
| |||
| Pf Prism Cv |
| |||
About Olumiant
Olumiant is a drug owned by Eli Lilly And Co. It is used for treating severe alopecia areata, COVID-19 in hospitalized adults requiring supplemental oxygen, ventilation, or ECMO, and rheumatoid arthritis. Olumiant uses Baricitinib as an active ingredient. Olumiant was launched by Eli Lilly in 2019.
Approval Date:
Olumiant was approved by FDA for market use on 08 October, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Olumiant is 08 October, 2019, its NCE-1 date is estimated to be 31 May, 2022.
Active Ingredient:
Olumiant uses Baricitinib as the active ingredient. Check out other Drugs and Companies using Baricitinib ingredient
Treatment:
Olumiant is used for treating severe alopecia areata, COVID-19 in hospitalized adults requiring supplemental oxygen, ventilation, or ECMO, and rheumatoid arthritis.
Dosage:
Olumiant is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | TABLET | Prescription | ORAL |
| 4MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |