Zeposia is a drug owned by Bristol Myers Squibb Co. It is protected by 5 US drug patents filed from 2020 to 2023 out of which none have expired yet. Zeposia's patents have been open to challenges since 25 March, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 30, 2038. Details of Zeposia'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. | |||
| US11680050 | Crystalline forms of ozanimod and ozanimod hydrochloride, and processes for preparation thereof |
Sep, 2038
(13 years from now) | Active |
| US8796318 | Modulators of sphingosine phosphate receptors |
May, 2029
(4 years from now) | Active |
| US8481573 | Modulators of sphingosine phosphate receptors |
May, 2029
(4 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). | |||
| US10239846 | Selective sphingosine 1 phosphate receptor modulators and methods of chiral synthesis |
Nov, 2030
(5 years from now) | Active |
| US9382217 | Modulators of sphingosine phosphate receptors |
May, 2029
(4 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 Zeposia's patents.
Latest Legal Activities on Zeposia's Patents
Given below is the list of recent legal activities going on the following patents of Zeposia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Dec, 2023 | US9382217 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US8481573 |
| transaction for FDA Determination of Regulatory Review Period | 28 Nov, 2023 | US8481573 |
| Recordation of Patent eGrant | 20 Jun, 2023 | US11680050 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Jun, 2023 | US11680050 |
| Recordation of Patent Grant Mailed Critical | 20 Jun, 2023 | US11680050 |
| Email Notification Critical | 20 Jun, 2023 | US11680050 |
| Mail Patent eGrant Notification | 20 Jun, 2023 | US11680050 |
| Electronic Review Critical | 20 Jun, 2023 | US11680050 |
| Patent eGrant Notification | 20 Jun, 2023 | US11680050 |
FDA has granted several exclusivities to Zeposia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zeposia, 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 Zeposia.
Exclusivity Information
Zeposia holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zeposia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-860) | May 27, 2024 |
| New Chemical Entity Exclusivity(NCE) | Mar 25, 2025 |
| M(M-309) | Aug 30, 2027 |
Several oppositions have been filed on Zeposia'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 Zeposia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zeposia patents.
Zeposia's Oppositions Filed in EPO
Zeposia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 14, 2018, by Generics [Uk] Ltd. This opposition was filed on patent number EP10830880A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10830880A | Dec, 2018 | Generics [UK] Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Zeposia 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 Zeposia's family patents as well as insights into ongoing legal events on those patents.
Zeposia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zeposia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 30, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zeposia Generics:
There are no approved generic versions for Zeposia as of now.
Alternative Brands for Zeposia
Zeposia which is used for treating ulcerative colitis and multiple sclerosis in adults., 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 | ||
|---|---|---|---|---|
| Vanda Pharms Inc |
| |||
About Zeposia
Zeposia is a drug owned by Bristol Myers Squibb Co. It is used for treating ulcerative colitis and multiple sclerosis in adults. Zeposia uses Ozanimod Hydrochloride as an active ingredient. Zeposia was launched by Bristol in 2020.
Can you believe Zeposia received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Zeposia was approved by FDA for market use on 25 March, 2020.
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 Zeposia is 25 March, 2020, its NCE-1 date is estimated to be 25 March, 2024.
Active Ingredient:
Zeposia uses Ozanimod Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ozanimod Hydrochloride ingredient
Treatment:
Zeposia is used for treating ulcerative colitis and multiple sclerosis in adults.
Dosage:
Zeposia is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.46MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.92MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.23MG BASE | CAPSULE | Prescription | ORAL |