Zeposia Patent Expiration

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

(6 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.

Given below is the list of recent legal activities going on the following patents of Zeposia.

Activity Date Patent Number
Patent litigations
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 20 Jun, 2023 US11680050
Recordation of Patent Grant Mailed 20 Jun, 2023 US11680050
Email Notification 20 Jun, 2023 US11680050
Mail Patent eGrant Notification 20 Jun, 2023 US11680050
Electronic Review 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 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. 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

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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
Patent litigations
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

Zeposia has patent protection in a total of 31 countries. It's US patent count contributes only to 18.6% of its total global patent coverage. Click below to unlock the full patent family tree for Zeposia.

Family Patents

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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
Ponvory used for reducing circulating lymphocytes in treating relapsing forms of multiple sclerosis in adults.





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