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ZEPOSIA

NDA

OZANIMOD HYDROCHLORIDE | N209899 | BRISTOL MYERS SQUIBB CO

3 strengths5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Mar. 24, 2033

May. 14, 2029

May. 14, 2029

Nov. 15, 2030

Sep. 30, 2038

M-309

Aug. 30, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Company et al v. Synthon BV 1:2024cv00780 5 patentsANDA 219236ozanimod	D. Del.	2024-07-02	Terminated 2025-09-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Zeposia (2023)

Total Spending

$62.9M

Total Claims

6,180

Beneficiaries

1,034

Avg Cost/Unit

$294.31

Spending Trend

$2.1M(2020)→$19.6M(2021)→$37.8M(2022)→$62.9M(2023)

YoY Change:+8.7%

5yr CAGR:+6.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MAITHRI DRUGS PRIVATE LTDOZANIMOD HYDROCHLORIDE

DMF 370152022

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDOZANIMOD HYDROCHLORIDE

DMF 375972022

MAPRIMED SAOZANIMOD HYDROCHLORIDE

DMF 386222023

SYNTHON BVOZANIMOD HYDROCHLORIDE

DMF 386682023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Sep 3, 2024	SUPPL -11	View Letter (PDF)
Sep 3, 2024	SUPPL -12	View Letter (PDF)
Jul 2, 2024	SUPPL -13	View Letter (PDF)
Jul 2, 2024	SUPPL -14	View Letter (PDF)
Sep 30, 2022	SUPPL -5	View Letter (PDF)
Dec 21, 2021	SUPPL -3	View Letter (PDF)
Jun 1, 2021	SUPPL -1	View Letter (PDF)
Mar 26, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.23MG BASE

RLD

5 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Mar 25, 2020

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8481573	Mar 24, 2033	—	Yes	Yes		—
8796318	May 14, 2029	—	Yes	Yes	—	—
9382217	May 14, 2029	—	—	—		—
10239846	Nov 15, 2030	—	—	—		—
11680050	Sep 30, 2038	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
M-309	Aug 30, 2027	Active

#002 — EQ 0.46MG BASE

RLD

5 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Mar 25, 2020

#003 — EQ 0.92MG BASE

RLD

5 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Mar 25, 2020