Viewing data from:

ODOMZO

NDA

SONIDEGIB PHOSPHATE | N205266 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

8063043

Sep. 15, 2029

8178563

Jul. 24, 2029

10266523

Mar. 30, 2036

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Odomzo (2023)

Total Spending

$29.3M

Total Claims

2,200

Beneficiaries

495

Avg Cost/Unit

$464.61

Spending Trend

$17.4M(2019)→$23.6M(2020)→$26.8M(2021)→$24.4M(2022)→$29.3M(2023)

YoY Change:+5.7%

5yr CAGR:+4.8%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDSONIDEGIB PHOSPHATE

DMF 313882017

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Aug 23, 2023	SUPPL -9	View Letter (PDF)
May 15, 2019	SUPPL -6	View Letter (PDF)
Sep 22, 2017	SUPPL -4	View Letter (PDF)
May 16, 2016	SUPPL -2	View Letter (PDF)
Jul 24, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 200MG BASE

RLD

3 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 24, 2015

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8063043	Sep 15, 2029	—	Yes	Yes	—	—
8178563	Jul 24, 2029	—	Yes	—		—
10266523	Mar 30, 2036	—	Yes	Yes	—	—