Viewing data from:

OSPHENA

NDA

OSPEMIFENE | N203505 | DUCHESNAY INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

Today

8236861

Aug. 11, 2026

8642079

Jul. 9, 2028

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
Duchesnay Inc. et al v. Hetero Labs Limited et al 1:2021cv00538 1 patentANDA 215574ospemifene	D. Del.	2021-04-14	Terminated 2021-11-17	—

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 Osphena (2023)

Total Spending

$8.5M

Total Claims

16,813

Beneficiaries

4,511

Avg Cost/Unit

$8.44

Spending Trend

$4.6M(2019)→$6.5M(2020)→$7.8M(2021)→$8.1M(2022)→$8.5M(2023)

YoY Change:+0.9%

5yr CAGR:+4.6%

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

API Supply Chain7 active DMFs1 inactive

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

FERMION OYOSPEMIFENE

DMF 255412011

OLON SPAOSPEMIFENE

DMF 297202015

TIANJIN WEIJIE PHARMACEUTICAL CO LTDOSPEMIFENE

DMF 304742016

ALIVUS LIFE SCIENCES LTDOSPEMIFENE

DMF 305742016

HONOUR LAB LTDOSPEMIFENE

DMF 308582016

SHIONOGI INCOSPEMIFENE

DMF 358772021

MAITHRI DRUGS PRIVATE LTDOSPEMIFENE

DMF 386602023

CAMBREX KARLSKOGA ABInactiveOSPEMIFENE

DMF 311632018

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2025	SUPPL -18	View Letter (PDF)
Feb 16, 2024	SUPPL -22	View Letter (PDF)
Feb 13, 2019	SUPPL -15	View Letter (PDF)
Oct 29, 2018	SUPPL -14	View Letter (PDF)
Feb 27, 2015	SUPPL -5	View Letter (PDF)
Feb 28, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG

RLD

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 26, 2013

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8236861	Aug 11, 2026	—	—	—		—
8642079	Jul 9, 2028	—	—	Yes	—	—