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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Duchesnay Inc. et al v. Hetero Labs Limited et al 1:2021cv01130	D. Del.	2021-08-03	Terminated 2021-11-17	—
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

9 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA NCT02784613	Phase 4	Completed	Sue Goldstein	10	2015-07 → 2017-04-17
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women NCT00630539	Phase 2	Completed	Shionogi	126	2007-08 → 2008-02
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus NCT01585558	Phase 3	Completed	Shionogi	180	2006-05-16 → 2008-09-18
A Clinical Study to Evaluate the Safety of Ospemifene NCT00566982	Phase 3	Completed	Shionogi	426	2007-10 → 2009-07
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause NCT02638337	Phase 3	Completed	Shionogi	631	2016-01-26 → 2017-07-05
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity NCT00729469	Phase 3	Completed	Shionogi	919	2008-07 → 2009-08
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women NCT00276094	Phase 3	Completed	Shionogi	826	2006-01 → 2007-12
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus NCT01586364	Phase 3	Completed	Shionogi	301	2006-05-08 → 2008-12-22
Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction NCT03018106	Phase 4	Terminated	Emory University	1	2017-06-30 → 2017-09-29

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$8.18

per ea

Lowest NADAC/Unit

$8.18

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
55494058030OSPHENA 60 MG TABLET	$8.18	EA	Brand	—	2026-06-17
55494058090OSPHENA 60 MG TABLET	$8.18	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$181.60

Highest Price

$577.33

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55494-0580-30OSPHENA 60MG TAB	$181.60	FSS	Duchesnay USA, Inc.	06/30/2027
55494-0580-90OSPHENA 60MG TAB	$577.33	FSS	Duchesnay USA, Inc.	06/30/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Osphena (2024)

Total Spending

$7.8M

Total Claims

17,063

Beneficiaries

4,417

Avg Cost/Unit

$7.89

Spending Trend

$4.6M(2019)→$6.5M(2020)→$7.8M(2021)→$8.1M(2022)→$8.5M(2023)→$7.8M(2024)

YoY Change:-6.5%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 3 use codes

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