Case	Court	Filed	Status	Judge
THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. et al 3:2020cv14933 19 patentsANDA 214293estradiol and progesterone	D.N.J.	2020-10-23	Terminated 2020-11-17	—
THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. et al 3:2020cv05256 12 patentsANDA 214293estradiol and progesterone	D.N.J.	2020-04-29	Terminated 2021-02-25	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

25 trials from ClinicalTrials.gov, 1 active, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Role of Estrogen in the Neurobiology of Eating Disorders NCT03740204	Phase 2	Active	Massachusetts General Hospital	120	2019-06-13 → 2026-12-31
Midlife Cholesterol Study NCT00361075	Phase 4	Completed	Northwestern University	120	1998-07 → 2005-05
Evaluation of Physiologic and Standard Sex Steroid Replacement Regimens in Women With Premature Ovarian Failure NCT00732693	Phase 4	Completed	University of Edinburgh	42	2002-02 → 2006-11
Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women NCT01432028	N/A	Completed	Denusa Wiltgen	90	2007-03 → 2011-04
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients NCT01980680	Phase 4	Completed	Peter Humaidan	50	2014-12 → 2020-05
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study NCT01504139	Phase 4	Completed	Regionshospitalet Viborg, Skive	93	2012-01 → 2014-08
Effects of Raloxifene on Hormone Levels NCT00026962	Phase 2	Completed	National Cancer Institute (NCI)	60	1999-09 → 2003-08
Endometrial Receptivity After GnRH Agonist Triggering NCT01500863	Phase 4	Completed	IVI Madrid	35	2011-11
Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy NCT02467673	Phase 2	Completed	University Potiguar	185	2012-01 → 2012-07
Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation NCT01943812	Phase 4	Completed	Peter Humaidan	287	2013-12 → 2020-04

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

$8.85

per ea

Lowest NADAC/Unit

$8.53

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68308075130BIJUVA 0.5 MG-100 MG CAPSULE	$8.85	EA	Brand	—	2026-06-01
68308075030BIJUVA 1 MG-100 MG CAPSULE	$8.53	EA	Brand	—	2026-06-01

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

$155.79

Highest Price

$192.38

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68308-0750-30BIJUVA	$155.79	FSS	Mayne Pharma Commercial LLC	07/14/2030
68308-0751-30BIJUVA	$192.38	FSS	Mayne Pharma Commercial LLC	07/14/2030

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

Medicare Part D Spending

CMS annual spending data for Bijuva (2024)

Total Spending

$728K

Total Claims

1,694

Beneficiaries

507

Avg Cost/Unit

$8.11

Spending Trend

$54K(2019)→$214K(2020)→$357K(2021)→$443K(2022)→$621K(2023)→$728K(2024)

YoY Change:-4.1%

5yr CAGR:+3.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 12, 2026	SUPPL -13	View Letter (PDF)
Feb 16, 2024	SUPPL -11	View Letter (PDF)
Dec 29, 2021	SUPPL -6	View Letter (PDF)
Jun 24, 2021	SUPPL -1	View Letter (PDF)
Jun 24, 2021	SUPPL -3	View Letter (PDF)
Oct 30, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG;100MG

RLD

22 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 28, 2018

Patents (22) · 12 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8633178	Nov 21, 2032	—	—	Yes	—	—
8846648	Nov 21, 2032	—	—	—		—
8846649	Nov 21, 2032	—	—	Yes		—
8987237	Nov 21, 2032	—	—	Yes	—	—
8993548	Nov 21, 2032	—	—	Yes	—	—
8993549	Nov 21, 2032	—	—	Yes	—	—
9006222	Nov 21, 2032	—	—	Yes		—
9114145	Nov 21, 2032	—	—	—		—
9114146	Nov 21, 2032	—	—	Yes		—
9301920	Nov 21, 2032	—	—	Yes		—
10052386	Nov 21, 2032	—	—	Yes	—	—
10206932	Nov 21, 2032	—	—	—		—
10639375	Nov 21, 2032	—	—	Yes	—	—
10675288	Nov 21, 2032	—	—	—		—
10806740	Nov 21, 2032	—	—	Yes		—
11033626	Nov 21, 2032	—	—	Yes		—
11103513	Nov 21, 2032	—	—	—		—
11103516	Nov 21, 2032	—	—	Yes	—	—
11110099	Nov 21, 2032	—	—	Yes	—	—
11529360	Nov 21, 2032	—	—	Yes	—	—
11793819	Nov 21, 2032	—	—	—		—
11865179	Nov 21, 2032	—	Yes	Yes	—	—

#002 — 0.5MG;100MG

RLD

17 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 28, 2021