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ELLA

NDA

ULIPRISTAL ACETATE | N022474 | LABORATOIRE HRA PHARMA

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

Today

Jun. 12, 2030

Jun. 2, 2030

Feb. 20, 2029

Jun. 12, 2030

Apr. 13, 2030

Dec. 8, 2028

Apr. 13, 2030

Apr. 13, 2030

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
Laboratoire HRA Pharma v. Teva Pharmaceuticals USA Inc. 1:2015cv00045 3 patentsANDA 207952ulipristal acetate	D. Del.	2015-01-16	Terminated 2016-08-08	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

44 trials from ClinicalTrials.gov, 24 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ovarian Function With ENG Implant and UPA Use NCT04291001	Early Phase 1	Completed	University of Utah	40	2020-09-04 → 2024-01-12
EC PK in Women With Normal and Obese BMI NCT02689804	Phase 4	Completed	Columbia University	34	2015-07-10 → 2017-02-03
Ulipristal for Endometriosis-related Pelvic Pain NCT02213081	Phase 4	Completed	Northwestern University	1	2015-02 → 2016-12
PGL4001 Versus Placebo in Uterine Myomas NCT00755755	Phase 3	Completed	PregLem SA	241	2008-10 → 2010-08
Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation NCT02922127	Phase 1	Completed	Columbia University	29	2016-12-16 → 2019-10-21
Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days NCT01953679	Phase 2	Completed	Premier Research	180	2014-03 → 2015-11
PGL4001 Versus GnRH-agonist in Uterine Myomas NCT00740831	Phase 3	Completed	PregLem SA	301	2008-08 → 2010-06
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata NCT01642472	Phase 3	Completed	PregLem SA	64	2012-07 → 2015-04
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata NCT01156857	Phase 3	Completed	PregLem SA	209	2010-07 → 2012-02
Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids NCT02465814	Phase 2	Completed	Bayer	120	2015-06 → 2016-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$37.09

per ea

Lowest NADAC/Unit

$37.09

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
73302045601ELLA 30 MG TABLET	$37.09	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 (1 FSS, 1 Big4)

Lowest Price

$18.16

Highest Price

$21.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73302-0456-01ELLA 30MG TAB	$21.19	FSS	HRA Pharma America, Inc.	04/30/2026
73302-0456-01ELLA 30MG TAB	$18.16	Big4	HRA Pharma America, Inc.	04/30/2026

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

API Supply Chain5 active DMFs1 inactive

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

CURIA SPAIN SAUULIPRISTAL ACETATE MICRONIZED

DMF 215272008

FORMOSA LABORATORIES INCULIPRISTAL ACETATE

DMF 257012012

TAPI NL BVULIPRISTAL ACETATE

DMF 279452014

NEWCHEM SPAULIPRISTAL ACETATE

DMF 322342017

INDUSTRIALE CHIMICA SRLULIPRISTAL ACETATE

DMF 329542018

GEDEON RICHTER PLCInactiveULIPRISTAL ACETATE MICRONIZED

DMF 268612013

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 25, 2021	SUPPL -11	View Letter (PDF)
May 3, 2018	SUPPL -10	View Letter (PDF)
Mar 11, 2015	SUPPL -7	View Letter (PDF)
Sep 3, 2014	SUPPL -5	View Letter (PDF)
Jun 17, 2014	SUPPL -4	View Letter (PDF)
May 4, 2012	SUPPL -2	View Letter (PDF)
Aug 13, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG

RLDAB

8 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 13, 2010

Patents (8) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8426392	Jun 12, 2030	—	—	—		—
8512745	Jun 2, 2030	—	—	Yes	—	—
8735380	Feb 20, 2029	—	—	Yes	—	—
8962603	Jun 12, 2030	—	—	—		—
9283233	Apr 13, 2030	—	—	—		—
9844510	Dec 8, 2028	—	—	Yes	—	—
10159681	Apr 13, 2030	—	—	—		—
10772897	Apr 13, 2030	—	—	—		—