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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ella (2023)

Total Spending

$741.27

Total Claims

Beneficiaries

Avg Cost/Unit

$39.01

Spending Trend

$24K(2019)→$17K(2020)→$6K(2021)→$4K(2022)→$741.27(2023)

YoY Change:+1.5%

5yr CAGR:+1.1%

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

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)

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	—	—	—		—