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ORILISSA

NDA

ELAGOLIX SODIUM | N210450 | ABBVIE INC

2 strengths9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Active (9)Today

2026

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2041

Today

Jul. 6, 2029

Sep. 1, 2036

Sep. 1, 2036

Mar. 14, 2034

Jul. 23, 2039

Aug. 27, 2040

Apr. 19, 2038

Mar. 14, 2034

Aug. 20, 2038

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

6 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Hetero Labs Limited et al 1:2025cv00625 9 patentsANDA 217690elagolix sodium	D. Del.	2025-05-19	Terminated 2025-12-22	—
Hetero Labs Limited et al v. AbbVie Inc. et al 1:2025cv00431 1 patentANDA 217690elagolix	D. Del.	2025-04-07	Terminated 2025-04-22	—
AbbVie Inc. v. Sandoz Inc. 1:2023cv01212 10 patentsANDA 217551elagolix sodium	D. Del.	2023-10-25	Terminated 2024-01-29	—
AbbVie Inc. v. Sun Pharmaceutical Industries Limited 1:2023cv00684 6 patentsANDA 215804elagolix sodium	D. Del.	2023-06-23	Terminated 2024-06-21	—
AbbVie Inc. v. Prinston Pharmaceutical Inc. et al 1:2023cv00607 7 patents	D. Del.	2023-06-02	Terminated 2024-06-20	—
AbbVie Inc. v. Prinston Pharmaceutical Inc. et al 1:2023cv00470 5 patentsANDA 217296elagolix sodium	D. Del.	2023-04-28	Terminated 2024-06-20	—

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 Orilissa (2023)

Total Spending

$3.6M

Total Claims

2,624

Beneficiaries

575

Avg Cost/Unit

$37.01

Spending Trend

$1.8M(2019)→$3.0M(2020)→$3.3M(2021)→$3.7M(2022)→$3.6M(2023)

YoY Change:+4.5%

5yr CAGR:+8.4%

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

API Supply Chain20 active DMFs

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

FORMOSA LABORATORIES INCELAGOLIX SODIUM

DMF 349072020

DR REDDYS LABORATORIES LTDELAGOLIX SODIUM

DMF 354732021

MSN LIFE SCIENCES PRIVATE LTDELAGOLIX SODIUM

DMF 357012021

SCINOPHARM TAIWAN LTDELAGOLIX SODIUM

DMF 357082021

SUN PHARMACEUTICAL INDUSTRIES LTDELAGOLIX SODIUM

DMF 363442022

TAPI NL BVELAGOLIX SODIUM

DMF 365702022

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDELAGOLIX SODIUM

DMF 366272021

ALIVUS LIFE SCIENCES LTDELAGOLIX SODIUM

DMF 366332022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELAGOLIX SODIUM

DMF 366462021

LUPIN MANUFACTURING SOLUTIONS LTDELAGOLIX SODIUM

DMF 366692022

CHANGZHOU PHARMACEUTICAL FACTORYELAGOLIX SODIUM

DMF 367382022

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDELAGOLIX SODIUM

DMF 368232022

NEULAND LABORATORIES LTDELAGOLIX SODIUM

DMF 369472022

HETERO LABS LTDELAGOLIX SODIUM

DMF 370372022

CHENGDA PHARMACEUTICALS CO LTDELAGOLIX SODIUM

DMF 374892022

YANGZHOU AURISCO PHARMACEUTICAL CO LTDELAGOLIX SODIUM

DMF 375152022

SHANDONG NEW TIME PHARMACEUTICAL CO LTDELAGOLIX SODIUM

DMF 376962022

MOEHS IBERICA SLELAGOLIX SODIUM

DMF 382202023

OPTIMUS DRUGS PRIVATE LTDELAGOLIX SODIUM

DMF 397782024

USV PRIVATE LTDELAGOLIX SODIUM

DMF 403262024

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2025	SUPPL -11	View Letter (PDF)
Jun 6, 2023	SUPPL -9	View Letter (PDF)
Feb 3, 2021	SUPPL -6	View Letter (PDF)
Feb 3, 2021	SUPPL -5	View Letter (PDF)
Feb 3, 2021	SUPPL -4	View Letter (PDF)
Aug 30, 2019	SUPPL -2	View Letter (PDF)
Jul 24, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 150MG BASE

RLD

8 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 23, 2018

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7419983	Jul 6, 2029	—	Yes	Yes		—
10537572	Sep 1, 2036	—	—	—		—
10682351	Sep 1, 2036	—	—	—		—
11542239	Jul 23, 2039	—	Yes	Yes	—	—
11690845	Aug 27, 2040	—	—	—		—
11690854	Apr 19, 2038	—	—	—		—
11707464	Mar 14, 2034	—	—	—		—
12102637	Aug 20, 2038	—	—	Yes	—	—

#002 — EQ 200MG BASE

RLD

5 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 23, 2018