Viewing data from:

LETAIRIS

NDA

AMBRISENTAN | N022081 | GILEAD SCIENCES INC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

Today

8377933

Dec. 11, 2027

9474752

Dec. 11, 2027

9549926

Oct. 14, 2031

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
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd. et al 1:2021cv01735	D. Del.	2021-12-10	Terminated 2022-04-15	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

45 trials from ClinicalTrials.gov, 31 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial NCT01224210	Phase 3	Completed	Tufts Medical Center	30	2010-03 → 2020-03
Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration NCT01352065	Phase 2/3	Completed	Center for Health Sciences, Serbia	30	2011-01 → 2013-05
A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).NCT00725361	N/A	Completed	Stanford University	20	2008-06 → 2010-12
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension NCT00424021	Phase 2	Completed	Gilead Sciences	54	2003-04 → 2009-12
A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)NCT01178073	Phase 3	Completed	GlaxoSmithKline	610	2010-10-01 → 2014-07-31
Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)NCT01808313	Phase 3	Completed	GlaxoSmithKline	134	2012-12-01 → 2014-08-15
Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.NCT00423748	Phase 3	Completed	Gilead Sciences	186	2003-12 → 2006-02
An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH)NCT01338636	Phase 4	Completed	Brigham and Women's Hospital	30	2008-09 → 2016-05
The Role of Endothelin-1 in Sickle Cell Disease NCT02712346	Phase 1	Completed	Augusta University	26	2015-09 → 2019-11-30
Ambrisentan in Single Ventricle NCT02080637	Phase 2	Completed	Kevin Hill	16	2015-07 → 2017-08-20

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$2750.21

Highest Price

$7616.00

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-0801-01LETAIRIS 5MG TAB	$7108.28	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0801-01LETAIRIS 5MG TAB	$7108.28	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0802-01LETAIRIS 10MG TAB	$7616.00	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0802-01LETAIRIS 10MG TAB	$7616.00	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0802-05LETAIRIS 10MG TAB	$2750.21	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0802-05LETAIRIS 10MG TAB	$2750.21	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0801-05LETAIRIS 5MG TAB	$2750.21	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0801-05LETAIRIS 5MG TAB	$2750.21	Big4	Gilead Sciences, Inc.	09/29/2026

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

Medicare Part D Spending

CMS annual spending data for Letairis (2024)

Total Spending

$82.7M

Total Claims

6,082

Beneficiaries

1,309

Avg Cost/Unit

$408.89

Spending Trend

$417.4M(2019)→$165.4M(2020)→$125.8M(2021)→$101.0M(2022)→$88.6M(2023)→$82.7M(2024)

YoY Change:-5.5%

5yr CAGR:+4.3%

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

API Supply Chain9 active DMFs1 inactive

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

MATRIX PHARMACORP PRIVATE LTDAMBRISENTAN

DMF 245052010

MSN LABORATORIES PRIVATE LTDAMBRISENTAN [ROUTE CODE - AB]

DMF 261562012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 275052013

MEDICHEM MANUFACTURING (MALTA) LTDAMBRISENTAN (MED-200028/M)

DMF 287812014

CIPLA LTDAMBRISENTAN

DMF 294902015

MEGAFINE PHARMA P LTDAMBRISENTAN

DMF 297922015

JIANGSU JOYGLORY PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 307992016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 311332016

SUN PHARMACEUTICAL INDUSTRIES LTDAMBRISENTAN

DMF 361052021

WATSON PHARMA PRIVATE LTDInactiveAMBRISENTAN

DMF 251342011

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

Approval Letters

28 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -45	View Letter (PDF)
Aug 20, 2024	SUPPL -44	View Letter (PDF)
Jun 9, 2021	SUPPL -43	View Letter (PDF)
Dec 23, 2020	SUPPL -42	View Letter (PDF)
Aug 27, 2019	SUPPL -41	View Letter (PDF)
Mar 29, 2019	SUPPL -39	View Letter (PDF)
Dec 7, 2018	SUPPL -40	View Letter (PDF)
Sep 29, 2017	SUPPL -38	View Letter (PDF)
Jul 25, 2017	SUPPL -37	View Letter (PDF)
Dec 19, 2016	SUPPL -36	View Letter (PDF)
Oct 6, 2015	SUPPL -33	View Letter (PDF)
Oct 30, 2014	SUPPL -32	View Letter (PDF)
May 6, 2014	SUPPL -29	View Letter (PDF)
Feb 4, 2014	SUPPL -30	View Letter (PDF)
Aug 22, 2013	SUPPL -19	View Letter (PDF)
Oct 23, 2012	SUPPL -22	View Letter (PDF)
Feb 17, 2012	SUPPL -14	View Letter (PDF)
Jul 21, 2011	SUPPL -18	View Letter (PDF)
Mar 8, 2011	SUPPL -17	View Letter (PDF)
Oct 20, 2010	SUPPL -12	View Letter (PDF)
Aug 26, 2010	SUPPL -16	View Letter (PDF)
Nov 24, 2009	SUPPL -10	View Letter (PDF)
Jul 8, 2009	SUPPL -11	View Letter (PDF)
Jun 10, 2009	SUPPL -8	View Letter (PDF)
Oct 14, 2008	SUPPL -4	View Letter (PDF)
Feb 19, 2008	SUPPL -2	View Letter (PDF)
Dec 3, 2007	SUPPL -1	View Letter (PDF)
Jul 5, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLDAB

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 15, 2007

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8377933	Dec 11, 2027	—	—	—	—
9474752	Dec 11, 2027	—	—	—	—
9549926	Oct 14, 2031	—	—	—	—

#002 — 10MG

RLDAB

3 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 15, 2007