Viewing data from:

PROMACTA

NDA

ELTROMBOPAG OLAMINE | N022291 | NOVARTIS PHARMACEUTICALS CORP

5 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)

2026

Today

7547719

Jan. 13, 2026

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVARTIS PHARMACEUTICALS CORPORATION et al v. TARO PHARMACEUTICALS USA, INC. et al 2:2025cv13193 5 patentsANDA 220280eltrombopag olamine	D.N.J.	2025-07-11	Terminated 2025-11-14	—
Novartis Pharmaceuticals Corporation et al v. Zenara Pharma Private Limited et al 1:2025cv00644 1 patentANDA 220033eltrombopag olamine	D. Del.	2025-05-23	Terminated 2025-07-01	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy NCT02071901	Phase 2	Completed	Case Comprehensive Cancer Center	31	2014-08-14 → 2019-01-06
Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy NCT01428635	Phase 2/3	Completed	M.D. Anderson Cancer Center	21	2012-01-13 → 2022-01-03
Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant NCT01927731	Phase 2	Completed	M.D. Anderson Cancer Center	48	2013-10-14 → 2023-06-06
Eltrombopag for the Treatment of Immune ThrombocytoPenia (ITP) Secondary to Chronic Lymphoproliferative Disorders (LPDs)NCT01610180	Phase 2	Completed	Fondazione Progetto Ematologia	18	2012-06 → 2018-06-30
Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag NCT01147809	Phase 2	Completed	GlaxoSmithKline	130	2010-06 → 2015-03
A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)NCT01098487	Phase 4	Completed	GlaxoSmithKline	167	2010-05 → 2014-05
Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)NCT00903422	Phase 1	Completed	GlaxoSmithKline	98	2009-05-14 → 2013-12-05
EXTEND (Eltrombopag Extended Dosing Study)NCT00351468	Phase 3	Completed	Novartis Pharmaceuticals	302	2006-06 → 2015-07
Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia NCT01550185	Phase 1	Terminated	Roswell Park Cancer Institute	10	2012-05 → 2014-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$4465.94

Highest Price

$17675.84

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0684-15PROMACTA 12.5MG TAB	$5298.37	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0684-15PROMACTA 12.5MG TAB	$6511.58	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0685-15PROMACTA 25MG TAB	$5336.35	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0685-15PROMACTA 25MG TAB	$6511.58	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0686-15PROMACTA 50MG TAB	$9643.60	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0686-15PROMACTA 50MG TAB	$11783.90	FSS	Novartis Pharmaceuticals Corporation	08/31/2026

Showing 6 of 10 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Promacta (2024)

Total Spending

$672.4M

Total Claims

45,852

Beneficiaries

6,666

Avg Cost/Unit

$408.06

Spending Trend

$304.4M(2019)→$341.8M(2020)→$389.5M(2021)→$454.8M(2022)→$557.7M(2023)→$672.4M(2024)

YoY Change:+2.6%

5yr CAGR:+7.7%

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

API Supply Chain22 active DMFs1 inactive

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

BIOCON LTDELTROMBOPAG OLAMINE

DMF 431832025

HETERO DRUGS LTDELTROMBOPAG OLAMINE

DMF 267462012

MSN LABORATORIES PRIVATE LTDELTROMBOPAG OLAMINE [ROUTE CODE - "EA"]

DMF 288422014

RAKS PHARMA PVT LTDELTROMBOPAG OLAMINE

DMF 316672017

ZYDUS LIFESCIENCES LTDELTROMBOPAG OLAMINE

DMF 349912020

APITORIA PHARMA PRIVATE LTDELTROMBOPAG OLAMINE

DMF 363332021

TAPI NL BVELTROMBOPAG OLAMINE

DMF 367692022

CHANGZHOU PHARMACEUTICAL FACTORYELTROMBOPAG OLAMINE

DMF 371342022

CHEMWERTH INCELTROMBOPAG OLAMINE

DMF 372692022

EXTROVIS AGELTROMBOPAG OLAMINE

DMF 379072023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELTROMBOPAG OLAMINE

DMF 380082023

QUIMICA SINTETICA SAELTROMBOPAG OLAMINE

DMF 382542023

GUANGDONG RAFFLES PHARMATECH CO LTDELTROMBOPAG OLAMINE

DMF 389142023

OPTIMUS DRUGS PRIVATE LTDELTROMBOPAG OLAMINE

DMF 391062023

GRANULES INDIA LTDELTROMBOPAG OLAMINE

DMF 391292023

SHILPA PHARMA LIFESCIENCES LTDELTROMBOPAG OLAMINE

DMF 397542024

CAMBREX PROFARMACO MILANO SRLELTROMBOPAG OLAMINE

DMF 402212024

ZHEJIANG HENGKANG PHARMACEUTICAL CO LTDELTROMBOPAG OLAMINE

DMF 403572024

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDELTROMBOPAG OLAMINE

DMF 408682024

TOPHARMAN TANCHENG CO LTDELTROMBOPAG OLAMINE

DMF 409862025

SYNTHIMED LABS PRIVATE LTDELTROMBOPAG OLAMINE

DMF 413662025

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDELTROMBOPAG OLAMINE

DMF 419102025

GRANULES INDIA LTDInactiveELTROMBOPAG OLAMINE

DMF 340692019

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

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2025	SUPPL -40	View Letter (PDF)
Jun 9, 2025	SUPPL -41	View Letter (PDF)
Sep 19, 2023	SUPPL -38	View Letter (PDF)
Mar 10, 2023	SUPPL -37	View Letter (PDF)
Jan 17, 2023	SUPPL -35	View Letter (PDF)
Jan 17, 2023	SUPPL -35	View Letter (PDF)
Apr 4, 2022	SUPPL -33	View Letter (PDF)
Apr 28, 2021	SUPPL -31	View Letter (PDF)
Apr 30, 2020	SUPPL -27	View Letter (PDF)
Apr 29, 2020	SUPPL -26	View Letter (PDF)
Dec 7, 2018	SUPPL -21	View Letter (PDF)
Jul 26, 2018	SUPPL -20	View Letter (PDF)
Oct 6, 2017	SUPPL -19	View Letter (PDF)
Mar 14, 2017	SUPPL -17	View Letter (PDF)
Jun 12, 2015	SUPPL -15	View Letter (PDF)
Apr 8, 2015	SUPPL -14	View Letter (PDF)
Aug 28, 2014	SUPPL -12	View Letter (PDF)
Jul 17, 2014	SUPPL -13	View Letter (PDF)
Apr 28, 2014	SUPPL -11	View Letter (PDF)
Feb 12, 2014	SUPPL -10	View Letter (PDF)
Nov 19, 2012	SUPPL -8	View Letter (PDF)
Dec 7, 2011	SUPPL -6	View Letter (PDF)
Mar 2, 2011	SUPPL -1	View Letter (PDF)
Mar 9, 2010	SUPPL -3	View Letter (PDF)
Nov 26, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 25MG ACID

RLDAB

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 20, 2008

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7547719	Jul 13, 2025PED: Jan 13, 2026	PED	Yes	Yes	—
7547719	Jul 13, 2025PED: Jan 13, 2026	PED	Yes	Yes	—
7547719	Jul 13, 2025PED: Jan 13, 2026	PED	Yes	Yes	—
7547719	Jul 13, 2025PED: Jan 13, 2026	PED	Yes	Yes	—

#002 — EQ 50MG ACID

RLDAB

5 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 2008

#003 — EQ 75MG ACID

RLDAB

5 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 8, 2009

#004 — EQ 12.5MG ACID

RLDAB

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 20, 2011

#005 — EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

3 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2012