Viewing data from:

PROMACTA

NDA

ELTROMBOPAG OLAMINE | N022291 | NOVARTIS PHARMACEUTICALS CORP

5 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Expired (1)Active (5)TodayPED (+6 mo)

2026

2027

2028

Today

Jan. 13, 2026

Feb. 1, 2028

Feb. 1, 2028

Feb. 1, 2028

Feb. 1, 2028

Feb. 1, 2028

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Promacta (2023)

Total Spending

$557.7M

Total Claims

39,505

Beneficiaries

5,708

Avg Cost/Unit

$397.68

Spending Trend

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

YoY Change:+11.3%

5yr CAGR:+9.6%

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

API Supply Chain22 active DMFs1 inactive

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

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

BIOCON LTDELTROMBOPAG OLAMINE

DMF 431832025

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

6 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 20, 2008

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7547719	Jul 13, 2025PED: Jan 13, 2026	PED	Yes	Yes	—
8052993	Aug 1, 2027PED: Feb 1, 2028	PED	—	Yes	—
8052994	Aug 1, 2027PED: Feb 1, 2028	PED	—	Yes	—
8062665	Aug 1, 2027PED: Feb 1, 2028	PED	—	Yes	—
8071129	Aug 1, 2027PED: Feb 1, 2028	PED	—	Yes	—
8828430	Aug 1, 2027PED: Feb 1, 2028	PED	—	Yes	—

#002 — EQ 50MG ACID

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 2008

#003 — EQ 75MG ACID

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 8, 2009

#004 — EQ 12.5MG ACID

RLDAB

6 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

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2012