Is there a generic for Eltrombopag olamine?

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Eltrombopag olamine, referencing the brand PROMACTA KIT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Eltrombopag olamine?

PROMACTA KIT (NDA 207027, NOVARTIS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Eltrombopag olamine?

The Orange Book lists 12 patents against Eltrombopag olamine products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Eltrombopag olamine are approved?

Eltrombopag olamine is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Eltrombopag olamine

Eltrombopag olamine: 2 brands, 10 generics; first approved Nov 20, 2008; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 10 ANDA applications approved.

Earliest patent expiry Jul 13, 2025

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 13, 2025

1 yr 1 mo ago

Brand (NDA) products

Originator applications

PROMACTA KITRLD
NOVARTISNDA 20702720182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 25MG ACID/PACKET FOR SUSPENSION ORAL Rx AB
EQ 12.5MG ACID/PACKET FOR SUSPENSION ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG ACID/PACKET	FOR SUSPENSION	ORAL	Rx	AB
EQ 12.5MG ACID/PACKET	FOR SUSPENSION	ORAL	Rx	AB

PROMACTARLD

NOVARTISNDA 02229120115 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 100MG ACID	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (10)

Abbreviated applications

ELTROMBOPAG OLAMINE
ACTAVIS LABS FLANDA 2088152026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
BIOCON PHARMAANDA 22066020264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
HIKMAANDA 22003320264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
DR REDDYSANDA 21912120264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
AMNEALANDA 21288420264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
MSNANDA 22025020264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
SOMERSET THERAPS LLCANDA 21963820264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
ZYDUS PHARMSANDA 21628120264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
HETERO LABS LTD VANDA 20678820254 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID TABLET ORAL Rx AB
EQ 25MG ACID TABLET ORAL Rx AB
EQ 50MG ACID TABLET ORAL Rx AB
EQ 75MG ACID TABLET ORAL Rx AB
ELTROMBOPAG OLAMINE
ANNORA PHARMAANDA 21662020242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 12.5MG ACID/PACKET FOR SUSPENSION ORAL Rx AB
EQ 25MG ACID/PACKET FOR SUSPENSION ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID	TABLET	ORAL	Rx	AB
EQ 25MG ACID	TABLET	ORAL	Rx	AB
EQ 50MG ACID	TABLET	ORAL	Rx	AB
EQ 75MG ACID	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 12.5MG ACID/PACKET	FOR SUSPENSION	ORAL	Rx	AB
EQ 25MG ACID/PACKET	FOR SUSPENSION	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7547719	Jul 13, 2025	1 yr 1 mo ago	SubstanceProductU-2452
7547719*PED	Jan 13, 2026	7 mo ago
8052994	Aug 01, 2027	in 1 yr	ProductU-1714
8071129	Aug 01, 2027	in 1 yr	ProductU-2451
8828430	Aug 01, 2027	in 1 yr	ProductU-1306
8062665	Aug 01, 2027	in 1 yr	ProductU-1714
8052993	Aug 01, 2027	in 1 yr	ProductU-1714
8828430*PED	Feb 01, 2028	in 1 yr 6 mo
8071129*PED	Feb 01, 2028	in 1 yr 6 mo
8062665*PED	Feb 01, 2028	in 1 yr 6 mo
8052993*PED	Feb 01, 2028	in 1 yr 6 mo
8052994*PED	Feb 01, 2028	in 1 yr 6 mo

Approval history

FDA approval span

First approval

Nov 20, 2008

18 yr ago

Most recent approval

Jun 17, 2026

2 mo ago

Approvals span 2008–2026 across 12 FDA applications.

Brand (NDA) 217%

Generic (ANDA) 1083%

Eltrombopag olamine: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo