Is there a generic for Nintedanib esylate?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Nintedanib esylate, referencing the brand OFEV. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nintedanib esylate?

OFEV (NDA 205832, BOEHRINGER INGELHEIM) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Nintedanib esylate?

The Orange Book lists 8 patents against Nintedanib esylate 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.

Does Nintedanib esylate have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Nintedanib esylate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Nintedanib esylate are approved?

Nintedanib esylate is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Nintedanib esylate

Nintedanib esylate: 1 brand, 6 generics; first approved Oct 15, 2014; generic available.

Generic available4 exclusivity periods

Generic status & protection

Generic available: 6 ANDA applications approved.

Earliest patent expiry Oct 01, 2025Latest exclusivity ends Mar 06, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 01, 2025

10 mo ago

Brand (NDA) products

Originator applications

OFEVRLD
BOEHRINGER INGELHEIMNDA 20583220142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Generic (ANDA) products (6)

Abbreviated applications

NINTEDANIB ESYLATE
HUMANWELL PURACAPANDA 21847220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
NINTEDANIB ESYLATE
APOTEXANDA 21922720262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
NINTEDANIB ESYLATE
CIPLAANDA 21260920262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
NINTEDANIB ESYLATE
DEXCELANDA 21981920262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
NINTEDANIB ESYLATE
DR REDDYSANDA 21928320262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB
NINTEDANIB ESYLATE
SANDOZANDA 21691520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE CAPSULE ORAL Rx AB
EQ 150MG BASE CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	CAPSULE	ORAL	Rx	AB
EQ 150MG BASE	CAPSULE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-261Orphan-drug exclusivity (7 years)
Sep 06, 2026
in 1 mo
PEDPediatric exclusivity (adds 6 months)
Mar 06, 2027
in 7 mo
ODE-261Orphan-drug exclusivity (7 years)
Sep 06, 2026
in 1 mo
PEDPediatric exclusivity (adds 6 months)
Mar 06, 2027
in 7 mo

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
6762180	Oct 01, 2025	10 mo ago	SubstanceProduct
10154990	Jan 08, 2026	7 mo ago	U-2620
6762180*PED	Apr 01, 2026	4 mo ago
10154990*PED	Jul 08, 2026	27 d ago
10105323	Jun 04, 2029	in 2 yr 11 mo	Product
9907756	Jun 07, 2029	in 2 yr 11 mo	Product
10105323*PED	Dec 04, 2029	in 3 yr 5 mo
9907756*PED	Dec 07, 2029	in 3 yr 5 mo

Approval history

FDA approval span

First approval

Oct 15, 2014

12 yr ago

Most recent approval

Jul 09, 2026

26 d ago

Approvals span 2014–2026 across 7 FDA applications.

Brand (NDA) 114%

Generic (ANDA) 686%

Nintedanib esylate: 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