Is there a generic for Ibrutinib?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Ibrutinib, referencing the brand IMBRUVICA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ibrutinib?

IMBRUVICA (NDA 217003, PHARMACYCLICS LLC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ibrutinib?

The Orange Book lists 84 patents against Ibrutinib products, with the earliest listed expiry in 2026. 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 Ibrutinib have FDA marketing exclusivity?

Yes. The Orange Book records 28 marketing-exclusivity periods for Ibrutinib. 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 Ibrutinib are approved?

Ibrutinib is approved in the following dosage forms: capsule, suspension, tablet.

FDA Orange Book · active-ingredient family

Ibrutinib

Ibrutinib: 3 brands, 2 generics; first approved Nov 13, 2013; generic available.

Generic available28 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Dec 28, 2026Latest exclusivity ends Feb 24, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 28, 2026

in 3 mo

Brand (NDA) products

Originator applications

IMBRUVICARLDRS
PHARMACYCLICS LLCNDA 2170032022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
70MG/ML SUSPENSION ORAL Rx —
IMBRUVICARLD
PHARMACYCLICS LLCNDA 21056320184 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
140MG TABLET ORAL Rx —
280MG TABLET ORAL Rx —
420MG TABLET ORAL Rx —
560MG TABLET ORAL Discontinued —
IMBRUVICARLD
PHARMACYCLICS LLCNDA 20555220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
140MG CAPSULE ORAL Rx AB
70MG CAPSULE ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
70MG/ML	SUSPENSION	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
140MG	TABLET	ORAL	Rx	—
280MG	TABLET	ORAL	Rx	—
420MG	TABLET	ORAL	Rx	—
560MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
140MG	CAPSULE	ORAL	Rx	AB
70MG	CAPSULE	ORAL	Rx	—

Generic (ANDA) products (2)

Abbreviated applications

IBRUTINIB
HETERO LABS LTD VANDA 2111822026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
140MG CAPSULE ORAL Rx AB
IBRUTINIB
ZYDUS LIFESCIENCESANDA 21134420212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
70MG CAPSULE ORAL Discontinued —
140MG CAPSULE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
140MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
70MG	CAPSULE	ORAL	Discontinued	—
140MG	CAPSULE	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPPNew patient population exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago
NPPNew patient population exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago
NPNew product exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago
NPPNew patient population exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago
NPPNew patient population exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago
NPPNew patient population exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago
NPPNew patient population exclusivity (3 years)
Aug 24, 2025
1 yr 2 mo ago
ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 2 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
8 mo ago

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
8952015	Dec 28, 2026	in 3 mo	U-1650
8497277	Dec 28, 2026	in 3 mo	U-1946
8703780	Dec 28, 2026	in 3 mo	U-1491
8476284	Dec 28, 2026	in 3 mo	U-1946
8735403	Dec 28, 2026	in 3 mo	SubstanceProduct
7514444	Dec 28, 2026	in 3 mo	SubstanceProduct
8957079	Dec 28, 2026	in 3 mo	SubstanceProduct
9181257	Dec 28, 2026	in 3 mo	Substance
8754091	Dec 28, 2026	in 3 mo	Product
8697711	Dec 28, 2026	in 3 mo	SubstanceProduct
8563563	Apr 26, 2027	in 7 mo	U-2219
7514444*PED	Jun 28, 2027	in 9 mo
8476284*PED	Jun 28, 2027	in 9 mo
8497277*PED	Jun 28, 2027	in 9 mo
8703780*PED	Jun 28, 2027	in 9 mo
8735403*PED	Jun 28, 2027	in 9 mo
8697711*PED	Jun 28, 2027	in 9 mo
8754091*PED	Jun 28, 2027	in 9 mo
8952015*PED	Jun 28, 2027	in 9 mo
8957079*PED	Jun 28, 2027	in 9 mo
9181257*PED	Jun 28, 2027	in 9 mo
8563563*PED	Oct 26, 2027	in 1 yr 1 mo
8008309	Nov 13, 2027	in 1 yr 1 mo	SubstanceProduct
8008309*PED	May 13, 2028	in 1 yr 7 mo
10004746	Jun 03, 2031	in 4 yr 9 mo	U-2242
9801881	Jun 03, 2031	in 4 yr 9 mo	U-1491
8999999	Jun 03, 2031	in 4 yr 9 mo	U-2228
9801883	Jun 03, 2031	in 4 yr 9 mo	U-2159
9125889	Jun 03, 2031	in 4 yr 9 mo	U-1650
10016435	Jun 03, 2031	in 4 yr 9 mo	U-1650
10478439	Jun 03, 2031	in 4 yr 9 mo	U-1684
11672803	Jun 03, 2031	in 4 yr 9 mo	U-2242
10751342	Jun 03, 2031	in 4 yr 9 mo	U-1946
8754090	Jun 03, 2031	in 4 yr 9 mo	U-1456
9814721	Jun 03, 2031	in 4 yr 9 mo	U-1947
10653696	Jun 03, 2031	in 4 yr 9 mo	U-1456
10004746*PED	Dec 03, 2031	in 5 yr 3 mo
8999999*PED	Dec 03, 2031	in 5 yr 3 mo
9125889*PED	Dec 03, 2031	in 5 yr 3 mo
9801881*PED	Dec 03, 2031	in 5 yr 3 mo
9801883*PED	Dec 03, 2031	in 5 yr 3 mo
10016435*PED	Dec 03, 2031	in 5 yr 3 mo
10751342*PED	Dec 03, 2031	in 5 yr 3 mo
10478439*PED	Dec 03, 2031	in 5 yr 3 mo
8754090*PED	Dec 03, 2031	in 5 yr 3 mo
9814721*PED	Dec 03, 2031	in 5 yr 3 mo
10653696*PED	Dec 03, 2031	in 5 yr 3 mo
10961251	Jun 03, 2033	in 6 yr 9 mo	Product
9713617	Jun 03, 2033	in 6 yr 9 mo	Product
10294231	Jun 03, 2033	in 6 yr 9 mo	Product
9725455	Jun 03, 2033	in 6 yr 9 mo	Substance
10294232	Jun 03, 2033	in 6 yr 9 mo	Product
10125140	Jun 03, 2033	in 6 yr 9 mo	SubstanceProduct
10106548	Jun 03, 2033	in 6 yr 9 mo	SubstanceProduct
10752634	Jun 03, 2033	in 6 yr 9 mo	Product
9540382	Aug 18, 2033	in 6 yr 11 mo	U-1491
9296753	Oct 30, 2033	in 7 yr 2 mo	Substance
9713617*PED	Dec 03, 2033	in 7 yr 3 mo
9725455*PED	Dec 03, 2033	in 7 yr 3 mo
10106548*PED	Dec 03, 2033	in 7 yr 3 mo
10125140*PED	Dec 03, 2033	in 7 yr 3 mo
10294231*PED	Dec 03, 2033	in 7 yr 3 mo
10294232*PED	Dec 03, 2033	in 7 yr 3 mo
10961251*PED	Dec 03, 2033	in 7 yr 3 mo
10752634*PED	Dec 03, 2033	in 7 yr 3 mo
9540382*PED	Feb 18, 2034	in 7 yr 6 mo
9296753*PED	Apr 30, 2034	in 7 yr 8 mo
10463668	Oct 24, 2034	in 8 yr 2 mo	U-2654
10695350	Oct 24, 2034	in 8 yr 2 mo	U-2846
9795604	Oct 24, 2034	in 8 yr 2 mo	U-3422
9795604*PED	Apr 24, 2035	in 8 yr 8 mo
10463668*PED	Apr 24, 2035	in 8 yr 8 mo
10695350*PED	Apr 24, 2035	in 8 yr 8 mo
10213386	Mar 03, 2036	in 9 yr 6 mo	Product
9655857	Mar 03, 2036	in 9 yr 6 mo	Product
12551448	Mar 03, 2036	in 9 yr 6 mo	Product
10010507	Mar 03, 2036	in 9 yr 6 mo	Product
10828259	Mar 03, 2036	in 9 yr 6 mo	Product
12364698	Apr 06, 2036	in 9 yr 7 mo	Product
9655857*PED	Sep 03, 2036	in 10 yr
10010507*PED	Sep 03, 2036	in 10 yr
10213386*PED	Sep 03, 2036	in 10 yr
10828259*PED	Sep 03, 2036	in 10 yr
12201690	Jun 14, 2039	in 12 yr 10 mo	Product

Approval history

FDA approval span

First approval

Nov 13, 2013

13 yr 1 mo ago

Most recent approval

Sep 08, 2026

1 mo ago

Approvals span 2013–2026 across 5 FDA applications.

Brand (NDA) 360%

Generic (ANDA) 240%

Ibrutinib: 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.

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