Is there a generic for Exenatide synthetic?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Exenatide synthetic, referencing the brand BYDUREON BCISE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Exenatide synthetic?

BYDUREON BCISE (NDA 209210, ASTRAZENECA AB) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Exenatide synthetic?

The Orange Book lists 14 patents against Exenatide synthetic 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 Exenatide synthetic are approved?

Exenatide synthetic is approved in the following dosage forms: for suspension, extended release, injectable, suspension, extended release.

FDA Orange Book · active-ingredient family

Exenatide synthetic

Exenatide synthetic: 3 brands, 1 generic; first approved Apr 28, 2005; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Oct 04, 2025

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 04, 2025

11 mo ago

Brand (NDA) products

Originator applications

BYDUREON BCISERLD
ASTRAZENECA ABNDA 2092102017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/0.85ML (2MG/0.85ML) SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Discontinued	—

BYDUREONRLD

ASTRAZENECA ABNDA 02220020122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Discontinued	—
2MG	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Discontinued	—

BYETTARLD
ASTRAZENECA ABNDA 02177320052 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MCG/1.2ML (250MCG/ML) INJECTABLE SUBCUTANEOUS Discontinued —
600MCG/2.4ML (250MCG/ML) INJECTABLE SUBCUTANEOUS Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MCG/1.2ML (250MCG/ML)	INJECTABLE	SUBCUTANEOUS	Discontinued	—
600MCG/2.4ML (250MCG/ML)	INJECTABLE	SUBCUTANEOUS	Discontinued	—

Generic (ANDA) products (1)

Abbreviated applications

EXENATIDE SYNTHETICRS
AMNEALANDA 20669720242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
300MCG/1.2ML (250MCG/ML) INJECTABLE SUBCUTANEOUS Rx —
600MCG/2.4ML (250MCG/ML) INJECTABLE SUBCUTANEOUS Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MCG/1.2ML (250MCG/ML)	INJECTABLE	SUBCUTANEOUS	Rx	—
600MCG/2.4ML (250MCG/ML)	INJECTABLE	SUBCUTANEOUS	Rx	—

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
6515117	Oct 04, 2025	11 mo ago	SubstanceProductU-2588
6515117*PED	Apr 04, 2026	5 mo ago
8329648	Aug 18, 2026	today	U-2590
8906851	Aug 18, 2026	today	U-2593
9884092	Aug 18, 2026	today	U-2593
8329648*PED	Feb 18, 2027	in 6 mo
8906851*PED	Feb 18, 2027	in 6 mo
9884092*PED	Feb 18, 2027	in 6 mo
8501698	Jun 20, 2027	in 10 mo	ProductU-2588
8501698*PED	Dec 20, 2027	in 1 yr 4 mo
8361972	Mar 21, 2028	in 1 yr 7 mo	U-2588
8361972*PED	Sep 21, 2028	in 2 yr 2 mo
8895033	Oct 04, 2030	in 4 yr 2 mo	ProductU-2597
8895033*PED	Apr 04, 2031	in 4 yr 8 mo

Approval history

FDA approval span

First approval

Apr 28, 2005

21 yr 7 mo ago

Most recent approval

Nov 19, 2024

1 yr 9 mo ago

Approvals span 2005–2024 across 4 FDA applications.

Brand (NDA) 375%

Generic (ANDA) 125%

Exenatide synthetic: 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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