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BYETTA

NDA

EXENATIDE SYNTHETIC | N021773 | ASTRAZENECA AB

2 strengths0 unique patents0 unique exclusivities

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca Pharmaceuticals LP et al v. Amneal Pharmaceuticals LLC et al 1:2015cv01139 2 patentsANDA 206697exenatide	D. Del.	2015-12-09	Terminated 2017-09-21	—
Teva Pharmaceuticals USA Inc. v. AstraZeneca Pharmaceuticals LP et al 1:2015cv00050 8 patentsANDA 205984Exenatide	D. Del.	2015-01-19	Terminated 2016-09-28	—
AstraZeneca Pharmaceuticals LP et al v. Teva Pharmaceuticals USA Inc. 1:2014cv01478 8 patentsANDA 205984exenatide	D. Del.	2014-12-12	Terminated 2016-06-27	—

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 Byetta (2023)

Total Spending

$20.6M

Total Claims

14,042

Beneficiaries

3,396

Avg Cost/Unit

$442.15

Spending Trend

$61.4M(2019)→$47.7M(2020)→$38.0M(2021)→$27.5M(2022)→$20.6M(2023)

YoY Change:+4.7%

5yr CAGR:+4.2%

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

API Supply Chain6 active DMFs1 inactive

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

BACHEM AMERICAS INCEXENATIDE (BULK)

DMF 172272004

TAPI NL BVEXENATIDE

DMF 271232013

SUN PHARMACEUTICAL INDUSTRIES LTDEXENATIDE

DMF 298632015

POLYPEPTIDE LABORATORIES SWEDEN ABEXENATIDE USP

DMF 309242016

MSN LIFE SCIENCES PRIVATE LTDEXENATIDE USP

DMF 345662020

ALP PHARM BEIJING CO LTDEXENATIDE

DMF 354762020

SPECGX LLCInactiveEXENATIDE

DMF 171142004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

30 letters from Drugs@FDA

Date	Submission	Document
Sep 3, 2025	SUPPL -51	View Letter (PDF)
May 29, 2025	SUPPL -50	View Letter (PDF)
Nov 5, 2024	SUPPL -49	View Letter (PDF)
Dec 22, 2022	SUPPL -48	View Letter (PDF)
Jun 13, 2022	SUPPL -46	View Letter (PDF)
Jun 13, 2022	SUPPL -47	View Letter (PDF)
Nov 5, 2021	SUPPL -45	View Letter (PDF)
Jun 22, 2021	SUPPL -44	View Letter (PDF)
Mar 3, 2020	SUPPL -43	View Letter (PDF)
Feb 27, 2015	SUPPL -40	View Letter (PDF)
Nov 26, 2014	SUPPL -36	View Letter (PDF)
Oct 24, 2011	SUPPL -29	View Letter (PDF)
Oct 24, 2011	SUPPL -30	View Letter (PDF)
Aug 10, 2011	SUPPL -31	View Letter (PDF)
Nov 18, 2010	SUPPL -28	View Letter (PDF)
Aug 20, 2010	SUPPL -26	View Letter (PDF)
Nov 18, 2009	SUPPL -18	View Letter (PDF)
Nov 18, 2009	SUPPL -9	View Letter (PDF)
Nov 18, 2009	SUPPL -11	View Letter (PDF)
Nov 18, 2009	SUPPL -22	View Letter (PDF)
Nov 18, 2009	SUPPL -17	View Letter (PDF)
Nov 18, 2009	SUPPL -25	View Letter (PDF)
Jun 20, 2008	SUPPL -10	View Letter (PDF)
Jan 18, 2008	SUPPL -12	View Letter (PDF)
Feb 23, 2007	SUPPL -7	View Letter (PDF)
Jan 8, 2007	SUPPL -2	View Letter (PDF)
Jan 8, 2007	SUPPL -6	View Letter (PDF)
Nov 6, 2006	SUPPL -5	View Letter (PDF)
Oct 18, 2006	SUPPL -4	View Letter (PDF)
May 3, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 300MCG/1.2ML (250MCG/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Apr 28, 2005

No patent or exclusivity listings for this strength.

#002 — 600MCG/2.4ML (250MCG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Apr 28, 2005