Viewing data from:

BYDUREON BCISE

NDA

EXENATIDE SYNTHETIC | N209210 | ASTRAZENECA AB

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Expired (1)Expiring < 1yr (4)Active (2)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

Today

Apr. 4, 2026

Feb. 18, 2027

Sep. 21, 2028

Dec. 20, 2027

Apr. 4, 2031

Feb. 18, 2027

Feb. 18, 2027

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Bydureon Bcise (2023)

Total Spending

$284.1M

Total Claims

212,804

Beneficiaries

45,857

Avg Cost/Unit

$244.15

Spending Trend

$215.5M(2019)→$266.2M(2020)→$379.2M(2021)→$355.1M(2022)→$284.1M(2023)

YoY Change:+3.1%

5yr CAGR:+4.4%

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

18 letters from Drugs@FDA

Date	Submission	Document
May 29, 2025	SUPPL -25	View Letter (PDF)
Nov 5, 2024	SUPPL -24	View Letter (PDF)
Mar 12, 2024	SUPPL -23	View Letter (PDF)
Dec 22, 2022	SUPPL -22	View Letter (PDF)
Jul 27, 2022	SUPPL -19	View Letter (PDF)
Jun 14, 2022	SUPPL -21	View Letter (PDF)
Jul 26, 2021	SUPPL -17	View Letter (PDF)
Dec 3, 2020	SUPPL -14	View Letter (PDF)
Mar 3, 2020	SUPPL -11	View Letter (PDF)
Jul 26, 2019	SUPPL -2	View Letter (PDF)
Jul 26, 2019	SUPPL -8	View Letter (PDF)
Jul 26, 2019	SUPPL -7	View Letter (PDF)
Jul 26, 2019	SUPPL -6	View Letter (PDF)
Jul 26, 2019	SUPPL -5	View Letter (PDF)
Jul 26, 2019	SUPPL -4	View Letter (PDF)
Jul 26, 2019	SUPPL -3	View Letter (PDF)
Feb 21, 2019	SUPPL -1	View Letter (PDF)
Nov 27, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/0.85ML (2MG/0.85ML)

RLD

7 patents0 exclusivities▴

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Oct 20, 2017

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
6515117	Oct 4, 2025PED: Apr 4, 2026	PED	Yes	Yes	—
8329648	Aug 18, 2026PED: Feb 18, 2027	PED	—	—	—
8361972	Mar 21, 2028PED: Sep 21, 2028	PED	—	—	—
8501698	Jun 20, 2027PED: Dec 20, 2027	PED	—	—	—
8895033	Oct 4, 2030PED: Apr 4, 2031	PED	—	Yes	—
8906851	Aug 18, 2026PED: Feb 18, 2027	PED	—	—	—
9884092	Aug 18, 2026PED: Feb 18, 2027	PED	—	—	—