Exenatide - PharmaKB

Byetta(exenatide)

Bydureon, Byetta, Exenatide Synthetic (exenatide) is a protein pharmaceutical. Exenatide was first approved as Byetta on 2005-04-28. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against glucagon-like peptide 1 receptor.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700

Trade Name

FDA

EMA

Exenatide synthetic (discontinued: Bydureon, Byetta)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Exenatide synthetic

Tradename	Company	Number	Date	Products
BYDUREON	AstraZeneca	N-022200 DISCN	2012-01-27	1 products, RLD
BYDUREON PEN	AstraZeneca	N-022200 DISCN	2014-02-28	1 products, RLD
BYETTA	AstraZeneca	N-021773 DISCN	2005-04-28	2 products, RLD
BYDUREON BCISE	AstraZeneca	N-209210 DISCN	2017-10-20	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
bydureon bcise	New Drug Application	2024-11-01
byetta	New Drug Application	2024-11-01
exenatide	ANDA	2024-11-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
type 2 diabetes mellitus	EFO_0001360	D003924	E11

Agency Specific

FDA

EMA

Expiration	Code
EXENATIDE SYNTHETIC, BYDUREON, ASTRAZENECA AB
2025-01-22	PED
2024-07-22	NPP
EXENATIDE SYNTHETIC, BYDUREON BCISE, ASTRAZENECA AB
2025-01-22	PED
2024-07-22	NPP
EXENATIDE SYNTHETIC, BYDUREON PEN, ASTRAZENECA AB
2025-01-22	PED
2024-07-22	NPP
EXENATIDE SYNTHETIC, BYETTA, ASTRAZENECA AB
2024-11-04	M-232

Patent Expiration

Patent	Expires	Flag	FDA Information
Exenatide Synthetic, Bydureon Bcise, Astrazeneca Ab
8895033	2030-10-04	DP	U-2589, U-2590, U-2597, U-2601, U-2602, U-3188, U-3189, U-3190
Exenatide Synthetic, Bydureon, Astrazeneca Ab
8361972	2028-03-21		U-2588
8501698	2027-06-20	DP	U-2588
8329648	2026-08-18		U-2588, U-2589, U-2590, U-2593, U-2594, U-2595, U-2596, U-3188, U-3189, U-3190
8906851	2026-08-18		U-2588, U-2589, U-2590, U-2593, U-2597, U-3188, U-3189, U-3190
9884092	2026-08-18		U-2588, U-2589, U-2590, U-2593, U-2594, U-2595, U-2596, U-2597, U-3188, U-3189, U-3190
6515117	2025-10-04	DS, DP	U-2588
7456254	2025-06-30	DP	U-2588, U-2589, U-2590, U-3188, U-3189, U-3190
7612176	2025-04-13	DP	U-2588, U-2589, U-2590, U-3188, U-3189, U-3190
8431685	2025-04-13	DP	U-2588, U-2589, U-2590, U-2597, U-3188, U-3189, U-3190
8461105	2025-04-13	DP	U-2588, U-2589, U-2590, U-2597, U-3188, U-3189, U-3190

ATC Codes

A: Alimentary tract and metabolism drugs

— A10: Drugs used in diabetes

— A10B: Blood glucose lowering drugs, excl. insulins

— A10BJ: Glucagon-like peptide-1 (glp-1) analogues

— A10BJ01: Exenatide

HCPCS

No data

Clinical

No data

Drug

General

Drug common name	Exenatide
INN	exenatide
Description	EXENATIDE
Classification	Protein
Drug class	peptides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O

Identifiers

PDB	—
CAS-ID	141758-74-9
RxCUI	—
ChEMBL ID	CHEMBL414357
ChEBI ID	—
PubChem CID	16157882
DrugBank	DB01276
UNII ID	9P1872D4OL (ChemIDplus, GSRS)

Target

Agency Approved

GLP1R

Organism

Homo sapiens

Gene name

GLP1R

Gene synonyms

NCBI Gene ID

2740

Protein name

glucagon-like peptide 1 receptor

Protein synonyms

GLP-1 receptor, GLP1 receptor, seven transmembrane helix receptor

Uniprot ID

Q99669

Mouse ortholog

Glp1r (14652)

glucagon-like peptide 1 receptor (Q1JQR8)

Alternate

No data

Variants

No data

Financial

Revenue by drug

€

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Bydureon – Alkermes

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Bydureon – AstraZeneca

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Bydureon – Bristol Myers Squibb

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Exenatide – Eli Lilly

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Byetta – Amylin Pharmaceuticals

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Byetta – AstraZeneca

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Byetta – Bristol Myers Squibb

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Estimated US medical usage

Exenatide

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Trends

No data

Safety

Black-box Warning

Black-box warning for: Bydureon bcise

Adverse Events

0 adverse events reported