BYDUREON PEN Drug Patent Profile

Which patents cover Bydureon Pen, and what generic alternatives are available?

Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eighteen patents protecting this drug.

This drug has three hundred and seventy-seven patent family members in forty-eight countries.

The generic ingredient in BYDUREON PEN is exenatide synthetic. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bydureon Pen

A generic version of BYDUREON PEN was approved as exenatide synthetic by AMNEAL on November 19^th, 2024.

Summary for BYDUREON PEN

International Patents:	377
US Patents:	18
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Drug Prices:	Drug price information for BYDUREON PEN
DailyMed Link:	BYDUREON PEN at DailyMed

See drug prices for BYDUREON PEN

Recent Clinical Trials for BYDUREON PEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3
Dasman Diabetes Institute	Phase 4

See all BYDUREON PEN clinical trials

US Patents and Regulatory Information for BYDUREON PEN

BYDUREON PEN is protected by eighteen US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,431,685*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,758,292*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,690,837*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	7,456,254*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No

Expired US Patents for BYDUREON PEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,956,026
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,872,700
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,479,065
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,495,164
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	5,424,286
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,936,590

International Patents for BYDUREON PEN

See the table below for patents covering BYDUREON PEN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1734971	DISPOSITIF À LIBÉRATION CONTRÔLÉE À BASE DE POLYMÈRE (POLYMER-BASED SUSTAINED RELEASE DEVICE)
Georgia, Republic of	P20084403	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD
Japan	2003519667
Mexico	2009010155	FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE.)
Spain	2536235
Spain	2950089

Supplementary Protection Certificates for BYDUREON PEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	588	Finland
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211	C20140021 00131	Estonia		PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211	CR 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1140145	SZ 30/2007	Austria		PRODUCT NAME: EXENATIDE

Market Dynamics and Financial Trajectory for the Bydureon Pen

Introduction

The Bydureon Pen, developed by AstraZeneca, is a significant player in the treatment of type 2 diabetes, particularly as a once-weekly GLP-1 receptor agonist. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its evolution, market impact, and future prospects.

Market Context: Diabetic Pens Market

The diabetic pens market is experiencing robust growth, driven primarily by the increasing prevalence of diabetes globally. This market is expected to grow by USD 3.41 billion during 2020-2024, with a CAGR of over 8%[1].

Product Evolution of Bydureon

Bydureon, initially introduced as Byetta in 2005, was the first GLP-1 receptor agonist to hit the market. Over the years, it has undergone significant transformations:

• From Byetta to Bydureon: Bydureon was launched in 2012 as a once-weekly therapy, marking a significant advancement over the twice-daily Byetta.
• Formulation Changes: The drug has transitioned from a formulation that required users to mix ingredients and assemble the syringe to a more convenient auto-injector device, enhancing user experience[4].

Clinical Trials and Regulatory Approvals

Recent clinical trials have been pivotal in expanding the use of Bydureon:

• Trial in Children and Adolescents: Bydureon BCise became the first once-a-week GLP-1 med to complete a trial in children and adolescents with type 2 diabetes, showing promising results in reducing A1C levels and body weight[4].
• Regulatory Prospects: The successful trial outcomes are expected to pave the way for FDA approval, potentially opening up a new market segment for Bydureon.

Market Performance and Competition

Despite its innovative features, Bydureon faces intense competition in the GLP-1 market:

• Sales Trends: Sales of Bydureon and its predecessor Byetta have been in decline due to competition from other GLP-1 receptor agonists such as Eli Lilly's Trulicity, Merck’s Januvia, and Novo Nordisk’s Victoza and Ozempic[4].
• Competitive Landscape: The GLP-1 market is highly competitive, with multiple players offering similar or superior products, which has impacted Bydureon’s market share.

Financial Performance of AstraZeneca

AstraZeneca’s overall financial performance provides context for the Bydureon Pen’s financial trajectory:

• Revenue Growth: AstraZeneca has reported strong revenue growth, with total revenue increasing by 25% in 2022, driven by its oncology, cardiovascular, renal, and metabolism (CVRM), and rare disease segments[2].
• Segment Performance: While Bydureon is part of the CVRM segment, the segment's growth is more broadly driven by other products. The CVRM segment saw a 19% increase in total revenue in 2022[2].

Specific Financials for Bydureon

The financial performance of Bydureon is intertwined with AstraZeneca’s broader diabetes franchise:

• Declining Sales: The sales of Bydureon and Byetta have been declining due to competitive pressures, despite the innovative advancements and clinical trial successes[4].
• Revenue Contribution: Although specific revenue figures for Bydureon are not isolated, the decline in sales of these drugs has been offset by the growth in other segments within AstraZeneca.

Future Prospects

Despite current challenges, Bydureon has several future prospects that could revitalize its market position:

• New Market Segments: The approval for use in children and adolescents could open up a new and underserved patient population, potentially boosting sales[4].
• Continuous Innovation: AstraZeneca’s commitment to R&D and the introduction of more convenient and user-friendly delivery systems could enhance Bydureon’s appeal in the market.

Key Takeaways

• Market Growth: The diabetic pens market is growing, driven by the increasing prevalence of diabetes.
• Product Evolution: Bydureon has evolved significantly from its initial form as Byetta to a more convenient once-weekly auto-injector.
• Clinical Trials: Successful trials in children and adolescents could lead to new regulatory approvals and market opportunities.
• Financial Performance: Despite declining sales, AstraZeneca’s overall financial health and commitment to R&D suggest potential for future growth.
• Competitive Landscape: The GLP-1 market is highly competitive, but innovation and new market segments could help Bydureon regain market share.

FAQs

1. What is the current market trend for diabetic pens? The diabetic pens market is expected to grow by USD 3.41 billion during 2020-2024, with a CAGR of over 8%, driven by the increasing prevalence of diabetes[1].

2. How has Bydureon evolved since its introduction? Bydureon evolved from Byetta, the first GLP-1 receptor agonist, to a once-weekly therapy and then to a more convenient auto-injector device[4].

3. What are the recent clinical trial outcomes for Bydureon? Bydureon BCise completed a trial in children and adolescents with type 2 diabetes, showing significant reductions in A1C levels and body weight[4].

4. How does Bydureon compete in the GLP-1 market? Bydureon faces intense competition from other GLP-1 receptor agonists like Trulicity, Januvia, Victoza, and Ozempic, which has impacted its sales[4].

5. What are the future prospects for Bydureon? Future prospects include potential FDA approval for use in children and adolescents, and continuous innovation in delivery systems, which could boost its market position[4].

Sources

1. Technavio - Global Diabetic Pens Market 2020-2024[1]
2. AstraZeneca - Full year and Q4 2022 results announcement[2]
3. Seeking Alpha - Bydureon Physician Survey: Results Yield Insight Into Launch Trajectory[3]
4. FiercePharma - ADA 2021: AstraZeneca touts Bydureon trial win in children and adolescents with type 2 diabetes[4]
5. AstraZeneca - Full year and Q4 2023 results announcement[5]