BYDUREON BCISE Drug Patent Profile

When do Bydureon Bcise patents expire, and what generic alternatives are available?

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

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

The generic ingredient in BYDUREON BCISE 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 Bcise

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

Summary for BYDUREON BCISE

International Patents:	378
US Patents:	11
Applicants:	1
NDAs:	1
Clinical Trials:	40
Drug Prices:	Drug price information for BYDUREON BCISE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYDUREON BCISE
What excipients (inactive ingredients) are in BYDUREON BCISE?	BYDUREON BCISE excipients list
DailyMed Link:	BYDUREON BCISE at DailyMed

See drug prices for BYDUREON BCISE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BYDUREON BCISE

Constraining patent/regulatory exclusivity:

8,895,033*PED

NDA:

209210

Dosage:

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BYDUREON BCISE

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

Sponsor	Phase
Christopher D. Verrico	PHASE1
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3

See all BYDUREON BCISE clinical trials

US Patents and Regulatory Information for BYDUREON BCISE

BYDUREON BCISE is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,895,033.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	7,612,176*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	8,906,851*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	8,431,685*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	9,884,092*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	7,456,254*PED				Y

Expired US Patents for BYDUREON BCISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	7,741,269
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,414,126
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	9,198,925
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,956,026
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,872,700
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,936,590

International Patents for BYDUREON BCISE

When does loss-of-exclusivity occur for BYDUREON BCISE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

San Marino

Singapore

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYDUREON BCISE around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	035999
Portugal	2508188
Slovenia	3466412
Mexico	2008015377
Norway	347770
Israel	214180

Supplementary Protection Certificates for BYDUREON BCISE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1734971	2012C/017	Belgium		PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
1506211	2013/013	Ireland		PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
0996459	CA 2007 00034	Denmark
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1506211	588	Finland
1734971	91989	Luxembourg		91989, EXPIRES: 20260617

Market Dynamics and Financial Trajectory for BYDUREON BCISE

Last updated: July 30, 2025

Introduction

BYDUREON BCISE, a once-weekly GLP-1 receptor agonist developed for type 2 diabetes management, represents a significant advancement in diabetes therapeutics. Manufactured by AstraZeneca and its partner Daiichi Sankyo, this injectable medication builds on the legacy of BYDUREON, with enhanced delivery systems and improved patient adherence. Understanding the evolving market dynamics and financial trajectory of BYDUREON BCISE is crucial for stakeholders, including investors, healthcare providers, and regulatory bodies navigating the competitive landscape of diabetes treatments.

Market Overview

Global Diabetes Drug Market

The global diabetes therapeutics market is projected to reach approximately $115 billion by 2027, growing at a compound annual growth rate (CAGR) of around 8.2% (2022–2027) [1]. Increasing prevalence of type 2 diabetes, driven by sedentary lifestyles, obesity, and aging populations, fuels demand for advanced treatment options.

Positioning of GLP-1 Receptor Agonists

GLP-1 receptor agonists, such as BYDUREON BCISE, have gained prominence due to their efficacy in glycemic control and positive cardiovascular outcomes [2]. They are increasingly preferred over traditional therapies like insulin or sulfonylureas for their added benefits, including weight reduction and lower hypoglycemia risk.

Market Dynamics Influencing BYDUREON BCISE

Competitive Landscape

The GLP-1 class includes drugs like Eli Lilly's Trulicity, Novo Nordisk’s Ozempic, and Wegovy. Trulicity is a direct competitor, with a significant market presence due to early entry and established reputation. Ozempic, with its broader indications including weight management, commands a substantial share.

Despite intense competition, BYDUREON BCISE distinguishes itself through its unique BCISE delivery system, offering improved patient satisfaction. However, maintaining market share requires continuous innovation and favorable pricing strategies amidst aggressive marketing by rivals.

Regulatory Environment

Regulatory agencies like the FDA have approved multiple GLP-1 therapies, often aligning their labeling for cardiovascular benefits. Recent approvals for indications such as weight management expand market opportunities. Regulatory pathways are becoming more streamlined for combination therapies and formulations aimed at improved adherence.

Healthcare Policy & Reimbursement

Reimbursement policies significantly influence product adoption. The high cost of GLP-1 agents poses barriers; coverage expansion and value-based pricing are vital for growth. Payer negotiations, especially in cost-conscious markets like the U.S., affect sales volume and revenue generation.

Patient Adherence & Compliance

The once-weekly administration of BYDUREON BCISE enhances adherence compared to daily injections. Data suggest improved compliance translates into better clinical outcomes and, consequently, stronger prescription retention. This factor is critical in the highly competitive diabetes market where persistence impacts drug success.

Technological and Formulation Innovations

Advancements such as the BCISE delivery system aim to minimize adverse effects like gastrointestinal discomfort and improve ease of use. Ongoing R&D investments ensure products remain competitive and aligned with patient preferences.

Financial Trajectory

Revenue Streams & Growth Potential

Since its launch, BYDUREON BCISE has experienced steady revenue growth. In 2021, AstraZeneca reported GLP-1 class sales exceeding $6 billion globally, with BYDUREON BCISE contribution growing proportionally [3]. The drug’s potential expansion into weight management markets underpinned by positive clinical trial data can significantly boost revenues.

Market Penetration Strategies

AstraZeneca leverages strategic partnerships and direct physician outreach to increase adoption. Expansion into emerging markets, where diabetes prevalence surges, presents revenue opportunities. Local regulatory approvals and market access will be decisive in capturing these newer segments.

Pricing & Reimbursement Impact

Premium pricing remains viable owing to clinical benefits and cardiovascular risk reduction. However, reimbursement restrictions could constrain access, impacting volume sales. Engagement with payers to demonstrate long-term cost savings is essential for sustained financial performance.

Profitability Outlook

Given the high R&D costs upstream, the profitability trajectory hinges on continued sales growth and market penetration. Economies of scale benefit gross margins, while strategic cost management optimizes operating profit margins. The upcoming patent expiration of key formulations may introduce generic challenges, though patent extensions or new formulations could mitigate this risk.

Future Growth Catalysts

• Indication Expansion: Regulatory filings for additional indications such as obesity and cardiovascular disease management can diversify revenue streams.
• Formulation Innovations: Development of oral formulations or more patient-friendly delivery systems could expand usage.
• Combination Therapies: Synergies with other anti-diabetic agents may unlock higher value segments.

Challenges & Risks

• Price Competition: Effective pricing strategies are crucial amid generic competition and payer pressure.
• Market Saturation: As adoption stabilizes, maintaining growth momentum may require innovation and expanding indications.
• Regulatory Hurdles: Delays or unfavorable outcomes in approvals can impact forecasted revenues.
• Patient Preference Shift: Emerging oral GLP-1 therapies could favor non-injectable options, challenging injectable drugs’ market share.

Conclusions

BYDUREON BCISE stands at a strategic crossroads shaped by fierce competition, evolving regulatory landscapes, and demographic shifts in diabetes prevalence. Its financial trajectory appears promising, buoyed by innovation, increased global reach, and expanding indications. Nevertheless, sustained success demands brands like BYDUREON BCISE to continually adapt through technological advancements, strategic pricing, and targeted market expansion.

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Key Takeaways

• The global GLP-1 receptor agonist market is expanding rapidly, with BYDUREON BCISE poised to benefit from increasing diabetes prevalence.
• Competitive differentiation hinges on delivery innovation, adherence improvement, and embracing broader indications, including obesity.
• Reimbursement and pricing strategies are pivotal; overcoming payer barriers will be essential for market penetration.
• Future growth relies on indication expansion, formulation innovation, and emerging markets’ entry.
• Ongoing R&D investments and strategic collaborations will sustain profitability and competitive advantage.

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FAQs

1. What differentiates BYDUREON BCISE from other GLP-1 therapies?
   Its unique BCISE delivery system offers once-weekly administration with enhanced patient comfort and improved adherence, setting it apart from competitors with daily or less patient-friendly formulations.

2. How does the competitive landscape affect BYDUREON BCISE’s prospects?
   Intense competition from entrenched players like Trulicity and Ozempic necessitates ongoing innovation, strategic marketing, and value demonstration to maintain market share.

3. What are the key regulatory considerations for BYDUREON BCISE?
   Regulatory approvals for additional indications and formulations, and navigating reimbursement policies, are critical to expanding its market footprint and ensuring financial growth.

4. How does reimbursement impact BYDUREON BCISE’s market adoption?
   High drug costs influence payer decisions; demonstrating long-term cost savings through cardiovascular and glycemic benefits is vital for wider coverage and affordability.

5. What growth opportunities exist beyond diabetes treatment?
   Leveraging clinical data for obesity and cardiovascular indications, along with developing oral or combination formulations, can diversify revenue streams.

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References

[1] Market Research Future, "Global Diabetes Therapeutics Market," 2022.
[2] American Diabetes Association, "Standards of Medical Care in Diabetes—2022."
[3] AstraZeneca Annual Report, 2021.