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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 thirteen patents protecting this drug.

This drug has four hundred and eight patent family members in forty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Bydureon Bcise

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 4, 2031. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BYDUREON BCISE

International Patents:	408
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	39
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
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3
Dasman Diabetes Institute	Phase 4

See all BYDUREON BCISE clinical trials

Pharmacology for BYDUREON BCISE

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

US Patents and Regulatory Information for BYDUREON BCISE

BYDUREON BCISE is protected by thirteen 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		RX	Yes	Yes	7,563,871*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,895,033*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,329,648*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	6,515,117*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,906,851*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	7,612,176*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	6,956,026
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	6,936,590
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	6,479,065

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

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
Hong Kong	1066465
European Patent Office	1032587	NOUVEAUX COMPOSES AGONISTES DE L'EXENDINE (NOVEL EXENDIN AGONIST COMPOUNDS)
Serbia	99204	C-ARIL GLUKOZID SGLT2 INHIBITORI I POSTUPAK (S-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD)
China	104230866	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD
Poland	1734971
China	1968700	Polymer-based sustained release device
Slovenia	2069374

Supplementary Protection Certificates for BYDUREON BCISE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	CA 2007 00034	Denmark
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	92182	Luxembourg		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2139494	C20200028 00358	Estonia		PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
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
1506211	13C0022	France		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112

BYDUREON BCISE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BYDUREON BCise

Introduction

BYDUREON BCise, an exenatide extended-release formulation, is a significant player in the incretin mimetics market, particularly for the treatment of type 2 diabetes. This article delves into the market dynamics and financial trajectory of BYDUREON BCise, highlighting its performance, challenges, and future prospects.

Market Context: Incretin Mimetics

The global incretin mimetics market is projected to grow from $21.8 billion in 2023 to $35.2 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 4.9%[3].

Dominant Segment

Exenatide, the active ingredient in BYDUREON BCise, held a market share of 27.4% in 2023, making it a leading drug in the incretin mimetics segment[3].

Application and Distribution

Type 2 diabetes mellitus is the dominant application segment, accounting for 62.3% of the market share. Hospital pharmacies are the leading distribution channel, indicating a strong presence in clinical settings[3].

Product Approval and Expansion

Initial Approval

BYDUREON BCise was first approved in the US in October 2017 as a once-weekly single-dose autoinjector device for adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines, in addition to diet and exercise[4].

Pediatric Approval

In July 2021, the US FDA approved BYDUREON BCise for pediatric patients aged 10 to 17 with type 2 diabetes, marking a significant expansion of its indication. This approval provided a convenient, once-weekly treatment option for a younger demographic[4].

Financial Performance: Challenges and Impact

Production Constraints

In 2019, AstraZeneca faced production constraints with the new Bydureon Bcise device, leading to a 7% decline in sales over the first nine months of the year. Despite efforts to resolve these constraints, the third quarter saw a 16% drop in global sales, largely due to a downturn in US sales[1].

Regional Performance

The decline in Bydureon sales was more pronounced in Europe and other established markets, with declines of 14% and 25%, respectively, over the first nine months of 2019. However, growth in other parts of AstraZeneca’s biopharmaceuticals business, such as the cardiovascular, renal, and metabolism (CVRM) unit, helped mitigate the impact[1].

Current Financial Trajectory

Overall Revenue

In the full-year 2023 results, AstraZeneca reported total revenue of $45,811 million, up 6% despite a decline from COVID-19 medicines. Excluding COVID-19 medicines, total revenue increased by 15%, and product sales increased by 14%[2].

Segment Performance

The CVRM business, which includes Bydureon Bcise, saw significant growth. Total revenue from the CVRM segment increased by 18%, driven by strong demand for other products like Brilinta and Farxiga in emerging markets[2].

Market Dynamics and Growth Drivers

Macroeconomic and Geopolitical Factors

The incretin mimetics market is influenced by macroeconomic and geopolitical factors. Economic expansion in developed regions increases healthcare spending, while inflationary pressures and trade disruptions can impact production costs and supply chains[3].

Regional Growth

The Asia Pacific region is expected to experience the highest CAGR during the forecast period due to the rising incidence of type 2 diabetes and expanding healthcare infrastructure. Government initiatives and advancements in drug formulation technologies are expected to support market growth[3].

Competitive Landscape

Innovations and Clinical Trials

The market is driven by innovations and clinical trials. For example, Sanofi’s efpeglenatide, a once-weekly GLP-1 receptor agonist, has shown promising results, indicating a competitive landscape where companies are investing heavily in new treatments[3].

Key Takeaways

• Market Growth: The incretin mimetics market, led by exenatide, is expected to grow significantly, driven by increasing healthcare expenditures and the adoption of advanced diabetes management therapies.
• Product Expansion: BYDUREON BCise’s approval for pediatric patients has expanded its market reach and addressed a previously unmet need.
• Financial Performance: Despite initial production constraints, AstraZeneca’s CVRM segment has shown strong growth, driven by other successful products.
• Regional Dynamics: The Asia Pacific region is poised for the highest growth due to rising diabetes incidence and healthcare infrastructure expansion.

FAQs

1. What is BYDUREON BCise? BYDUREON BCise is an exenatide extended-release formulation used as a once-weekly single-dose autoinjector device for the treatment of type 2 diabetes.

2. What were the production constraints faced by BYDUREON BCise? In 2019, AstraZeneca faced production constraints with the new Bydureon Bcise device, leading to a decline in sales.

3. How has BYDUREON BCise’s indication expanded? BYDUREON BCise was approved for pediatric patients aged 10 to 17 with type 2 diabetes in July 2021, expanding its market reach.

4. What are the key drivers of the incretin mimetics market? The market is driven by increasing healthcare expenditures, adoption of advanced diabetes management therapies, and government initiatives aimed at improving diabetes management.

5. Which region is expected to experience the highest CAGR in the incretin mimetics market? The Asia Pacific region is expected to experience the highest CAGR due to the rising incidence of type 2 diabetes and expanding healthcare infrastructure.

Sources

1. Outsourcing-pharma: AstraZeneca sales hurt by Bydureon Bcise production constraints.
2. AstraZeneca: Full-year and Q4 2023 results announcement.
3. Market.us: Incretin Mimetics Market Size, Share | CAGR Of 4.9%.
4. AstraZeneca-US: BYDUREON BCise (exenatide extended-release) approved in the US for the treatment of type 2 diabetes.