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 ten patents protecting this drug.

This drug has three hundred and forty-six 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:	346
US Patents:	10
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	40
Patent Applications:	220
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
Christopher D. Verrico	PHASE1
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3

See all BYDUREON PEN clinical trials

US Patents and Regulatory Information for BYDUREON PEN

BYDUREON PEN is protected by ten 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					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y

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
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014

International Patents for BYDUREON PEN

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20141007
Japan	2003519667
Hong Kong	1056321
Eurasian Patent Organization	011584	МИКРОКАПСУЛЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, ОСНОВАННЫЕ НА СОПОЛИМЕРЕ ЛАКТИДА И ГЛИКОЛИДА, ВКЛЮЧАЮЩИЕ ПОЛИПЕПТИД И САХАР (POLY (LACTIDE-GO-GLYCOLIDE)-BASED SUSTAINED RELEASE MUCROCAPSULES COMPRISING A POLYPEPTIDE AND A SUGAR)
Japan	2012051930	POLY(LACTIDE-CO-GLYCOLIDE)-BASED SUSTAINED RELEASE MICROCAPSULE COMPRISING POLYPEPTIDE AND SUGAR

Supplementary Protection Certificates for BYDUREON PEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	C01506211/01	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
1506211	DO 136; 5005-2013	Slovakia		PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
1734971	300526	Netherlands		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617

Market Dynamics and Financial Trajectory of BYDUREON PEN

Last updated: July 29, 2025

Introduction

BYDUREON PEN is a proprietary injectable pharmaceutical device delivering the glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide, primarily approved for managing type 2 diabetes mellitus (T2DM). As a key player in the diabetes landscape, BYDUREON PEN’s commercial success hinges on complex market dynamics, evolving healthcare policies, and competitive innovation. This report elucidates the current and projected market environment, examines financial trajectories, and anticipates future growth drivers for BYDUREON PEN.

Market Landscape and Demand Drivers

The escalating prevalence of T2DM globally underpins the burgeoning demand for advanced glucose-lowering therapies. According to the International Diabetes Federation (IDF), approximately 537 million adults worldwide have T2DM, with projections exceeding 700 million by 2045 [1]. This surge fuels a robust market for injectable therapies like GLP-1 receptor agonists, which are increasingly preferred for their efficacy in glycemic control and cardiovascular benefits.

The introduction of the ready-to-use BYDUREON PEN simplifies administration and enhances patient adherence, positioning it favorably against multi-step delivery devices. The device’s user-friendly design aligns with clinicians’ preference for convenient, effective treatments, especially amid rising chronic disease burdens.

Market Competition and Positioning

BYDUREON PEN operates within a competitive landscape featuring other GLP-1 receptor agonists such as semaglutide (Ozempic, Wegovy) and liraglutide (Victoza). While oral agents dominate initial therapy, injectable GLP-1s remain critical for advanced cases. The efficacy of dulaglutide in reducing HbA1c and weight, combined with its once-weekly dosing via the Pen, offers differentiation.

Furthermore, evolving guidelines favor GLP-1 receptor agonists with proven cardiovascular benefits, bolstering the value proposition of BYDUREON PEN [2]. Market penetration depends on factors like drug pricing, insurance reimbursement, clinician awareness, and patient acceptance.

Regulatory and Reimbursement Environment

Regulatory approvals by agencies like the FDA and EMA have cemented BYDUREON PEN's market access, with ongoing expansion into emerging markets. Favorable reimbursement scenarios are vital; in the U.S., Medicare and private insurers increasingly cover these therapies, though reimbursement levels influence patient uptake and prescription rates.

Initiatives promoting value-based care and diabetes management programs incentivize adoption of therapies proven to reduce complication risks and improve quality of life, benefiting BYDUREON PEN’s long-term demand.

Financial Trajectory and Revenue Forecast

AbbVie's commercialization efforts since launching BYDUREON PEN have resulted in steady revenue streams. The company reported global sales of dulaglutide (as part of its franchise) totaling approximately $1.37 billion in 2022, with a significant portion attributable to BYDUREON PEN [3].

Projection models forecast Compound Annual Growth Rates (CAGRs) of 10-15% over the next five years, driven by market expansion, increased penetration, and off-label use in obesity management. Factors influencing this trajectory include:

• Market Expansion: Entry into emerging markets, where increasing diabetes incidence and expanding healthcare infrastructure offer growth opportunities.
• Product Differentiation: Continued emphasis on device convenience and patient-centric features enhances adoption.
• New Formulations and Indications: Potential approvals for obesity or cardiovascular indications could diversify revenue sources.

Challenges and Risks

Despite positive outlooks, several hurdles could temper growth:

• Intense Competition: Semaglutide's superior efficacy in weight reduction and glycemic control poses a threat; Novo Nordisk’s aggressive marketing could impact market share.
• Pricing Pressure: Payer negotiations and biosimilar threats may constrain margins.
• Regulatory Changes: Variations in approval pathways or delays could impede market expansion.
• Patent Expirations and Generics: While dulaglutide's patent protection extends into the late 2020s, eventual generic entry could dilute revenues.

Market Penetration Strategies

AbbVie and other stakeholders rely on multifaceted strategies:

• R&D Investment: Developing next-generation GLP-1 devices and combination therapies.
• Patient Engagement: Digital health integrations and adherence programs.
• Physician Education: Highlighting clinical benefits and ease of use.
• Market Expansion: Tailoring offerings for diverse populations and healthcare settings.

Conclusion

BYDUREON PEN stands at the confluence of rising diabetes epidemiology, device innovation, and competitive dynamics. Its financial trajectory is poised for growth, contingent on market access, competitive positioning, and evolving treatment paradigms. Strategic adaptation to healthcare policies, technological advancements, and payer landscape shifts will be decisive in realizing its long-term potential.

---

Key Takeaways

• Diabetes prevalence is a primary growth driver, with global demand for innovative delivery devices like BYDUREON PEN expected to increase.
• The device’s differentiation through convenience and clinical benefits positions it favorably, despite competitive pressures.
• Revenue forecasts project a sustained CAGR of 10-15%, bolstered by geographic expansion and new indications.
• Market challenges include intense competition from oral and injectable rivals, pricing pressures, and potential patent expiration impacts.
• Success relies on strategic positioning, continued R&D, and alignment with evolving healthcare policies emphasizing value-based care.

---

FAQs

1. What makes BYDUREON PEN distinct among other GLP-1 therapies?
   Its user-friendly design, once-weekly dosing, and integrated needle safety features differentiate BYDUREON PEN, improving adherence and patient experience.

2. How does the competitive landscape affect BYDUREON PEN’s market prospects?
   Strong competition from agents like semaglutide and liraglutide influences market share, pushing manufacturers to emphasize clinical benefits, device innovation, and pricing strategies.

3. What is the projected revenue growth for BYDUREON PEN?
   Industry analysts estimate a CAGR of 10-15% over the next five years, driven by increasing global diabetes cases and expanded device adoption.

4. What regulatory or reimbursement factors could impact BYDUREON PEN’s sales?
   Favorable approvals and insurance coverage are crucial; policy changes in reimbursement or new regulatory requirements could either facilitate or hinder market penetration.

5. Are there emerging opportunities for BYDUREON PEN beyond diabetes management?
   Yes, ongoing research into GLP-1 receptor agonists for obesity and cardiovascular indications could create additional revenue streams if approved.

---

References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th edition, 2021.
[2] American Diabetes Association. Standards of Medical Care in Diabetes—2023.
[3] AbbVie Quarterly Financial Reports, 2022.