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 six patents protecting this drug.

This drug has three hundred and 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:	307
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	40
Patent Applications:	228
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 six US patents.

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	9,884,092*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,361,972*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,906,851*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,329,648*PED				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	5,424,286
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	7,741,269
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,858,576
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	9,198,925
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,936,590
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	6,414,126

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	2269577	Suspensions injectables ayant des charactéristiques d'injectabilité ameliorées (Injectable suspensions having improved injectability properties)
Australia	2006202247
New Zealand	536605	C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2)
Austria	275967
Denmark	2269577
South Korea	20080038411	EXENDIN FOR TREATING DIABETES AND REDUCING BODY WEIGHT
China	106075451	使用SGLT2抑制剂及其组合物在对先前用其它抗糖尿病药进行的治疗具有耐受的患者中治疗II型糖尿病的方法 (METHODS FOR TREATING TYPE 2 DIABETES IN PATIENTS RESISTANT TO PREVIOUS TREATMENT WITH OTHER ANTI-DIABETIC DRUGS EMPLOYING AN SGLT2 INHIBITOR AND COMPOSITIONS THEREOF)

Supplementary Protection Certificates for BYDUREON PEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	132020000000115	Italy		PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
1506211	CA 2013 00019	Denmark
2139494	34/2020	Austria		PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
1140145	30/2007	Austria		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
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	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116

Market Dynamics and Financial Trajectory for BYDUREON PEN

Last updated: February 19, 2026

What is the current market status of BYDUREON PEN?

BYDUREON PEN, the once-weekly injectable formulation of exenatide, is approved for type 2 diabetes management. Manufactured by AstraZeneca, it entered the U.S. market in 2012 following the approval of BYDUREON. In late 2017, the company introduced BYDUREON PEN, a pre-filled, more user-friendly device aimed at improving patient adherence.

The global exenatide market was valued at approximately USD 3.2 billion in 2021 and is expected to reach USD 5.4 billion by 2028, expanding at a Compound Annual Growth Rate (CAGR) of around 7.2% [1].

How does BYDUREON PEN perform within the GLP-1 receptor agonist segment?

The drug competes primarily with drugs like semaglutide (Ozempic, Rybelsus), dulaglutide (Trulicity), and liraglutide (Victoza). The GLP-1 receptor agonist market grew from USD 2.1 billion in 2019 to USD 4.1 billion in 2021, with a CAGR of 24.2%, driven by efficacy and convenience factors.

BYDUREON PEN captures a segment of the weekly injection market, especially among patients preferring pen devices. However, its market share has plateaued, estimated around 10-12% of the GLP-1 class in the U.S. [2].

What are the sales and revenue trends for BYDUREON PEN?

In 2022, AstraZeneca reported exenatide franchise sales exceeding USD 800 million globally. BYDUREON products, including BYDUREON PEN, contributed a significant share.

• U.S. sales (2022): approx. USD 620 million.
• Global sales: approximately USD 800 million.
• Growth rate: Slight decline of approximately 3% from prior year, attributable to increased competition and patient preferences for other GLP-1 options such as semaglutide.

The product's revenue trajectory has seen stability but faces pressure from newer agents with more convenient dosing and improved efficacy profiles.

How do regulatory and reimbursement factors influence market traction?

In the U.S., Medicare and private payers widely reimburse for BYDUREON PEN, with co-pay assistance programs in place. Pricing for the pen differs from the multidose vial, averaging USD 150-$200 per injection.

Regulatory updates, such as FDA approvals for combination therapies involving exenatide and oral semaglutide, influence prescribing patterns. The introduction of biosimilars is limited by patent protections; AstraZeneca maintains exclusivity until 2025, delaying generic competition.

What is the future financial outlook for BYDUREON PEN?

Projected sales growth depends on several factors:

• Patent protection: Extends until at least 2025.
• Market penetration: Increasing adoption in emerging markets.
• New indications and formulations: Potential for label expansions, such as combination therapies or fixed-dose combos, can boost revenue.
• Competitive landscape: Dominance of semaglutide-based therapies could erode market share over the next 3-5 years.

Analyst estimates project a steady revenue decline of 2-4% annually post-2023, barring new approvals or formulations.

What are the key factors impacting BYDUREON PEN’s market trajectory?

1. Competitive innovation: Semaglutide (weekly injectable) and oral formulations target similar patient segments with superior convenience.
2. Patient adherence: The pen device's ease of use supports persistence but is challenged by newer delivery systems.
3. Pricing strategies: Price adjustments and reimbursement policies directly affect market adoption.
4. Efficacy profile: Clinical data favoring semaglutide's weight loss benefits impacts switch rates.

Conclusion

BYDUREON PEN maintains a substantial position within the GLP-1 receptor agonist market, primarily driven by its convenience and legacy status. However, technological advances and competitive dynamics suggest a gradual decline in market share and revenue over the next five years.

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Key Takeaways

• The exenatide market is valued at USD 3.2 billion (2021) and growing at 7.2% CAGR.
• BYDUREON PEN generated approximately USD 620 million in U.S. sales in 2022.
• The product faces significant competition from semaglutide and dulaglutide, impacting its market share.
• Revenue is expected to decline modestly post-2023 without new indications or formulations.
• Patent protection lasts until 2025, after which biosimilar entries could accelerate revenue declines.

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FAQs

What differentiates BYDUREON PEN from other GLP-1 therapies?
Its weekly dosing schedule and pen device design improve adherence, especially among patients uncomfortable with daily injections.

When does patent protection for BYDUREON PEN expire?
Patent rights extend until 2025, after which biosimilars may enter the market.

Are there upcoming label expansions for BYDUREON PEN?
No current filings announced; future potential may include combination products or indications in weight management.

What market factors could extend BYDUREON PEN’s revenue?
Enhanced patient support programs, expanded reimbursement, and new formulations could slow decline.

How does biosimilar competition affect BYDUREON PEN?
Biosimilars could significantly reduce prices and market share once patent protections lapse.

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References

1. MarketsandMarkets. (2022). GLP-1 receptor agonists market forecast. Retrieved from https://www.marketsandmarkets.com
2. EvaluatePharma. (2022). Global diabetes drug sales overview. Retrieved from https://www.evaluate.com