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Last Updated: December 24, 2024

bydureon pen Drug Patent Profile


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When do Bydureon Pen patents expire, and when can generic versions of Bydureon Pen launch?

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

This drug has four hundred and eight 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. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

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Summary for bydureon pen
Drug patent expirations by year for bydureon pen
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Recent Clinical Trials for bydureon pen

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SponsorPhase
The University of Texas Health Science Center, HoustonPhase 2
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4

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US Patents and Regulatory Information for bydureon pen

bydureon pen is protected by twenty 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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Subscribe ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Subscribe ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Subscribe ⤷  Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for bydureon pen

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 PA2020522 Lithuania ⤷  Subscribe PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
2139494 34/2020 Austria ⤷  Subscribe PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
1140145 30/2007 Austria ⤷  Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120
1734971 2012C/017 Belgium ⤷  Subscribe PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
2139494 132020000000115 Italy ⤷  Subscribe PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Bydureon pen Market Analysis and Financial Projection Experimental

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]

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