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Last Updated: April 7, 2025

Exenatide synthetic - Generic Drug Details


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What are the generic sources for exenatide synthetic and what is the scope of patent protection?

Exenatide synthetic is the generic ingredient in five branded drugs marketed by Astrazeneca Ab and Amneal, and is included in four NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Exenatide synthetic has four hundred and five patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Recent Clinical Trials for exenatide synthetic

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

SponsorPhase
Center for Neurology, StockholmPhase 2
Karolinska InstitutetPhase 2
Monash UniversityPhase 2

See all exenatide synthetic clinical trials

Pharmacology for exenatide synthetic
Paragraph IV (Patent) Challenges for EXENATIDE SYNTHETIC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BYETTA Injection exenatide synthetic 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe 021773 1 2014-06-11

US Patents and Regulatory Information for exenatide synthetic

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Amneal EXENATIDE SYNTHETIC exenatide synthetic INJECTABLE;SUBCUTANEOUS 206697-002 Nov 19, 2024 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for exenatide synthetic

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Try for Free ⤷  Try for Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

International Patents for exenatide synthetic

CountryPatent NumberTitleEstimated Expiration
Brazil PI0713544 solvatos cristalinos complexos de derivados de (1s)-1,5-anidro-1-c-(3-((fenil) metil)fenil)-d-glucitol com aminoÁcidos como inibidores de sglt2 para o tratamento de diabetes ⤷  Try for Free
Cyprus 1120644 ⤷  Try for Free
Denmark 2069374 ⤷  Try for Free
Japan 5128658 ⤷  Try for Free
Russian Federation 2489151 ФАРМАЦЕВТИЧЕСКАЯ КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР SGLT2 (PHARMACEUTICAL COMBINATION CONTAINING SGLT2 INHIBITOR) ⤷  Try for Free
Taiwan I254714 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for exenatide synthetic

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1506211 2014C/041 Belgium ⤷  Try for Free PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121
1506211 588 Finland ⤷  Try for Free
1506211 C01506211/02 Switzerland ⤷  Try for Free PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1734971 C300526 Netherlands ⤷  Try for Free PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1506211 CR 2014 00037 Denmark ⤷  Try for Free 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 PA2013008,C1506211 Lithuania ⤷  Try for Free PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for Exenatide Synthetic

Introduction to Exenatide Synthetic

Exenatide synthetic, commonly known by its brand name BYETTA, is a glucagon-like peptide-1 (GLP-1) receptor agonist used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The exenatide market has been growing at a rapid pace over the last few years and is expected to continue this trend through the forecast period of 2022 to 2030. This growth is driven by several key factors, including the increasing prevalence of diabetes, particularly in established and emerging countries, and the improved efficiency of GLP-1 agonists[1].

Key Drivers of Market Growth

Increasing Diabetes Prevalence

The rise in the diabetic population, attributed to factors such as increasing median age, obesity, and inactivity levels, is a significant driver. Countries with high percentages of geriatric populations, like Japan, Italy, Germany, and France, are expected to contribute substantially to this growth[1].

Technological Advancements and Healthcare Infrastructure

Advancements in healthcare technology and the availability of skilled medical professionals are also crucial. The increasing health awareness among consumers and the ease of access to medical knowledge via the internet further boost the market[1].

Geographical Contributions

The global exenatide market is segmented geographically, with North America expected to contribute the most due to its high per capita income. However, the Asia Pacific region, particularly China and India, has the highest number of diabetic patients, making it a significant market as well[1].

Market Segmentation

By Type

The market is segmented into extended-release injectable suspension and fast-release injectable suspension. The fast-release injectable suspension is more popular due to its lesser side effects and its ability to help patients lower their body weight, which is crucial for treating obese type 2 diabetes mellitus patients[1].

By Application

The market is segmented into hospital and drug store applications, with the drug store segment contributing more significantly. This is because exenatide is consumer-friendly and easy to use, requiring administration twice a day or once a week[1].

Competitive Landscape

The competitive landscape of the exenatide market includes major players such as Novo Nordisk, Sanofi, Eli Lilly, AstraZeneca, Teva Pharmaceuticals Industries, Bachem AG, and Ranbaxy Laboratories Limited. These companies are engaged in various development strategies to maintain and expand their market share[1].

Financial Trajectory

Revenue Projections

While exenatide is part of the older generation of GLP-1 agonists, its market share is expected to decline as newer, more effective drugs like Mounjaro and Ozempic gain traction. However, the overall GLP-1 agonist market is projected to grow significantly. For instance, Visible Alpha consensus revenue estimates for 2030 show substantial revenues for newer GLP-1 agonists, with Mounjaro leading at $20.6 billion and Ozempic at $18.1 billion[3].

Generic Market Entry

The recent FDA approval of Amneal’s generic exenatide injectable marks a significant milestone. This is one of the first generic GLP-1 injectables approved in the U.S., reflecting Amneal’s innovation and regulatory capabilities in complex pharmaceuticals. The entry of generics is expected to impact the pricing and market dynamics, potentially increasing accessibility and reducing costs for patients[5].

Challenges and Restraints

Despite the growth potential, the exenatide market faces several challenges. These include the rise in treatment costs, side effects such as low blood sugar, nausea, dizziness, and more serious conditions like medullary thyroid cancer and pancreatitis. Additionally, the increasing competition from newer, more effective GLP-1 agonists could reduce the market share of exenatide[1].

Impact of Newer GLP-1 Agonists

Newer GLP-1 agonists like Mounjaro and Ozempic have significantly improved drug profiles, offering better efficacy, safety, and dosing frequency. These drugs are also associated with cardiovascular benefits and more meaningful weight loss, which is likely to shift market preference away from older drugs like exenatide[3].

Off-Label Use and Supply Issues

The high demand for newer GLP-1 agonists, such as Wegovy and Ozempic, for weight loss has led to supply issues. This has resulted in off-label use of these drugs, further complicating the market dynamics for traditional GLP-1 agonists like exenatide[3].

Key Takeaways

  • The exenatide market is growing due to increasing diabetes prevalence and technological advancements.
  • The market is segmented by type and application, with fast-release injectable suspension and drug store segments being more prominent.
  • Major players are engaged in competitive strategies to maintain market share.
  • The entry of generic exenatide is expected to impact pricing and accessibility.
  • Newer GLP-1 agonists pose a significant challenge to the market share of exenatide.
  • Off-label use and supply issues of newer drugs affect the traditional GLP-1 agonist market.

FAQs

1. What is exenatide synthetic used for?

Exenatide synthetic, known by its brand name BYETTA, is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[5].

2. What are the key drivers of the exenatide market growth?

Key drivers include the increasing prevalence of diabetes, technological advancements, and the availability of skilled medical professionals. Geographical factors, such as high per capita income in North America and a large diabetic population in the Asia Pacific, also play a role[1].

3. How is the exenatide market segmented?

The market is segmented by type (extended-release and fast-release injectable suspensions) and application (hospital and drug store)[1].

4. What are the challenges faced by the exenatide market?

Challenges include the rise in treatment costs, side effects, and increasing competition from newer, more effective GLP-1 agonists[1].

5. How does the entry of generic exenatide impact the market?

The entry of generic exenatide is expected to increase accessibility and reduce costs for patients, potentially impacting the pricing and market dynamics of the drug[5].

Cited Sources:

  1. Verified Market Research: Exenatide Market Size, Trends, Scope, Opportunities, Share.
  2. Drug Patent Watch: Byetta.
  3. Visible Alpha: Analysts Forecast Revenues for Drugs Treating Type 2 Diabetes.
  4. ACS Publications: Synthesis, Optimization, and Biological Evaluation of Corrinated GLP-1R Agonist.
  5. Amneal Pharmaceuticals: Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide.

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