BYETTA Drug Patent Profile
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When do Byetta patents expire, and when can generic versions of Byetta launch?
Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA.
The generic ingredient in BYETTA 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.
Summary for BYETTA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 124 |
Patent Applications: | 8 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BYETTA |
Drug Sales Revenues: | Drug sales revenues for BYETTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BYETTA |
What excipients (inactive ingredients) are in BYETTA? | BYETTA excipients list |
DailyMed Link: | BYETTA at DailyMed |



DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BYETTA
Generic Entry Date for BYETTA*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES NDA:
Dosage:
INJECTABLE;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 BYETTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Consano Clinical Research, LLC | Phase 4 |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 1 |
Boston Medical Center | Phase 1 |
Pharmacology for BYETTA
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BYETTA
Paragraph IV (Patent) Challenges for BYETTA
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 BYETTA
BYETTA is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYETTA is ⤷ Try a Trial.
This potential generic entry date is based on INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting BYETTA
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 BYETTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BYETTA
See the table below for patents covering BYETTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69740096 | ⤷ Try a Trial | |
Spain | 2425559 | ⤷ Try a Trial | |
Australia | 2413600 | ⤷ Try a Trial | |
Germany | 60105547 | ⤷ Try a Trial | |
Denmark | 1143989 | ⤷ Try a Trial | |
New Zealand | 504258 | Exendin 3 and 4 agonist compounds for the treatment of diabetes | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYETTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0996459 | SZ 31/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE |
1140145 | CA 2007 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120 |
0996459 | C00996459/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US |
1734971 | 300526 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
1734971 | C300526 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
1140145 | 30/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |