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.
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Summary for BYETTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 124 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information 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 |
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 |
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.
FDA Regulatory Exclusivity protecting BYETTA
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Japan | 2003522721 | ⤷ Sign Up | |
| European Patent Office | 1246638 | UTILISATION D'EXENDINES ET D'AGONISTES DE CES DERNIERES POUR TRAITER L'HYPERTRIGLYCERIDEMIE (USE OF EXENDINS AND AGONISTS THEREOF FOR THE TREATMENT OF HYPERTRIGLYCERIDEMIA) | ⤷ Sign Up |
| Japan | 2003519667 | ⤷ Sign Up | |
| Austria | 275967 | ⤷ Sign Up | |
| Portugal | 1140145 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9830231 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: EXENATIDE |
| 0996459 | 464 | Finland | ⤷ Sign Up | |
| 1140145 | 30/2007 | Austria | ⤷ Sign Up | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120 |
| 1734971 | 2012C/017 | Belgium | ⤷ Sign Up | PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617 |
| 0996459 | CA 2007 00034 | Denmark | ⤷ Sign Up | |
| 1734971 | 300526 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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