DrugPatentWatch Database Preview
BYETTA Drug Profile
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See Plans and PricingWhen do Byetta patents expire, and what generic alternatives are available?
Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-four patent family members in nineteen countries.
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.
US ANDA Litigation and Generic Entry Outlook for Byetta
Byetta was eligible for patent challenges on April 28, 2009.
Annual sales in 2017 were $217mm indicating the motivation for generic entry (peak sales were $1.1bn in 2008).
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for BYETTA
| International Patents: | 74 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 117 |
| Patent Applications: | 6 |
| 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 |
| 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 |
| Boston Medical Center | Phase 1 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 1 |
Recent Litigation for BYETTA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| AstraZeneca Pharmaceuticals LP v. Amneal Pharmaceuticals LLC | 2015-12-09 |
| Sanofi-Aventis US LLC v. AstraZeneca Pharmaceuticals LP | 2015-07-31 |
| Teva Pharmaceuticals USA Inc. v. AstraZeneca Pharmaceuticals LP | 2015-01-19 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Sanofi-Aventis U.S. LLC | 2015-12-16 |
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 | NDA | Submissiondate |
|---|---|---|---|---|
| BYETTA | INJECTABLE;SUBCUTANEOUS | exenatide synthetic | 021773 | 2014-06-11 |
US Patents and Regulatory Information for BYETTA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | Start Trial | Start Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | Start Trial | Start Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | Start Trial | Start Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BYETTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 784488 | Start Trial |
| China | 100356978 | Start Trial |
| China | 1384755 | Start Trial |
| Australia | 777564 | Start Trial |
| Spain | 2244416 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BYETTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1140145 | 30/2007 | Austria | Start Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120 |
| 1734971 | 300526 | Netherlands | Start Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 1734971 | 122012000028 | Germany | Start Trial | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 1140145 | SZ 30/2007 | Austria | Start Trial | PRODUCT NAME: EXENATIDE |
| 1734971 | C300526 | Netherlands | Start Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
