DrugPatentWatch Database Preview
BYETTA Drug Profile
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. There are four patents protecting this drug and one Paragraph IV challenge.
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: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 114 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BYETTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BYETTA |
| DailyMed Link: | BYETTA at DailyMed |
Pharmacology for BYETTA
| Ingredient-type | Glucagon-Like Peptide 1 |
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Synonyms for BYETTA
| 141758-74-9 |
| 286014-72-0 |
| 335149-21-8 |
| 9P1872D4OL |
| AC 2993 |
| AC002993 |
| AC2993A |
| AKOS015994651 |
| Bydureon |
| Bydureon Pen |
| CS-1174 |
| DA 3091 |
| Exenatide |
| Exenatide [USAN:INN:BAN:JAN] |
| Exenatide; Exendin-4 |
| Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid- |
| Exendin 4 |
| Exendin-4 |
| HS-2012 |
| HSDB 7789 |
| HY-13443 |
| ITCA 650 |
| LY 2148568 |
| MolPort-009-194-177 |
| PT302 |
| SCHEMBL14634818 |
| UNII-9P1872D4OL |
| Y-100006 |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 | 021773-001 | 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 | ||||
| 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 |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for BYETTA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | ➤ Sign Up |
International Patents for BYETTA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Germany | 69739172 | ➤ Sign Up |
| Spain | 2278589 | ➤ Sign Up |
| Hong Kong | 1033465 | ➤ Sign Up |
| Netherlands | 300281 | ➤ Sign Up |
| Japan | 2003522721 | ➤ Sign Up |
| Australia | 2003239910 | ➤ Sign Up |
| Australia | 1458899 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for BYETTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2007 00033 | Denmark | ➤ Sign Up | PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120 |
| 0996459/01 | Switzerland | ➤ Sign Up | FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US |
| 00526 | Netherlands | ➤ Sign Up | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 30/2007 | Austria | ➤ Sign Up | PRODUCT NAME: EXENATIDE |
| 343 | Luxembourg | ➤ Sign Up | 91343, EXPIRES: 20211120 |
| 342 | Luxembourg | ➤ Sign Up | 91342, EXPIRES: 20211120 |
| 1734971/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
