DrugPatentWatch Database Preview
BYETTA Drug Profile
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When do Byetta patents expire, and what generic alternatives are available?
This drug has one hundred and fifty-eight patent family members in twenty-one countries.
The generic ingredient in BYETTA is exenatide synthetic. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.
Summary for BYETTA
| International Patents: | 158 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 114 |
| Patent Applications: | 6 |
| Formulation / Manufacturing: | see details |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 Free Trial | ➤ Try a Free Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for BYETTA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
Non-Orange Book US Patents for BYETTA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,263,550 | Exendin agonist compounds | ➤ Try a Free Trial |
| 7,407,932 | Methods for glucagon suppression using modified exendins | ➤ Try a Free Trial |
| 7,153,825 | Methods for glucagon suppression using modified exendins | ➤ Try a Free Trial |
| 7,419,952 | Use of exendins and agonists thereof to treat diabetes | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for BYETTA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Austria | 493998 | ➤ Try a Free Trial |
| Denmark | 1246638 | ➤ Try a Free Trial |
| European Patent Office | 1032587 | ➤ Try a Free Trial |
| Hong Kong | 1025252 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for BYETTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 4 | Finland | ➤ Try a Free Trial | |
| 0996459/01 | Switzerland | ➤ Try a Free Trial | FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US |
| /2007 | Austria | ➤ Try a Free Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120 |
| 00526 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
