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Generated: September 20, 2017
What is the patent landscape for Byetta, and what generic Byetta alternatives are available?
Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.| Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 12 |
| Clinical Trials: see list | 112 |
| Patent Applications: see list | 6 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | BYETTA at DailyMed |
| Ingredient-type | Glucagon-Like Peptide 1 |
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| exenatide | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | Byetta | 6/11/2014 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,026,210 | Exendins and exendin agonist analogs to regulate gastrointestinal motility | ► Subscribe | |||||||||||||||||||||||||||
| 8,263,550 | Exendin agonist compounds | ► Subscribe | |||||||||||||||||||||||||||
| 7,407,932 | Methods for glucagon suppression using modified exendins | ► Subscribe | |||||||||||||||||||||||||||
| 6,989,366 | Exendins, exendin agonists, and methods for their use | ► Subscribe | |||||||||||||||||||||||||||
| 7,220,721 | Exendin agonist peptides | ► Subscribe | |||||||||||||||||||||||||||
| 7,157,555 | Exendin agonist compounds | ► Subscribe | |||||||||||||||||||||||||||
| 8,288,338 | Exendin and exendin agonists for eating disorders | ► Subscribe | |||||||||||||||||||||||||||
| 7,138,375 | Use of exendins and agonists thereof for lowering plasma lipid | ► Subscribe | |||||||||||||||||||||||||||
| 7,399,489 | Exendin analog formulations | ► Subscribe | |||||||||||||||||||||||||||
| 7,858,740 | Exendin agonist compounds | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0041546 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 381939 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03099314 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2247676 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 275967 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 347901 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2343072 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2001501593 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2359031 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1347327 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/2007 | Austria | ► Subscribe | PRODUCT NAME: EXENATIDE | ||||||||||||||||||||||||||
| 1734971/01 | Switzerland | ► Subscribe | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012 | ||||||||||||||||||||||||||
| 4 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 2007 00033 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 342 | Luxembourg | ► Subscribe | 91342, EXPIRES: 20211120 | ||||||||||||||||||||||||||
| 90031-9 | Sweden | ► Subscribe | PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120 | ||||||||||||||||||||||||||
| 0996459/01 | Switzerland | ► Subscribe | FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US | ||||||||||||||||||||||||||
| 343 | Luxembourg | ► Subscribe | 91343, EXPIRES: 20211120 | ||||||||||||||||||||||||||
| 2012000028 | Germany | ► Subscribe | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 | ||||||||||||||||||||||||||
| 2007 00034 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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