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Exenatide - Generic Drug Details
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What are the generic drug sources for exenatide and what is the scope of patent protection?
Exenatide
is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are thirty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Exenatide has four hundred and eighty-eight patent family members in forty-seven countries.
There are seven drug master file entries for exenatide. One supplier is listed for this compound.
Summary for exenatide
International Patents: | 488 |
US Patents: | 36 |
Tradenames: | 4 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 7 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 17 |
Clinical Trials: | 272 |
Patent Applications: | 7 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for exenatide |
DailyMed Link: | exenatide at DailyMed |
Recent Clinical Trials for exenatide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dasman Diabetes Institute | Phase 4 |
University of Colorado, Denver | Phase 2/Phase 3 |
Central Hospital, Nancy, France | Phase 4 |
Recent Litigation for exenatide
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd. | 2019-07-17 |
AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc. | 2018-05-01 |
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED | 2018-01-09 |
PTAB Litigation
Petitioner | Date |
---|---|
Luye Pharma Group Ltd. | 2016-05-31 |
Pharmacology for exenatide
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Synonyms for exenatide
141732-76-5 |
141758-74-9 |
286014-72-0 |
335149-21-8 |
9P1872D4OL |
AC 2993 |
AKOS015994651 |
AKOS034831545 |
Bydureon |
Bydureon Pen |
CHEBI:64073 |
DA 3091 |
exenatida |
Exenatide [USAN:INN:BAN:JAN] |
Exenatide; Exendin-4 |
exenatidum |
Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid- |
Exendin 4 |
Exendin-4 |
H-His-Gly-Glu-Gly-xiThr-Phe-xiThr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-xiIle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 |
Heloderma suspectum gila monster exendin-4 |
His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 |
HS-2012 |
HSDB 7789 |
ITCA 650 |
LY 2148568 |
MolPort-009-194-177 |
PT302 |
SCHEMBL14634818 |
SCHEMBL20509814 |
UNII-9P1872D4OL |
Y-100006 |
US Patents and Regulatory Information for exenatide
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 | Y | Start Trial | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 exenatide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | Start Trial | Start Trial |
Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for exenatide
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 2013205769 | Start Trial |
Slovenia | 2069374 | Start Trial |
Denmark | 1246638 | Start Trial |
Portugal | 1971362 | Start Trial |
World Intellectual Property Organization (WIPO) | 03020245 | Start Trial |
European Patent Office | 2283820 | Start Trial |
European Patent Office | 1609478 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for exenatide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | 2013/013 | Ireland | Start Trial | PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112 |
1140145 | CA 2007 00033 | Denmark | Start Trial | PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120 |
1734971 | 2012C/017 | Belgium | Start Trial | PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617 |
1506211 | CR 2014 00037 | Denmark | Start Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
1506211 | PA2013008 | Lithuania | Start Trial | PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
1506211 | SPC/GB13/021 | United Kingdom | Start Trial | PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114 |
1734971 | CA 2012 00015 | Denmark | Start Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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