EXENATIDE SYNTHETIC - Generic Drug Details
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What are the generic sources for exenatide synthetic and what is the scope of freedom to operate?
Exenatide synthetic
is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Exenatide synthetic has four hundred and thirty-nine patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for EXENATIDE SYNTHETIC
International Patents: | 439 |
US Patents: | 21 |
Tradenames: | 4 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 7 |
Patent Applications: | 6,452 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXENATIDE SYNTHETIC |
DailyMed Link: | EXENATIDE SYNTHETIC at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXENATIDE SYNTHETIC
Generic Entry Dates for EXENATIDE SYNTHETIC*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS |
Generic Entry Dates for EXENATIDE SYNTHETIC*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES Dosage:
INJECTABLE;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for EXENATIDE SYNTHETIC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Karolinska Institutet | Phase 2 |
Center for Neurology, Stockholm | Phase 2 |
National Health and Medical Research Council, Australia | Phase 2 |
Pharmacology for EXENATIDE SYNTHETIC
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for EXENATIDE SYNTHETIC
Paragraph IV (Patent) Challenges for EXENATIDE SYNTHETIC
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BYETTA | Injection | exenatide synthetic | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | 021773 | 1 | 2014-06-11 |
US Patents and Regulatory Information for EXENATIDE SYNTHETIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ 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 | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 EXENATIDE SYNTHETIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXENATIDE SYNTHETIC
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 574346 | CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES | ⤷ Sign Up |
Japan | 5980872 | ⤷ Sign Up | |
Israel | 214180 | סולבטים גבישיים וקומפלקסים של נגזרות של (s1) -1, 5 אנהידרו- 1 - c - ( 3- ((פניל(מתיל(פניל)-d- גלוציטול עם חומצות אמינו המשמשים כמעכבי sglt2 עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes) | ⤷ Sign Up |
Hungary | E064811 | ⤷ Sign Up | |
Taiwan | 201546054 | Crystal structures of SGLT2 inhibitors and processes for preparing same | ⤷ Sign Up |
China | 104248623 | Sustained release formulations using non-aqueous carriers | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXENATIDE SYNTHETIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | PA2014026,C1506211 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1506211 | 122014000071 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1506211 | C01506211/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014 |
2139494 | C20200028 00358 | Estonia | ⤷ Sign Up | PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016 |
1734971 | 91989 | Luxembourg | ⤷ Sign Up | 91989, EXPIRES: 20260617 |
1734971 | C01734971/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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