BYDUREON Drug Patent Profile

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When do Bydureon patents expire, and what generic alternatives are available?

Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are nineteen patents protecting this drug.

This drug has three hundred and forty-six patent family members in forty-eight countries.

The generic ingredient in BYDUREON 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bydureon

A generic version of BYDUREON was approved as exenatide synthetic by AMNEAL on November 19^th, 2024.

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Summary for BYDUREON

International Patents:	346
US Patents:	10
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Drug Prices:	Drug price information for BYDUREON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYDUREON
What excipients (inactive ingredients) are in BYDUREON?	BYDUREON excipients list
DailyMed Link:	BYDUREON at DailyMed

Drug patent expirations by year for BYDUREON

Recent Clinical Trials for BYDUREON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3
Dasman Diabetes Institute	Phase 4

See all BYDUREON clinical trials

US Patents and Regulatory Information for BYDUREON

BYDUREON is protected by ten US patents and two FDA Regulatory Exclusivities.

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Glossary

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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	⤷ Try for Free	⤷ Try for Free			Y	⤷ Try for Free
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try for Free	⤷ Try for Free			Y	⤷ Try for Free
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try for Free	⤷ Try for Free				⤷ Try for Free
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try for Free	⤷ Try for Free			Y	⤷ Try for Free
>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 BYDUREON

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try for Free	⤷ Try for Free
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try for Free	⤷ Try for Free
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try for Free	⤷ Try for Free
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BYDUREON

When does loss-of-exclusivity occur for BYDUREON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1730
Patent: ESTRUCTURAS DE CRISTAL DE INHIBIDORES SGLT2 Y PROCESOS PARA PREPARAR LOS MISMOS
Estimated Expiration: ⤷ Try for Free

Australia

Patent: 07265246
Patent: 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
Estimated Expiration: ⤷ Try for Free

Brazil

Patent: 0713544
Patent: solvatos cristalinos complexos de derivados de (1s)-1,5-anidro-1-c-(3-((fenil) metil)fenil)-d-glucitol com aminoÁcidos como inibidores de sglt2 para o tratamento de diabetes
Estimated Expiration: ⤷ Try for Free

Patent: 2017015106
Patent: estrutura de cristal de formula 1b e composição farmacêutica
Estimated Expiration: ⤷ Try for Free

Patent: 2017021516
Patent: processo de preparação de uma estrutura de cristal de solvato de (s)-propileno glicol de fórmula ia
Estimated Expiration: ⤷ Try for Free

Canada

Patent: 53344
Patent: SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-L-C-{3-[(PHENYL)METHYL]PHENYL}-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INHIBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS ASSGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 24318
Patent: SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INH IBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (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)
Estimated Expiration: ⤷ Try for Free

Patent: 85797
Patent: SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INH IBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (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)
Estimated Expiration: ⤷ Try for Free

Chile

Patent: 07001915
Patent: Compuesto cristalino de 6-[4-cloro-3-(4-etoxibencil)fenil]tetrahidropiran-2,3,4,5,-tetraol; procedimiento de preparacion; composicion farmaceutica que comprende a dicho compuesto; y su uso para preparar un medicamento para tratar diabetes, dislipidemia, obesidad, entre otras.
Estimated Expiration: ⤷ Try for Free

China

Patent: 1479287
Patent: 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
Estimated Expiration: ⤷ Try for Free

Patent: 3145773
Patent: 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
Estimated Expiration: ⤷ Try for Free

Colombia

Patent: 60299
Patent: SOLVATOS CRISTALINOS Y COMPLEJOS DE DERIVADOS DE (1S)-1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOÁCIDOS COMO INHIBIDORES SGLT2 PARA EL TRATAMIENTO DE DIABETES.
Estimated Expiration: ⤷ Try for Free

Croatia

Patent: 0141007
Estimated Expiration: ⤷ Try for Free

Cyprus

Patent: 15738
Estimated Expiration: ⤷ Try for Free

Denmark

Patent: 69374
Estimated Expiration: ⤷ Try for Free

Eurasian Patent Organization

Patent: 8229
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА (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)
Estimated Expiration: ⤷ Try for Free

Patent: 0428
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-С-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА (CRYSTALLINE SOLVATES OF (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 8259
Patent: КРИСТАЛЛИЧЕСКИЙ СОЛЬВАТ ПРОИЗВОДНОГО (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТОЙ И СПОСОБ ЕГО ПОЛУЧЕНИЯ (CRYSTALLINE SOLVATE OF (1S)-1,5-ANHYDRO-L-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVE WITH AMINO ACID AND PROCESS FOR PREPARING THE SAME)
Estimated Expiration: ⤷ Try for Free

Patent: 5999
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА (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)
Estimated Expiration: ⤷ Try for Free

Patent: 0900066
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ) -D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Try for Free

Patent: 1171333
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-С-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Try for Free

Patent: 1490902
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Try for Free

Patent: 1791254
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Try for Free

Patent: 2091391
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА
Estimated Expiration: ⤷ Try for Free

European Patent Office

Patent: 69374
Patent: SOLVATES CRISTALLINS DE DÉRIVÉS DE (1S)-1,5-ANHYDRO-1-C-(3-((PHÉNYL)MÉTHYL)PHÉNYL)-D-GLUCITOL AVEC DES ALCOHOLS EN TANT QU'INHIBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABÈTE (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 57918
Patent: Solvates cristallins et complexes de dérivés de (1S)-1,5-anhydro-1-C-((phényl)méthyl) phényl)-d-glucitol avec acides aminés en tant qu'inhibiteurs SGLT2 pour le traitement des diabètes (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)
Estimated Expiration: ⤷ Try for Free

Patent: 45466
Patent: SOLVATE DE PROPYLENE GLYCOLE DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL EN TANT QU'INHIBITEURS DU SGLT2 POUR LE TRAITEMENT DU DIABÈTE ((2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL PROPYLENE GLYCOL SOLVATE AS SGT2 INHIBITOR FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 63807
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT SOLVATE DE (S)-PROPYLENE GLYCOL DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL CRISTALLINE (PHARMACEUTICAL COMPOSITION COMPRISING CRYSTALLINE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL (S)-PROPYLENE GLYCOL SOLVATE)
Estimated Expiration: ⤷ Try for Free

Hong Kong

Patent: 27359
Patent: 用於治療糖尿病的抑製劑的 -脫水- 苯基甲基苯基 -葡萄糖醇衍生物與醇的結晶溶劑合物 (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)- D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES SGLT2 (1S)-15--1-C-(3 -(()))-D-)
Estimated Expiration: ⤷ Try for Free

Israel

Patent: 5882
Patent: צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes)
Estimated Expiration: ⤷ Try for Free

Patent: 4180
Patent: 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)
Estimated Expiration: ⤷ Try for Free

Patent: 4181
Patent: סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt 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)
Estimated Expiration: ⤷ Try for Free

Patent: 4182
Patent: סולבטים גבישיים וקומפלקסים של נגזרות 1s))-5,1-אנהידרו-1-c-(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt 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)
Estimated Expiration: ⤷ Try for Free

Japan

Patent: 13889
Estimated Expiration: ⤷ Try for Free

Patent: 66651
Estimated Expiration: ⤷ Try for Free

Patent: 37187
Estimated Expiration: ⤷ Try for Free

Patent: 09545525
Estimated Expiration: ⤷ Try for Free

Patent: 13209394
Patent: 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 TREATMENT OF DIABETES
Estimated Expiration: ⤷ Try for Free

Patent: 15071636
Patent: 糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (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 TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 16172758
Patent: 糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 17222681
Patent: 糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (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 TREATMENT OF DIABETES)
Estimated Expiration: ⤷ Try for Free

Patent: 19059779
Patent: 糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES HAVING AMINO ACIDS AS SGLT2 INHIBITORS FOR TREATING DIABETES)
Estimated Expiration: ⤷ Try for Free

Malaysia

Patent: 8566
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5- ANHYDRO-1 -C-(3-( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
Estimated Expiration: ⤷ Try for Free

Patent: 3930
Patent: CRYSTALLINE SOLVATES AND COMPLEXES OF (IS)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
Estimated Expiration: ⤷ Try for Free

Mexico

Patent: 9143
Patent: SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S)-1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (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.)
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Patent: 7155
Patent: SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S)-1, 5-ANHIDRO-1-C- (3-((FENIL) METIL) FENIL) -D-GLUCITOL CON AMINOÁCIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (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.)
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Patent: 08015377
Patent: SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S) - 1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (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.)
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New Zealand

Patent: 4346
Patent: 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
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Patent: 9190
Patent: 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
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Patent: 9195
Patent: 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
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Patent: 9202
Patent: 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
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Norway

Patent: 6828
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Patent: 7770
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Patent: 085169
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Patent: 221233
Patent: Krystallinske solvater og komplekser av (1S)-1,5-anhydro-1-C-(3-((fenyl)metyl)fenyl)-D-glucitol-derivater med aminosyrer som SGLT2-inhibitorer for behandling av diabetes
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Peru

Patent: 080349
Patent: ESTRUCTURAS DE CRISTAL DE INHIBIDORES SGLT2 Y PROCESOS PARA PREPARAR LOS MISMOS
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Patent: 120776
Patent: ESTRUCTURAS CRISTALINAS DE DAPAGLIFLOZIN Y SUS PROCESOS DE PREPARACION
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Philippines

Patent: 012500168
Patent: 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
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Poland

Patent: 69374
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Portugal

Patent: 69374
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Serbia

Patent: 638
Patent: KRISTALNI SOLVATI DERIVATA (1S)-1,5-ANHIDRO-1-C-(3-((FENIL) METIL) FENIL)-D-GLUCITOLA SA ALKOHOLIMA KAO INHIBITORI SGLT2 ZA TRETMAN DIJABETESA (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)
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Singapore

Patent: 2741
Patent: 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
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Patent: 201402181S
Patent: 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
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Slovenia

Patent: 69374
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South Africa

Patent: 0810475
Patent: 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
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South Korea

Patent: 1493102
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Patent: 090023643
Patent: 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
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Spain

Patent: 21665
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Patent: 59862
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Patent: 69130
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Taiwan

Patent: 21245
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Patent: 66876
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Patent: 19528
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Patent: 0811127
Patent: Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent: 1406743
Patent: Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent: 1509927
Patent: Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent: 1546054
Patent: Crystal structures of SGLT2 inhibitors and processes for preparing same
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Ukraine

Patent: 765
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (IS)-1,5-АНГИДРО-L-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ КАК ИНГИБИТОРЫ БЕЛКА SGLT2, ПРИГОДНЫЕ В ЛЕЧЕНИИ ДИАБЕТА;КРИСТАЛІЧНІ СОЛЬВАТИ І КОМПЛЕКСИ ПОХІДНИХ (IS)-1,5-АНГІДРО-L-C-(3-((ФЕНІЛ)МЕТИЛ)ФЕНІЛ)-D-ГЛЮЦИТОЛУ З АМІНОКИСЛОТАМИ ЯК ІНГІБІТОРИ БІЛКА SGLT2, ПРИДАТНІ У ЛІКУВАННІ ДІАБЕТУ (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)
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYDUREON around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1629849	Compositions pharmaceutiques contenant des exendines et leurs agonistes (Pharmaceutical compositions comprising exendins and agonists thereof)	⤷ Try for Free
World Intellectual Property Organization (WIPO)	2009143640		⤷ Try for Free
Eurasian Patent Organization	201490902	КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА	⤷ Try for Free
Colombia	5251414	INHIBIDORES DE SGLT2 DE GLUCOSIDOS DE C-ARILO Y METODO	⤷ Try for Free
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BYDUREON

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140145	91343	Luxembourg	⤷ Try for Free	91343, EXPIRES: 20211120
1734971	122012000028	Germany	⤷ Try for Free	PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1506211	C20130006 00074	Estonia	⤷ Try for Free	PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211	SPC/GB14/050	United Kingdom	⤷ Try for Free	PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Market Dynamics and Financial Trajectory for Bydureon

Introduction

Bydureon, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been a significant player in the treatment of type 2 diabetes since its introduction by AstraZeneca. Here, we delve into the market dynamics and financial trajectory of Bydureon, highlighting its evolution, challenges, and future prospects.

Historical Context and Evolution

Bydureon was first introduced in 2012 as a once-weekly therapy, building on the success of its predecessor, Byetta, which was the first GLP-1 receptor agonist to hit the market in 2005. Initially, Bydureon required users to mix ingredients and assemble the syringe, a process that was not user-friendly. However, AstraZeneca later improved the formulation by introducing a more convenient auto-injector device[4].

Market Performance and Sales

Bydureon's sales have faced significant challenges in recent years. Despite being a pioneer in the GLP-1 market, Bydureon has been squeezed by competitors such as Eli Lilly's Trulicity, Merck’s Januvia, and Novo Nordisk’s Victoza and Ozempic. This competition has led to a decline in sales for Bydureon and its predecessor, Byetta[4].

Clinical Trials and Regulatory Approvals

A recent significant development for Bydureon is its completion of a phase 3 trial in children and adolescents with type 2 diabetes. This trial, presented at the American Diabetes Association’s 81st Scientific Sessions, showed promising results, reducing A1C levels over 24 weeks. This could pave the way for FDA approval and provide a much-needed treatment option for an underserved patient population[4].

Market Dynamics

Competitive Landscape

The GLP-1 receptor agonist market is highly competitive, with several strong players. Bydureon faces intense competition from newer and more potent GLP-1 agonists. For instance, Novo Nordisk’s oral semaglutide is gaining traction, which could further challenge Bydureon’s market share[4].

Patient Population and Demand

There is an expanding younger patient population with type 2 diabetes, which presents an opportunity for Bydureon. The trial results in children and adolescents indicate that Bydureon can make a significant difference in this demographic, potentially increasing its market demand[4].

Geographical Expansion

While Bydureon has a global presence, its sales are impacted by regional market dynamics. For example, the implementation of the Value-Based Purchasing (VBP) program in China has affected the sales of various diabetes medications, including those from AstraZeneca[2].

Financial Trajectory

Revenue Trends

Bydureon's revenue has been declining due to the intense competition in the GLP-1 market. AstraZeneca's overall diabetes franchise, which includes Bydureon and Byetta, has seen sales drop as newer medications gain market share[4].

Cost and Pricing

The financial performance of Bydureon is also influenced by its pricing strategy. With generic competitors and newer, more effective medications entering the market, AstraZeneca may need to adjust pricing to remain competitive. However, this could impact the profitability of the drug[4].

Research and Development Investments

AstraZeneca continues to invest in research and development, including new formulations and indications for Bydureon. These investments are crucial for maintaining market relevance and potentially expanding the drug's use into new patient populations[2].

Future Prospects

Regulatory Approvals and New Indications

The potential FDA approval for Bydureon in children and adolescents with type 2 diabetes could revitalize the drug's market presence. New indications and approvals can help Bydureon regain some of its lost market share[4].

Product Innovations

Improvements in the delivery mechanism, such as the auto-injector device, have made Bydureon more user-friendly. Continued innovation in product formulation and delivery could enhance patient compliance and satisfaction, potentially boosting sales[4].

Strategic Partnerships

Collaborations with healthcare providers, research institutions, and other industry players can help AstraZeneca access new markets and patient populations. Strategic partnerships can also facilitate joint research efforts and knowledge exchange, which could lead to new opportunities for Bydureon[3].

Key Takeaways

Competitive Landscape: Bydureon faces significant competition from newer GLP-1 agonists.
Clinical Trials: Recent trials in children and adolescents with type 2 diabetes show promising results.
Market Dynamics: Expanding younger patient population and geographical expansion present opportunities.
Financial Trajectory: Revenue decline due to competition, with potential for revival through new approvals and innovations.
Future Prospects: Regulatory approvals, product innovations, and strategic partnerships are crucial for Bydureon’s future.

FAQs

What is Bydureon, and how does it differ from other GLP-1 agonists? Bydureon is a once-weekly GLP-1 receptor agonist used to treat type 2 diabetes. It differs from other GLP-1 agonists in its delivery mechanism, having evolved from a twice-daily to a once-weekly auto-injector form.
Why has Bydureon's sales been declining? Bydureon's sales have declined due to intense competition from newer and more potent GLP-1 agonists like Trulicity, Januvia, Victoza, and Ozempic.
What are the recent clinical trial results for Bydureon? Recent phase 3 trials have shown that Bydureon can effectively reduce A1C levels in children and adolescents with type 2 diabetes, potentially paving the way for FDA approval.
How does Bydureon's market performance compare globally? Bydureon's market performance varies globally, with regional factors such as the VBP program in China impacting sales. However, it maintains a global presence and is seeking to expand into new patient populations.
What are the future prospects for Bydureon? Future prospects include potential FDA approval for new indications, continued product innovations, and strategic partnerships to access new markets and patient populations.

Sources

AstraZeneca Full-year and Q4 2023 results announcement[1]
AstraZeneca Full year and Q4 2022 results[2]
Global Exenatide market 2024-2032[3]
ADA 2021: AstraZeneca touts Bydureon trial win in children and adolescents with type 2 diabetes[4]

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Summary for BYDUREON

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Introduction

Historical Context and Evolution

Market Performance and Sales

Clinical Trials and Regulatory Approvals

Market Dynamics

Competitive Landscape

Patient Population and Demand

Geographical Expansion

Financial Trajectory

Revenue Trends

Cost and Pricing

Research and Development Investments

Future Prospects

Regulatory Approvals and New Indications

Product Innovations

Strategic Partnerships

Key Takeaways

FAQs

Sources

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