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Last Updated: August 11, 2020

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Details for Patent: 8,895,033

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Summary for Patent: 8,895,033
Title:Sustained release formulations using non-aqueous carriers
Abstract: The disclosure provides one-component, injectable, sustained release formulations which comprise microspheres containing active pharmaceutical ingredients (e.g., exenatide), wherein the microspheres are suspended in a non-aqueous carrier. The non-aqueous carrier can be an oil, a fractionated oil, triglycerides, diglycerides, monoglycerides, propylene glycol fatty acid diesters, and the like. The formulations offer distinct advantages of long shelf life for the stability and potency of the formulation and sustained release of active pharmaceutical ingredients to reduce the frequency of medication dosing and to increase patient compliance.
Inventor(s): Houchin; Mary L. (Rockville, MD), Lee; Robin H. (San Diego, CA), Qi; Hong (San Diego, CA), Oehrtman; Greg (San Diego, CA), Jennings; Robert N. (San Diego, CA), Coleman; Scott H. (San Diego, CA)
Assignee: Amylin Pharmaceuticals, LLC (San Diego, CA) AstraZeneca Pharmaceuticals LP (Wilmington, DE)
Application Number:13/060,225
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Delivery; Device; Dosage form;

Recent additions to Drugs Protected by US Patent 8,895,033

These patents are from the daily update and have not yet been integrated into the regular database
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Product Substance Delist Req. Patent Expiration Usecode Patented / Exclusive Use
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE 209210 Oct 20, 2017 RX Yes   Start Trial Y   Start Trial U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE 209210 Oct 20, 2017 RX Yes   Start Trial Y   Start Trial U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE 209210 Oct 20, 2017 RX Yes   Start Trial Y   Start Trial U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE 209210 Oct 20, 2017 RX Yes   Start Trial Y   Start Trial U-2600 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE 209210 Oct 20, 2017 RX Yes   Start Trial Y   Start Trial U-2601 STIMULATING INSULIN RELEASE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE 209210 Oct 20, 2017 RX Yes   Start Trial Y   Start Trial U-2602 DELAYING GASTRIC EMPTYING IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Type >RLD >Patent No. >Product >Substance >Delist Req. >Patent Expiration >Usecode >Patented / Exclusive Use

Drugs Protected by US Patent 8,895,033

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y STIMULATING INSULIN RELEASE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y DELAYING GASTRIC EMPTYING IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,895,033

PCT Information
PCT FiledSeptember 04, 2009PCT Application Number:PCT/US2009/056058
PCT Publication Date:March 11, 2010PCT Publication Number: WO2010/028257

International Family Members for US Patent 8,895,033

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009289529   Start Trial
Brazil PI0918904   Start Trial
Canada 2734525   Start Trial
China 102164597   Start Trial
China 104248623   Start Trial
Eurasian Patent Organization 020299   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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