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Last Updated: October 1, 2022

Details for Patent: 8,895,033


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Which drugs does patent 8,895,033 protect, and when does it expire?

Patent 8,895,033 protects BYDUREON BCISE and is included in one NDA.

Protection for BYDUREON BCISE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-nine patent family members in twenty-one countries.

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;

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 synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing
Brazil PI0918904 See Plans and Pricing
Canada 2734525 See Plans and Pricing
China 102164597 See Plans and Pricing
China 104248623 See Plans and Pricing
Denmark 2341905 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
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AstraZeneca
Merck
Boehringer Ingelheim
Harvard Business School

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