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Last Updated: May 20, 2022

AFINITOR DISPERZ Drug Patent Profile


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Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-nine patent family members in thirty-five countries.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the everolimus profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Afinitor Disperz

A generic version of AFINITOR DISPERZ was approved as everolimus by HIKMA on April 12th, 2018.

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Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AFINITOR DISPERZ Tablets for Oral Suspension everolimus 2 mg, 3 mg and 5 mg 203985 1 2016-12-30

US Patents and Regulatory Information for AFINITOR DISPERZ

AFINITOR DISPERZ is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting AFINITOR DISPERZ

FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 AFINITOR DISPERZ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AFINITOR DISPERZ

See the table below for patents covering AFINITOR DISPERZ around the world.

Country Patent Number Title Estimated Expiration
Portugal 2269603 See Plans and Pricing
Spain 2705016 See Plans and Pricing
Japan 5165199 See Plans and Pricing
Hungary 224074 O-alkilezett rapamicinszármazékok, azokat tartalmazó gyógyszerkészítmények és eljárás a gyógyszerkészítmények előállítására (O-ALKYLATED RAPAMYCIN DERIVATIVES PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND PROCESS FOR PRODUCING THE PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
Portugal 1137439 See Plans and Pricing
Norway 20150831 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663916 SPC/GB10/003 United Kingdom See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803
3351246 CA 2019 00056 Denmark See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3342411 122020000008 Germany See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20110824
3351246 PA2019521 Lithuania See Plans and Pricing PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269603 300769 Netherlands See Plans and Pricing PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725
2269604 CA 2016 00060 Denmark See Plans and Pricing PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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