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Last Updated: November 26, 2020

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ALVESCO Drug Profile

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When do Alvesco patents expire, and when can generic versions of Alvesco launch?

Alvesco is a drug marketed by Covis Pharma Bv and is included in one NDA. There is one patent protecting this drug.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in ALVESCO is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.

US ANDA Litigation and Generic Entry Outlook for Alvesco

Alvesco was eligible for patent challenges on October 20, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for ALVESCO
Drug Prices for ALVESCO

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Generic Entry Opportunity Date for ALVESCO
Generic Entry Date for ALVESCO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, METERED;INHALATION

*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 ALVESCO

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

SponsorPhase
Covis Pharma S.à.r.l.Phase 3
Centrallasarettet VästeråsPhase 2
Ola Blennow, MD, PhDPhase 2

See all ALVESCO clinical trials

US Patents and Regulatory Information for ALVESCO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Covis Pharma Bv ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Covis Pharma Bv ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-003 Jan 10, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 ALVESCO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-003 Jan 10, 2008   Start Trial   Start Trial
Covis Pharma Bv ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008   Start Trial   Start Trial
Covis Pharma Bv ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ALVESCO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0983058 SPC022/2005 Ireland   Start Trial SPC022/2005, 20060612, EXPIRES: 20190415
0983058 PA2005006 Lithuania   Start Trial PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
0983058 PA2005006,C0983058 Lithuania   Start Trial PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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