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Serving leading biopharmaceutical companies globally:

Healthtrust
Citi
US Department of Justice
Covington
Novartis
Farmers Insurance
Cantor Fitzgerald
QuintilesIMS
Daiichi Sankyo
US Army

Generated: December 16, 2017

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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 Astrazeneca Pharms and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and two patent family members in thirty-nine countries and four supplementary protection certificates in three countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: ALVESCO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: ALVESCO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,290,539 Device for delivering an aerosol► Subscribe
6,030,682 Container for aerosol formulation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ALVESCO

Country Document Number Estimated Expiration
Germany4129535► Subscribe
China1257421► Subscribe
Switzerland683343► Subscribe
Canada2050812► Subscribe
Germany69128157► Subscribe
United Kingdom9118967► Subscribe
Slovakia157699► Subscribe
Israel132738► Subscribe
Japan2015024999► Subscribe
JapanH04257599► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ALVESCO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005006Lithuania► SubscribePRODUCT 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
2005006,C0983058Lithuania► SubscribePRODUCT 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
2005 00036Denmark► Subscribe
C022/2005Ireland► SubscribeSPC022/2005, 20060612, EXPIRES: 20190415
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Dow
Accenture
McKesson
Boehringer Ingelheim
Argus Health
Julphar
Covington
Baxter
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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