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Generated: October 23, 2017

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Budesonide - Generic Drug Details

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What are the generic drug sources for budesonide and what is the scope of budesonide patent protection?

Budesonide
is the generic ingredient in nine branded drugs marketed by Amneal Pharms, Apotex Inc, Impax Labs Inc, Mylan, Valeant Pharms Intl, Teva Pharms, Mayne Pharma, Alvogen Malta, Perrigo Pharma Intl, Astrazeneca Pharms, Astrazeneca, Zydus Pharms Usa Inc, Sciecure Pharma Inc, Teva Pharms Usa, Sandoz Inc, Appco Pharma Llc, and Barr Labs Div Teva, and is included in twenty-three NDAs. There are thirty patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has one hundred and thirty-seven patent family members in thirty-nine countries and one supplementary protection certificate in one country.

There are twenty drug master file entries for budesonide. Thirty-eight suppliers are listed for this compound.

Summary for Generic Name: budesonide

US Patents:30
Tradenames:9
Applicants:17
NDAs:23
Drug Master File Entries: see list20
Suppliers / Packagers: see list38
Bulk Api Vendors: see list93
Clinical Trials: see list287
Patent Applications: see list8,309
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:budesonide at DailyMed

Pharmacology for Ingredient: budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-002Jun 24, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 2000ANRXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms Intl
UCERIS
budesonide
TABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms Intl
UCERIS
budesonide
AEROSOL, FOAM;RECTAL205613-001Oct 7, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► Subscribe► Subscribe
Apotex Inc
BUDESONIDE
budesonide
SUSPENSION;INHALATION078202-002Mar 30, 2009ANRXNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-003Jun 24, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-003Jun 24, 1997► Subscribe► Subscribe
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-002Jun 24, 1997► Subscribe► Subscribe
Valeant Pharms Intl
UCERIS
budesonide
AEROSOL, FOAM;RECTAL205613-001Oct 7, 2014► Subscribe► Subscribe
Astrazeneca
PULMICORT FLEXHALER
budesonide
POWDER, METERED;INHALATION021949-002Jul 12, 2006► Subscribe► Subscribe
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-003Jun 24, 1997► Subscribe► Subscribe
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-002Jun 24, 1997► Subscribe► Subscribe
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-003Jun 24, 1997► Subscribe► Subscribe
Astrazeneca
PULMICORT
budesonide
POWDER, METERED;INHALATION020441-002Jun 24, 1997► Subscribe► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 2000► Subscribe► Subscribe
Perrigo Pharma Intl
ENTOCORT EC
budesonide
CAPSULE;ORAL021324-001Oct 2, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: budesonide

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
7,410,652Controlled release and taste masking oral pharmaceutical composition► Subscribe
9,592,203Controlled release and taste masking oral pharmaceutical composition► Subscribe
8,029,823Controlled release and taste masking oral pharmaceutical composition► Subscribe
6,030,604 Formulation for inhalation► Subscribe
9,737,489Controlled release and taste masking oral pharmaceutical composition► 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 Ingredient: budesonide

Country Document Number Estimated Expiration
Japan2003501457► Subscribe
Japan2001509811► Subscribe
France2759908► Subscribe
Austria251449► Subscribe
Greece980100021► Subscribe
Australia6430598► Subscribe
Australia726916► Subscribe
Brazil9807996► Subscribe
Czech Republic9902557► Subscribe
Japan4790950► 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: BUDESONIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033United Kingdom► SubscribePRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
Citi
Mallinckrodt
Baxter
AstraZeneca
Healthtrust
Harvard Business School
Fuji
Chinese Patent Office
US Army

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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