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Budesonide - Generic Drug Details

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

This ingredient has one hundred and thirty-six patent family members in thirty-eight countries.

There are nineteen drug master file entries for budesonide. Thirty-two suppliers are listed for this compound.

Summary for Generic Name: budesonide

Tradenames:9
Patents:30
Applicants:12
NDAs:18
Drug Master File Entries: see list19
Suppliers / Packaging: see list32
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-001Aug 8, 2000RXNo7,524,834*PED► subscribeY► subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYes7,367,333► subscribeY ► subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 2000RXYes7,524,834*PED► subscribeY► 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 Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-002Aug 8, 20004,787,536*PED► subscribe
Astrazeneca
PULMICORT FLEXHALER
budesonide
POWDER, METERED;INHALATION021949-001Jul 12, 20064,907,583► subscribe
Astrazeneca
PULMICORT FLEXHALER
budesonide
POWDER, METERED;INHALATION021949-002Jul 12, 20064,907,583► 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
8,029,823Controlled release and taste masking oral pharmaceutical composition► subscribe
6,030,604 Formulation for inhalation► subscribe
7,410,652Controlled 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
Australia5785798► subscribe
Turkey200200562► subscribe
World Intellectual Property Organization (WIPO)9831352► 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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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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