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PULMICORT RESPULES Drug Profile

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Which patents cover Pulmicort Respules, and what substitute generic drugs are available?

Pulmicort Respules is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one patent family member in one country.

The generic ingredient in PULMICORT RESPULES is budesonide. There are nineteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for Tradename: PULMICORT RESPULES

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list32
Clinical Trials: see list11
Patent Applications: see list11,534
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PULMICORT RESPULES at DailyMed

Pharmacology for Tradename: PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-001Aug 8, 2000RXYesNo6,598,603*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 2000RXYesYes6,598,603*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-002Aug 8, 2000RXYesNo6,598,603*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 2000RXYesYes6,899,099*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-001Aug 8, 2000RXYesNo6,899,099*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-001Aug 8, 20004,787,536*PED► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 20004,787,536*PED► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-002Aug 8, 20004,787,536*PED► Subscribe
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Paragraph IV activity for: PULMICORT RESPULES

Drugname Dosage Strength RLD Submissiondate
budesonideInhalation Suspension1 mg/2 mLPulmicort Respules5/28/2010
budesonideInhalation Suspension0.25 mg/2 mL and 0.5 mg/2 mLPulmicort Respules9/15/2005

International Patent Family for Tradename: PULMICORT RESPULES

Country Document Number Estimated Expiration
Canada2257329► 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: PULMICORT RESPULES

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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