➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Harvard Business School
Merck
AstraZeneca
Mallinckrodt

Last Updated: January 20, 2021

DrugPatentWatch Database Preview

PULMICORT RESPULES Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Which patents cover Pulmicort Respules, and when can generic versions of Pulmicort Respules launch?

Pulmicort Respules is a drug marketed by Astrazeneca Pharms and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Pulmicort Respules

A generic version of PULMICORT RESPULES was approved as budesonide by TEVA PHARMS on November 18th, 2008.

  Start Trial

Drug patent expirations by year for PULMICORT RESPULES
Drug Prices for PULMICORT RESPULES

See drug prices for PULMICORT RESPULES

Recent Clinical Trials for PULMICORT RESPULES

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

SponsorPhase
Xiuyi ZhiPhase 4
University of North Carolina, Chapel HillPhase 2
AstraZenecaPhase 4

See all PULMICORT RESPULES clinical trials

Pharmacology for PULMICORT RESPULES
Paragraph IV (Patent) Challenges for PULMICORT RESPULES
Tradename Dosage Ingredient NDA Submissiondate
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2010-05-28
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2005-09-15

US Patents and Regulatory Information for PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000 AN RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 AN RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 AN 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 PULMICORT RESPULES

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000   Start Trial   Start Trial
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-001 Aug 8, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PULMICORT RESPULES

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom   Start Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Johnson and Johnson
Dow
McKinsey
Moodys

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 verification 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.