Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
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Moodys
Boehringer Ingelheim
Mallinckrodt
Harvard Business School

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Budesonide; formoterol fumarate dihydrate - Generic Drug Details

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What are the generic sources for budesonide; formoterol fumarate dihydrate and what is the scope of patent protection?

Budesonide; formoterol fumarate dihydrate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Budesonide; formoterol fumarate dihydrate has three hundred and four patent family members in forty-four countries.

There are twenty-two drug master file entries for budesonide; formoterol fumarate dihydrate. One supplier is listed for this compound.

Summary for budesonide; formoterol fumarate dihydrate
Recent Clinical Trials for budesonide; formoterol fumarate dihydrate

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SponsorPhase
3MPhase 3
Intech Biopharm Ltd.Phase 1
Actavis Inc.Phase 3

See all budesonide; formoterol fumarate dihydrate clinical trials

Recent Litigation for budesonide; formoterol fumarate dihydrate

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District Court Litigation
Case NameDate
AstraZeneca AB v. Mylan Pharmaceuticals Inc.

See all budesonide; formoterol fumarate dihydrate litigation

PTAB Litigation
PetitionerDate
Complex Innovations, LLC2017-01-09

See all budesonide; formoterol fumarate dihydrate litigation

Pharmacology for budesonide; formoterol fumarate dihydrate
Paragraph IV (Patent) Challenges for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Tradename Dosage Ingredient NDA Submissiondate
SYMBICORT AEROSOL, METERED;INHALATION budesonide; formoterol fumarate dihydrate 021929 2018-06-26

US Patents and Regulatory Information for budesonide; formoterol fumarate dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes   Start Trial   Start Trial Y   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 budesonide; formoterol fumarate dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Start Trial   Start Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for budesonide; formoterol fumarate dihydrate

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

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Merck
Medtronic
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Boehringer Ingelheim

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.