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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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

SYMBICORT Drug Profile

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When do Symbicort patents expire, and what generic alternatives are available?

Symbicort is a drug marketed by Astrazeneca and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and four patent family members in forty-four countries.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.

Drug patent expirations by year for SYMBICORT
Drug Prices for SYMBICORT

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Drug Sales Revenue Trends for SYMBICORT

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Generic Entry Opportunity Date for SYMBICORT
Generic Entry Date for SYMBICORT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SYMBICORT

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

SponsorPhase
Istituto di Biomedicina e Immunologia Molecolare Alberto MonroyPhase 4
ParexelPhase 4
Shanghai Biomabs Pharmaceutical Co., Ltd.Phase 3

See all SYMBICORT clinical trials

Recent Litigation for SYMBICORT

Identify potential future generic entrants

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

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PTAB Litigation
PetitionerDate
Complex Innovations, LLC2017-01-09

See all SYMBICORT litigation

US Patents and Regulatory Information for SYMBICORT

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   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 021929-002 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
>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 SYMBICORT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
Paragraph IV (Patent) Challenges for SYMBICORT
Drugname Dosage Strength RLD Date
➤ Subscribe Metered Inhalation 80 mcg/4.5 mcg per inhalation and160 mcg/4.5 mcg per inhalation ➤ Subscribe   Start Trial

Supplementary Protection Certificates for SYMBICORT

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
Medtronic
Merck
Harvard Business School
Mallinckrodt
Colorcon

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.