BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - Generic Drug Details

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

Budesonide; formoterol fumarate dihydrate is the generic ingredient in two branded drugs marketed by Mylan and Astrazeneca, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Budesonide; formoterol fumarate dihydrate has one hundred and sixty-two patent family members in thirty-nine countries.

Four suppliers are listed for this compound.

Summary for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

International Patents:	162
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
DailyMed Link:	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE at DailyMed

Recent Clinical Trials for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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

Sponsor	Phase
Cipla Ltd.	Phase 3
Actavis Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3

See all BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE clinical trials

Pharmacology for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBICORT	Metered Inhalation	budesonide; formoterol fumarate dihydrate	80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation	021929	1	2018-06-26

US Patents and Regulatory Information for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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Glossary

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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	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-001	Mar 15, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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

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

EU/EMA Drug Approvals for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/004882 Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)	Authorised	no	no	no	2020-04-03
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/003953 Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.	Withdrawn	no	no	no	2014-11-19
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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Country	Patent Number	Title	Estimated Expiration
Argentina	054295	DISPOSITIVO INHALADOR	⤷ Sign Up
Canada	2569923	DISPOSITIF D'INHALATION ET SON PROCEDE D'ASSEMBLAGE (AN INHALATION DEVICE AND A METHOD FOR ASSEMBLING SAID INHALATION DEVICE)	⤷ Sign Up
Poland	1768727		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	SPC/GB02/033	United Kingdom	⤷ Sign Up	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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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.