PULMICORT Drug Patent Profile

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

Pulmicort is a drug marketed by Astrazeneca and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pulmicort

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

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Summary for PULMICORT

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	79
Patent Applications:	6,337
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PULMICORT
Drug Sales Revenues:	Drug sales revenues for PULMICORT
What excipients (inactive ingredients) are in PULMICORT?	PULMICORT excipients list
DailyMed Link:	PULMICORT at DailyMed

Drug patent expirations by year for PULMICORT

Recent Clinical Trials for PULMICORT

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Bond Avillion 2 Development LP	Phase 1
University of Oxford	Phase 2

See all PULMICORT clinical trials

US Patents and Regulatory Information for PULMICORT

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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	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-003	Aug 8, 2000	AN	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	AN	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for PULMICORT

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Falk Pharma GmbH	Jorveza	budesonide	EMEA/H/C/004655 Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).	Authorised	no	no	yes	2018-01-08
Stada Arzneimittel AG	Kinpeygo	budesonide	EMEA/H/C/005653 Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.	Authorised	no	no	yes	2022-07-15
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for PULMICORT

See the table below for patents covering PULMICORT around the world.

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Country	Patent Number	Title	Estimated Expiration
Yugoslavia	45115		⤷ Try a Trial
Portugal	84421	DISPOSITIVO EM INALADORES DE POS	⤷ Try a Trial
Sweden	448277	INDIKERINGSANORDNING VID EN DOSERINGSANORDNING FOR LEKEMEDEL	⤷ Try a Trial
Norway	164001		⤷ Try a Trial
Japan	H0147190		⤷ Try a Trial
Ireland	821495		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PULMICORT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2190014-7	Sweden	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024	LUC00208	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	2021C/518	Belgium	⤷ Try a Trial	PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
0613371	SPC/GB02/033	United Kingdom	⤷ Try a 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
2435024	132021000000095	Italy	⤷ Try a Trial	PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	21C1020	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description