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Serving leading biopharmaceutical companies globally:

Fuji
Citi
Deloitte
Daiichi Sankyo
UBS
Merck
Accenture
QuintilesIMS
Baxter
Cerilliant

Generated: January 19, 2018

DrugPatentWatch Database Preview

Budesonide - Generic Drug Details

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

Budesonide
is the generic ingredient in nine branded drugs marketed by Valeant Pharms Intl, Astrazeneca, Alvogen Malta, Amneal Pharms, Appco Pharma Llc, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms Usa Inc, Perrigo Pharma Intl, Apotex Inc, Astrazeneca Pharms, Cipla Ltd, Impax Labs Inc, Sandoz Inc, Teva Pharms, and Teva Pharms Usa, and is included in twenty-four NDAs. There are thirty patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has one hundred and forty-three patent family members in forty countries.

There are twenty-one drug master file entries for budesonide. Thirty-nine suppliers are listed for this compound.
Pharmacology for budesonide
Medical Subject Heading (MeSH) Categories for budesonide

US Patents and Regulatory Information for budesonide

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Teva Pharms BUDESONIDE budesonide SUSPENSION;INHALATION 077519-001 Nov 18, 2008 AN RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc BUDESONIDE budesonide SUSPENSION;INHALATION 078202-002 Mar 30, 2009 AN RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 AN RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amneal Pharms BUDESONIDE budesonide CAPSULE;ORAL 206200-001 Jul 31, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Valeant Pharms Intl UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-003 Jun 24, 1997 ➤ Subscribe ➤ Subscribe
Valeant Pharms Intl UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 ➤ Subscribe ➤ Subscribe
Perrigo Pharma Intl ENTOCORT EC budesonide CAPSULE;ORAL 021324-001 Oct 2, 2001 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for budesonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,592,203 Controlled release and taste masking oral pharmaceutical composition ➤ Subscribe
6,030,604 Formulation for inhalation ➤ Subscribe
9,737,489 Controlled release and taste masking oral pharmaceutical composition ➤ Subscribe
8,029,823 Controlled release and taste masking oral pharmaceutical composition ➤ Subscribe
7,410,652 Controlled release and taste masking oral pharmaceutical composition ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for budesonide

Supplementary Protection Certificates for budesonide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033 United Kingdom ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Accenture
Julphar
Healthtrust
Farmers Insurance
McKinsey
Covington
Cantor Fitzgerald
Daiichi Sankyo
AstraZeneca

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.

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