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Budesonide - Generic Drug Details
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What are the generic sources for budesonide and what is the scope of patent protection?
Budesonide
is the generic ingredient in eleven branded drugs marketed by Salix, Astrazeneca, Sun Pharma Global, Alvogen, Amneal Pharms, Barr Labs Div Teva, Mayne Pharma, Mylan, Rising, Sciecure Pharma Inc, Zydus Pharms, Perrigo Pharma Intl, Apotex Inc, Astrazeneca Pharms, Cipla, Impax Labs Inc, Lupin, Nephron, Sandoz Inc, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Astrazeneca Ab, and is included in twenty-nine NDAs. There are thirty-four patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Budesonide has twenty-nine patent family members in seventeen countries.
There are twenty-two drug master file entries for budesonide. Thirty-nine suppliers are listed for this compound.
Summary for budesonide
| International Patents: | 29 |
| US Patents: | 34 |
| Tradenames: | 11 |
| Applicants: | 23 |
| NDAs: | 29 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 39 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 357 |
| Patent Applications: | 6,997 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for budesonide |
| Drug Sales Revenues: | Drug sales revenues for budesonide |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for budesonide |
| DailyMed Link: | budesonide at DailyMed |
Recent Clinical Trials for budesonide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 2 |
| ShiYue Li | N/A |
| NICHD Neonatal Research Network | Phase 3 |
Pharmacology for budesonide
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for budesonide
Paragraph IV (Patent) Challenges for BUDESONIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| UCERIS | TABLET, EXTENDED RELEASE;ORAL | budesonide | 203634 | 2013-03-11 |
| PULMICORT RESPULES | SUSPENSION;INHALATION | budesonide | 020929 | 2010-05-28 |
| ENTOCORT EC | CAPSULE;ORAL | budesonide | 021324 | 2008-02-01 |
| RHINOCORT ALLERGY | SPRAY, METERED;NASAL | budesonide | 020746 | 2007-05-14 |
| PULMICORT RESPULES | SUSPENSION;INHALATION | budesonide | 020929 | 2005-09-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | AB | 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 | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Pharms | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 077519-002 | Nov 18, 2008 | AN | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Labs Fl Inc | BUDESONIDE | budesonide | TABLET, EXTENDED RELEASE;ORAL | 205457-001 | Jul 3, 2018 | AB | RX | No | No | Start Trial | Start Trial | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | Start Trial | Start Trial |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | Start Trial | Start Trial |
| Astrazeneca Pharms | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | Start Trial | Start Trial |
| Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | Start Trial | Start Trial |
| Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for budesonide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20016108 | Start Trial |
| Denmark | 1183014 | Start Trial |
| Germany | 60005819 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0076478 | Start Trial |
| Turkey | 200200562 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for budesonide
| 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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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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.
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