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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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