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 fifteen branded drugs marketed by Padagis Israel, Salix, Astrazeneca, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Padagis Us, Sun Pharm Inds Inc, Calliditas, Apotex Inc, J And J Consumer Inc, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Takeda Pharms Usa, Actavis Labs Fl Inc, Mylan, and Astrazeneca Ab, and is included in thirty-six NDAs. There are thirty-five 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-one patent family members in thirty-one countries.
There are twenty-two drug master file entries for budesonide. Forty-two suppliers are listed for this compound.
Summary for budesonide
International Patents: | 141 |
US Patents: | 35 |
Tradenames: | 15 |
Applicants: | 29 |
NDAs: | 36 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 426 |
Patent Applications: | 6,741 |
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 |
What excipients (inactive ingredients) are in budesonide? | budesonide excipients list |
DailyMed Link: | budesonide at DailyMed |
Recent Clinical Trials for budesonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | Phase 3 |
Mansoura University | N/A |
Wolfson Medical Center | N/A |
Pharmacology for budesonide
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for budesonide
Anatomical Therapeutic Chemical (ATC) Classes for budesonide
Paragraph IV (Patent) Challenges for BUDESONIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
UCERIS | Extended-release Tablets | budesonide | 9 mg | 203634 | 1 | 2013-03-11 |
PULMICORT RESPULES | Inhalation Suspension | budesonide | 1 mg/2 mL | 020929 | 1 | 2010-05-28 |
ENTOCORT EC | Enteric Coated Capsules | budesonide | 3 mg | 021324 | 1 | 2008-02-01 |
RHINOCORT ALLERGY | Nasal Spray | budesonide | 0.032 mg (32 mcg)/spray | 020746 | 1 | 2007-05-14 |
PULMICORT RESPULES | Inhalation Suspension | budesonide | 0.25 mg/2 mL and 0.5 mg/2 mL | 020929 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 210897-001 | Nov 9, 2018 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Takeda Pharms Usa | EOHILIA | budesonide | SUSPENSION;ORAL | 213976-001 | Feb 9, 2024 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 201966-003 | Sep 27, 2013 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Cipla | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 205710-001 | Nov 16, 2017 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 budesonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ 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 RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for budesonide
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 budesonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5608641 | ⤷ Try a Trial | |
Japan | 2003501457 | ⤷ Try a Trial | |
European Patent Office | 2214679 | COMPOSITIONS CORTICOSTÉROÏDIENNES (CORTICOSTEROID COMPOSITIONS) | ⤷ Try a Trial |
Croatia | P20180408 | ⤷ Try a Trial | |
Slovenia | 2328553 | ⤷ Try a Trial | |
European Patent Office | 2230905 | PROCÉDÉ D'OBTENTION DE PERLES D'UN MATÉRIAU TRAITÉ INSECTICIDE ET CONSTITUÉ D'UN POLYSTYRÈNE EXPANSÉ, ET ÉLÉMENTS MOULÉS TRAITÉS INSECTICIDE AINSI OBTENUS (PROCESS FOR THE PRODUCTION OF INSECTICIDE-MODIFIED BEAD MATERIAL COMPOSED OF EXPANDABLE POLYSTYRENE AND INSECTICIDE-MODIFIED MOLDINGS OBTAINABLE THEREFROM) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for budesonide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | SPC/GB21/029 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
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 |
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 | 301102 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
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 | 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 |
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