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 fourteen 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, Actavis Labs Fl Inc, Mylan, and Astrazeneca Ab, and is included in thirty-five NDAs. There are twenty-two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Budesonide has forty patent family members in nineteen countries.
There are twenty-two drug master file entries for budesonide. Forty-two suppliers are listed for this compound.
Summary for budesonide
International Patents: | 40 |
US Patents: | 22 |
Tradenames: | 14 |
Applicants: | 28 |
NDAs: | 35 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | SYMBICORT AEROSPHERE | budesonide; formoterol fumarate | AEROSOL, METERED;INHALATION | 216579-001 | Apr 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Calliditas | TARPEYO | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 215935-001 | Dec 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | ||||
Zydus Pharms | BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206134-001 | May 4, 2017 | AB | RX | No | 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 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 | ⤷ 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 RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | 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 |
>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 |
---|---|---|---|
Hong Kong | 1046244 | Controlled release and taste masking oral pharmaceutical compositions. | ⤷ Try a Trial |
Japan | 2003501457 | ⤷ Try a Trial | |
Germany | 60005819 | ⤷ Try a Trial | |
Russian Federation | 2246293 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ С РЕГУЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ АКТИВНОГО ИНГРЕДИЕНТА И МАСКИРУЕМЫМ ВКУСОМ (PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION WITH SUSTAINED-RELEASING ACTIVE COMPONENT AND MASKING TASTE) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2009138716 | ⤷ 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 | 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 |
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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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