BUDESONIDE Drug Patent Profile
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Which patents cover Budesonide, and what generic alternatives are available?
Budesonide is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex Inc, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Mylan. and is included in twenty-one NDAs.
The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Budesonide
A generic version of BUDESONIDE was approved as budesonide by TEVA PHARMS on November 18th, 2008.
Summary for BUDESONIDE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 34 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 426 |
| Patent Applications: | 6,138 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
See drug prices for BUDESONIDE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 204548-001 | Mar 8, 2016 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Actavis Labs Fl Inc | BUDESONIDE | budesonide | TABLET, EXTENDED RELEASE;ORAL | 205457-001 | Jul 3, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Padagis Israel | BUDESONIDE | budesonide | AEROSOL, FOAM;RECTAL | 215328-001 | Apr 12, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Nephron | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 078202-001 | Mar 30, 2009 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 211922-002 | Apr 14, 2021 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rising | BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 207367-001 | Apr 7, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Barr Labs Div Teva | BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 090379-001 | Apr 2, 2014 | DISCN | 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 |
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 |
