PULMICORT FLEXHALER Drug Patent Profile
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When do Pulmicort Flexhaler patents expire, and what generic alternatives are available?
Pulmicort Flexhaler is a drug marketed by Cheplapharm and is included in one NDA.
The generic ingredient in PULMICORT FLEXHALER 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 Pulmicort Flexhaler
A generic version of PULMICORT FLEXHALER was approved as budesonide by TEVA PHARMS on November 18th, 2008.
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Summary for PULMICORT FLEXHALER
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 6 |
| Patent Applications: | 6,337 |
| Drug Prices: | Drug price information for PULMICORT FLEXHALER |
| What excipients (inactive ingredients) are in PULMICORT FLEXHALER? | PULMICORT FLEXHALER excipients list |
| DailyMed Link: | PULMICORT FLEXHALER at DailyMed |
See drug prices for PULMICORT FLEXHALER
Recent Clinical Trials for PULMICORT FLEXHALER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 1 |
| Columbia University | Phase 4 |
| West Penn Allegheny Health System | Phase 4 |
Pharmacology for PULMICORT FLEXHALER
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for PULMICORT FLEXHALER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 PULMICORT FLEXHALER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for PULMICORT FLEXHALER
| 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 PULMICORT FLEXHALER
See the table below for patents covering PULMICORT FLEXHALER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 327426 | ⤷ Sign Up | |
| Denmark | 1007121 | ⤷ Sign Up | |
| New Zealand | 337551 | Inhalation device including an indicating wheel with a viewable side surface | ⤷ Sign Up |
| Denmark | 162424 | ⤷ Sign Up | |
| France | 2759908 | NOUVELLE COMPOSITION POUR INHALATION | ⤷ Sign Up |
| South Korea | 20000070188 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PULMICORT FLEXHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | 21C1020 | France | ⤷ Sign Up | 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 |
| 2435024 | SPC/GB21/029 | United Kingdom | ⤷ Sign Up | 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 | LUC00208 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| 2435024 | 301102 | Netherlands | ⤷ Sign Up | 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 | 2021C/518 | Belgium | ⤷ Sign Up | 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 |
| 0613371 | SPC/GB02/033 | United Kingdom | ⤷ Sign Up | 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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