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 Astrazeneca 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-two 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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Questions you can ask:
- What is the 5 year forecast for PULMICORT FLEXHALER?
- What are the global sales for PULMICORT FLEXHALER?
- What is Average Wholesale Price for PULMICORT FLEXHALER?
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 |
Formulation / Manufacturing: | see details |
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 |
![PULMICORT FLEXHALER drug patent expirations Drug patent expirations by year for PULMICORT FLEXHALER](/p/graph/s/t/PULMICORT_FLEXHALER-patent-expirations.png)
![Drug Prices for PULMICORT FLEXHALER](/p/graph/drug-price/PULMICORT+FLEXHALER.png)
See drug prices for PULMICORT FLEXHALER
![Drug Sales Revenue Trends for PULMICORT FLEXHALER](/p/graph/drug-sales-revenues/PULMICORT+FLEXHALER.png)
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | 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 |
---|---|---|---|---|---|---|---|
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | 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 |
---|---|---|---|
Canada | 2277913 | NOUVELLE FORMULATION POUR INHALATION AYANT UNE MASSE VOLUMIQUE APPARENTE DE 0,28 A 0,38 G/ML, PROCEDE DE PREPARATION ET UTILISATION DE CETTE FORMULATION (NEW FORMULATION FOR INHALATION HAVING A POURED BULK DENSITY OF 0.28 TO 0.38 G/ML, A PROCESS FOR PREPARING THE FORMULATION AND THE USE THEREOF) | ⤷ Sign Up |
Yugoslavia | 34187 | ⤷ Sign Up | |
Australia | 601400 | ⤷ Sign Up | |
Japan | 4512204 | ⤷ 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 | 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 | 2190014-7 | Sweden | ⤷ Sign Up | 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 | 132021000000095 | Italy | ⤷ Sign Up | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |