PULMICORT RESPULES Drug Patent Profile
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Which patents cover Pulmicort Respules, and when can generic versions of Pulmicort Respules launch?
Pulmicort Respules is a drug marketed by Astrazeneca and is included in one NDA.
The generic ingredient in PULMICORT RESPULES 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 Respules
A generic version of PULMICORT RESPULES was approved as budesonide by TEVA PHARMS on November 18th, 2008.
Summary for PULMICORT RESPULES
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 13 |
Patent Applications: | 6,337 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PULMICORT RESPULES |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PULMICORT RESPULES |
What excipients (inactive ingredients) are in PULMICORT RESPULES? | PULMICORT RESPULES excipients list |
DailyMed Link: | PULMICORT RESPULES at DailyMed |
Recent Clinical Trials for PULMICORT RESPULES
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bond Avillion 2 Development LP | Phase 1 |
Xiuyi Zhi | Phase 4 |
Yale University | N/A |
Pharmacology for PULMICORT RESPULES
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PULMICORT RESPULES
Paragraph IV (Patent) Challenges for PULMICORT RESPULES
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PULMICORT RESPULES | Inhalation Suspension | budesonide | 1 mg/2 mL | 020929 | 1 | 2010-05-28 |
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 PULMICORT RESPULES
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | AN | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | AN | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | AN | RX | Yes | Yes | ⤷ 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 PULMICORT RESPULES
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | 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 PULMICORT RESPULES
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 RESPULES
See the table below for patents covering PULMICORT RESPULES around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I242436 | ⤷ Try a Trial | |
Israel | 136086 | PROCESS FOR PREPARATION OF STERILE GLUCOCORTICOSTEROIDS | ⤷ Try a Trial |
China | 1173702 | ⤷ Try a Trial | |
European Patent Office | 1032396 | STERILISATION DES GLUCOCORTICOSTEROIDES (STERILIZATION OF GLUCOCORTICOSTEROIDS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PULMICORT RESPULES
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |