Budesonide Patent Expiration
Budesonide is Used for long-term management of asthma in adults and children aged 6 and older, including those needing oral corticosteroids. It was first introduced by Astrazeneca Lp
Budesonide Patents
Given below is the list of patents protecting Budesonide, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Tarpeyo | US11896719 | Pharmaceutical compositions | Jan 23, 2043 | Calliditas |
| Tarpeyo | US12171882 | Pharmaceutical compositions | Jan 23, 2043 | Calliditas |
| Tarpeyo | US12171883 | Pharmaceutical compositions | Jan 23, 2043 | Calliditas |
| Tarpeyo | US12311057 | Pharmaceutical compositions | Jan 23, 2043 | Calliditas |
| Eohilia | US11260064 | Stable corticosteroid compositions | Jan 10, 2039 | Takeda Pharms Usa |
| Eohilia | US11564934 | Stable corticosteroid compositions | Jan 10, 2039 | Takeda Pharms Usa |
| Ortikos | US10172802 | Oral pharmaceutical dosage forms of budesonide | Sep 09, 2036 | Sun Pharm Inds Inc |
| Ortikos | US9707182 | Oral pharmaceutical dosage forms of budesonide | Sep 09, 2036 | Sun Pharm Inds Inc |
| Uceris | US10307375 | Controlled release and taste masking oral pharmaceutical composition | Sep 07, 2031 | Salix |
| Uceris | US10660858 | Controlled release and taste masking oral pharmaceutical composition | Sep 07, 2031 | Salix |
| Uceris | US8895064 | Controlled release and taste masking oral pharmaceutical composition | Sep 07, 2031 | Salix |
| Uceris | US9132093 | Controlled release and taste making oral pharmaceutical composition | Sep 07, 2031 | Salix |
| Uceris | US9192581 | Controlled release and taste masking oral pharmaceutical composition | Sep 07, 2031 | Salix |
| Eohilia | US8324192 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | Aug 03, 2029 | Takeda Pharms Usa |
| Eohilia | US9050368 | Corticosteroid compositions | Aug 01, 2029 | Takeda Pharms Usa |
| Tarpeyo | US8491932 | Compositions for the oral delivery of corticosteroids | May 07, 2029 | Calliditas |
| Eohilia | US10293052 | Compositions for the treatment of gastrointestinal inflammation | Nov 22, 2028 | Takeda Pharms Usa |
| Eohilia | US11357859 | Compositions for the treatment of gastrointestinal inflammation | Nov 12, 2028 | Takeda Pharms Usa |
| Eohilia | US11197822 | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract | Nov 09, 2026 | Takeda Pharms Usa |
| Eohilia | US11413296 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | Nov 09, 2026 | Takeda Pharms Usa |
| Eohilia | US8497258 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | Nov 09, 2026 | Takeda Pharms Usa |
| Eohilia | US8679545 | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract | Nov 09, 2026 | Takeda Pharms Usa |
| Eohilia | US8975243 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | Nov 09, 2026 | Takeda Pharms Usa |
| Eohilia | US9119863 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | Nov 09, 2026 | Takeda Pharms Usa |
| Uceris | US10064878 | Controlled release and taste masking oral pharmaceutical compositions |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US10105374 | Controlled release and taste masking oral pharmaceutical compositions |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US10143698 | Controlled release and taste masking oral pharmaceutical compositions |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US7410651 | Controlled release and taste masking oral pharmaceutical composition |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US7431943 | Controlled release and taste masking oral pharmaceutical compositions |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US8293273 | Controlled release and taste masking oral pharmaceutical composition |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US8784888 | Controlled release and taste masking oral pharmaceutical composition |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US9320716 | Controlled release and taste masking oral pharmaceutical compositions |
Jun 09, 2020
(Expired) | Salix |
| Uceris | US9532954 | Controlled release and taste masking oral pharmaceutical compositions |
Jun 09, 2020
(Expired) | Salix |
| Uceris | USRE43799 | Controlled release and taste masking oral pharmaceutical composition |
Jun 09, 2020
(Expired) | Salix |
| Pulmicort Respules |
US6598603 (Pediatric) | Method for treating respiratory diseases |
Jun 23, 2019
(Expired) | Astrazeneca |
| Pulmicort Respules |
US6899099 (Pediatric) | Method for treating a respiratory disease |
Jun 23, 2019
(Expired) | Astrazeneca |
| Pulmicort Respules |
US7524834 (Pediatric) | Sterile powders, formulations, and methods for producing the same |
May 11, 2019
(Expired) | Astrazeneca |
| Pulmicort Respules | US6598603 | Method for treating respiratory diseases |
Dec 23, 2018
(Expired) | Astrazeneca |
| Pulmicort Respules | US6899099 | Method for treating a respiratory disease |
Dec 23, 2018
(Expired) | Astrazeneca |
| Pulmicort Respules | US7524834 | Sterile powders, formulations, and methods for producing the same |
Nov 11, 2018
(Expired) | Astrazeneca |
| Pulmicort Flexhaler | US6142145 | Inhalation device |
May 08, 2018
(Expired) | Cheplapharm |
| Pulmicort Flexhaler | US7143764 | Inhalation device |
Mar 13, 2018
(Expired) | Cheplapharm |
| Pulmicort Flexhaler | US6027714 | Formulation for inhalation |
Jan 09, 2018
(Expired) | Cheplapharm |
| Pulmicort Flexhaler | US6287540 | Formulation for inhalation |
Jan 09, 2018
(Expired) | Cheplapharm |
| Rhinocort |
US6291445 (Pediatric) | Low dose budesonide formulations and uses thereof |
Oct 29, 2017
(Expired) | Astrazeneca |
| Rhinocort |
US6686346 (Pediatric) | Formulation |
Oct 29, 2017
(Expired) | Astrazeneca |
| Rhinocort |
US6986904 (Pediatric) | Formulation |
Oct 29, 2017
(Expired) | Astrazeneca |
| Rhinocort | US6291445 | Low dose budesonide formulations and uses thereof |
Apr 29, 2017
(Expired) | Astrazeneca |
| Rhinocort | US6686346 | Formulation |
Apr 29, 2017
(Expired) | Astrazeneca |
| Rhinocort | US6986904 | Formulation |
Apr 29, 2017
(Expired) | Astrazeneca |
| Uceris | US5914122 | Stable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foams |
Dec 19, 2015
(Expired) | Salix |
| Entocort Ec |
US5643602 (Pediatric) | Oral composition for the treatment of inflammatory bowel disease |
Jan 01, 2015
(Expired) | Padagis Us |
| Entocort Ec | US5643602 | Oral composition for the treatment of inflammatory bowel disease |
Jul 01, 2014
(Expired) | Padagis Us |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Budesonide's patents.
Latest Legal Activities on Budesonide's Patents
Given below is the list recent legal activities going on the following patents of Budesonide.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 10 Jun, 2024 | US8293273(Litigated) |
| Expire Patent Critical | 03 Jun, 2024 | US9320716 |
| Email Notification Critical | 27 Mar, 2024 | US11896719 |
| Patent eCofC Notification | 26 Mar, 2024 | US11896719 |
| Mail Patent eCofC Notification | 26 Mar, 2024 | US11896719 |
| Email Notification Critical | 26 Mar, 2024 | US11896719 |
| Recordation of Patent eCertificate of Correction | 26 Mar, 2024 | US11896719 |
| Post Issue Communication - Certificate of Correction | 05 Mar, 2024 | US11896719 |
| Recordation of Patent eGrant | 13 Feb, 2024 | US11896719 |
| Email Notification Critical | 13 Feb, 2024 | US11896719 |
Budesonide's Family Patents
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Budesonide Generic API Manufacturers
Several generic applications have been filed for Budesonide. The first generic version for Budesonide was by Teva Pharmaceuticals Usa and was approved on Nov 18, 2008. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Nov 29, 2023.
Given below is the list of companies who have filed for Budesonide generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 9MG | tablet, extended release | Prescription | ORAL | AB | Jul 3, 2018 |
2. AMNEAL PHARMS
Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Amneal Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Prescription | ORAL | AB | Jul 31, 2017 |
3. APOTEX
Apotex Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.032MG/SPRAY | spray, metered | Over the counter | NASAL | N/A | Nov 20, 2015 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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4. APOTEX INC
Apotex Inc Richmond Hill has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Apotex Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.032MG/INH | spray, metered | Prescription | NASAL | N/A | May 12, 2014 |
Manufacturing Plant Locations New
Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| Canada |
| |||||||
5. AUROBINDO PHARMA USA
Aurobindo Pharma Usa Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Prescription | ORAL | AB | May 16, 2011 |
Manufacturing Plant Locations New
Aurobindo Pharma Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Usa as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
6. BARR LABS DIV TEVA
Barr Laboratories Inc Sub Teva Pharmaceuticals Usa has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Barr Labs Div Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Discontinued | ORAL | N/A | Apr 2, 2014 |
7. CIPLA
Cipla Ltd has filed for 3 different strengths of generic version for Budesonide. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG/2ML | suspension | Prescription | INHALATION | AN | Nov 16, 2017 |
| 0.25MG/2ML | suspension | Prescription | INHALATION | AN | Nov 16, 2017 |
| 1MG/2ML | suspension | Prescription | INHALATION | AN | Nov 16, 2017 |
Manufacturing Plant Locations New
Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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8. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Prescription | ORAL | AB | Apr 8, 2016 |
9. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG/2ML | suspension | Discontinued | INHALATION | N/A | Nov 29, 2023 |
Manufacturing Plant Locations New
Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| India |
| |||||||
10. IMPAX LABS INC
Impax Laboratories Inc has filed for 2 different strengths of generic version for Budesonide. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.25MG/2ML | suspension | Prescription | INHALATION | AN | Jul 31, 2012 |
| 0.5MG/2ML | suspension | Prescription | INHALATION | AN | Jul 31, 2012 |
11. LUPIN
Lupin Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Lupin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG/2ML | suspension | Prescription | INHALATION | AN | Nov 9, 2018 |
Manufacturing Plant Locations New
Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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12. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 9MG | tablet, extended release | Prescription | ORAL | AB | Sep 17, 2020 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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13. NATCO
Natco Pharma Ltd has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Natco.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Discontinued | ORAL | N/A | Nov 23, 2016 |
Manufacturing Plant Locations New
Natco's manufacturing plants are situated in 2 countries - United Kingdom, India. Given below are the details of these plant locations as well as the firm names of Natco as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom |
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| India |
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14. NEPHRON
Nephron Pharmaceuticals Corporation has filed for 2 different strengths of generic version for Budesonide. Given below are the details of the strengths of this generic introduced by Nephron.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG/2ML | suspension | Prescription | INHALATION | AN | Mar 30, 2009 |
| 0.25MG/2ML | suspension | Prescription | INHALATION | AN | Mar 30, 2009 |
Manufacturing Plant Locations New
Nephron's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Nephron as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||
15. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Padagis Israel.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2MG/ACTUATION
(reference standard) | aerosol, foam | Prescription | RECTAL | AB | Apr 12, 2023 |
Manufacturing Plant Locations New
Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| Israel |
| |||
16. RISING
Rising Pharma Holdings Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Prescription | ORAL | AB | Apr 7, 2017 |
Manufacturing Plant Locations New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Mexico |
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| India |
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17. SANDOZ
Sandoz Inc has filed for 3 different strengths of generic version for Budesonide. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/2ML | suspension | Discontinued | INHALATION | N/A | Sep 27, 2013 |
| 0.25MG/2ML | suspension | Discontinued | INHALATION | N/A | Sep 27, 2013 |
| 0.5MG/2ML | suspension | Discontinued | INHALATION | N/A | Sep 27, 2013 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
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| United States |
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| Spain |
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| India |
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18. SCIECURE PHARMA INC
Sciecure Pharma Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Sciecure Pharma Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Discontinued | ORAL | N/A | Sep 28, 2017 |
19. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Budesonide. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.25MG/2ML | suspension | Prescription | INHALATION | AN | Apr 14, 2021 |
| 0.5MG/2ML | suspension | Prescription | INHALATION | AN | Apr 14, 2021 |
| 1MG/2ML | suspension | Prescription | INHALATION | AN | Apr 14, 2021 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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20. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Budesonide. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.25MG/2ML | suspension | Prescription | INHALATION | AN | Nov 18, 2008 |
| 0.5MG/2ML | suspension | Prescription | INHALATION | AN | Nov 18, 2008 |
21. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/2ML | suspension | Prescription | INHALATION | AN | Mar 8, 2016 |
22. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Budesonide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | capsule, delayed release | Prescription | ORAL | AB | May 4, 2017 |