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Generated: June 26, 2017
What are the generic drug sources for budesonide and what is the scope of budesonide patent protection?
Budesonide is the generic ingredient in nine branded drugs marketed by Apotex Inc, Impax Labs Inc, Mylan, Valeant Pharms Intl, Teva Pharms, Mayne Pharma, Alvogen Malta, Perrigo Pharma Intl, Astrazeneca Pharms, Astrazeneca, Zydus Pharms Usa Inc, Teva Pharms Usa, Sandoz Inc, Appco Pharma Llc, and Barr Labs Div Teva, and is included in twenty-one NDAs. There are thirty-one patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 9 |
| Patents: | 31 |
| Applicants: | 15 |
| NDAs: | 21 |
| Drug Master File Entries: see list | 20 |
| Suppliers / Packagers: see list | 37 |
| Bulk Api Vendors: see list | 93 |
| Clinical Trials: see list | 280 |
| Patent Applications: see list | 8,230 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | budesonide at DailyMed |
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | RX | Yes | Yes | 8,528,545*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | RX | Yes | No | 6,142,145 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Appco Pharma Llc | BUDESONIDE | budesonide | CAPSULE;ORAL | 207367-001 | Apr 7, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Pharms | RHINOCORT ALLERGY | budesonide | SPRAY, METERED;NASAL | 020746-003 | Mar 23, 2015 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | RX | Yes | Yes | 8,616,196*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | PULMICORT | budesonide | POWDER, METERED;INHALATION | 020441-002 | Jun 24, 1997 | 4,524,769 | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | 4,787,536*PED | ► Subscribe | ||||||||||||||||||||||
Astrazeneca | PULMICORT | budesonide | POWDER, METERED;INHALATION | 020441-003 | Jun 24, 1997 | 4,907,583*PED | ► Subscribe | ||||||||||||||||||||||
Valeant Pharms Intl | UCERIS | budesonide | AEROSOL, FOAM;RECTAL | 205613-001 | Oct 7, 2014 | 5,914,122 | ► Subscribe | ||||||||||||||||||||||
Perrigo Pharma Intl | ENTOCORT EC | budesonide | CAPSULE;ORAL | 021324-001 | Oct 2, 2001 | 6,423,340*PED | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,410,652 | Controlled release and taste masking oral pharmaceutical composition | ► Subscribe | |||||||||||||||||||||||||||
| 9,592,203 | Controlled release and taste masking oral pharmaceutical composition | ► Subscribe | |||||||||||||||||||||||||||
| 6,030,604 | Formulation for inhalation | ► Subscribe | |||||||||||||||||||||||||||
| 8,029,823 | Controlled release and taste masking oral pharmaceutical composition | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2003501457 | ► Subscribe | |||||||||||||||||||||||||||
| Italy | 1317871 | ► Subscribe | |||||||||||||||||||||||||||
| Estonia | 9900295 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 1008019 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1019033 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB02/033 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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