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Itraconazole - Generic Drug Details
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This ingredient has forty-nine patent family members in thirty-three countries.
There are fifteen drug master file entries for itraconazole. Seven suppliers are listed for this compound.
Summary for Generic Name: itraconazole
| Tradenames: | 3 |
| Patents: | 5 |
| Applicants: | 6 |
| NDAs: | 8 |
| Drug Master File Entries: see list | 15 |
| Suppliers / Packaging: see list | 7 |
| Therapeutic Class: | Antifungals |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: itraconazole
| Ingredient-type | Azoles |
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Clinical Trials for: itraconazole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | RX | Yes | 6,407,079 | Jun 18, 2019 | ||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | RX | Yes | ||||||||||||||||||||||
Sandoz | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 076104-001 | May 28, 2004 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: itraconazole
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | 4,267,179 | <disabled> | ||||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | 4,727,064 | <disabled> | ||||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | 4,791,111 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: itraconazole
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,149,431 | Itraconazole compositions with improved bioavailability | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Ingredient: itraconazole
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 0904060 | <disabled in preview> | |||||||||||||||||||||||||||
| Hong Kong | 1018002 | <disabled in preview> | |||||||||||||||||||||||||||
| Austria | 255883 | <disabled in preview> | |||||||||||||||||||||||||||
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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.
Export unavailable in trial.
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How are People Using DrugPatentWatch?
To proactively manage the hospital's pharmaceutical inventory
— Hospital pharmacist, USA
To find information on expiration dates of patents in the Netherlands
— Hospital pharmacist, Netherlands
To gain information on when to expect generics on the market in order to inform patients of when they can expect more affordable drugs
— Retail pharmacist, USA
To get patent expiration dates and find out when generics plan to advertise and enter the market
— Pharmacist, USA
For a comprehensive list of patents, along with their details, for some drug molecules
— Business analyst, India
To identify drug patent expiration dates for pharmaceutical companies
— Investment analyst, USA
To follow up on status of patents in Colombia and other Latin American countries
— Business development, Colombia
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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