Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: July 22, 2017
What are the generic drug sources for itraconazole and what is the scope of itraconazole freedom to operate?
Itraconazole is the generic ingredient in three branded drugs marketed by Sandoz, Par Pharm Inc, Alembic Pharms Ltd, Jubilant Generics, Janssen Pharms, Mylan Pharms Inc, Amneal Pharms, Sebela Ireland Ltd, Accord Hlthcare, and Alkem Labs Ltd, and is included in thirteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 6 |
| Applicants: | 10 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 15 |
| Suppliers / Packagers: see list | 16 |
| Bulk Api Vendors: see list | 102 |
| Clinical Trials: see list | 171 |
| Patent Applications: see list | 6,407 |
| Therapeutic Class: | Antifungals |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | itraconazole at DailyMed |
| Ingredient-type | Azoles |
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal Pharms | ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 205573-001 | Oct 30, 2015 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | RX | Yes | Yes | 7,081,255 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Alembic Pharms Ltd | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 206741-001 | Dec 13, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Par Pharm Inc | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 205724-001 | Dec 13, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | 7,081,255 | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | 4,267,179 | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | 4,727,064 | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | 4,267,179 | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | 4,791,111 | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2571032 | ► Subscribe | |||||||||||||||||||||||||||
| Turkey | 9801225 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2956297 | ► Subscribe | |||||||||||||||||||||||||||
| Estonia | 9800304 | ► Subscribe | |||||||||||||||||||||||||||
| Estonia | 03902 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Subscribe for complete access.
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.
Follow DrugPatentWatch:
Join the 22,079 other biopharmaceutical professionals who get our Drug Patent Expiration Alerts:
