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Istradefylline - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for istradefylline and what is the scope of freedom to operate?
Istradefylline
is the generic ingredient in one branded drug marketed by Kyowa Kirin and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Istradefylline has sixty-three patent family members in eighteen countries.
There is one drug master file entry for istradefylline. One supplier is listed for this compound.
Summary for istradefylline
| International Patents: | 63 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 75 |
| Clinical Trials: | 21 |
| Patent Applications: | 392 |
| DailyMed Link: | istradefylline at DailyMed |
Recent Clinical Trials for istradefylline
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kyowa Hakko Kirin Company, Limited | Phase 1 |
| Kyowa Hakko Kirin Pharma, Inc. | Phase 1 |
| Kyowa Hakko Kirin Pharma, Inc. | Phase 3 |
US Patents and Regulatory Information for istradefylline
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for istradefylline
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2004275646 | Start Trial |
| European Patent Office | 1676578 | Start Trial |
| Australia | 2004236101 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
