Istradefylline - Generic Drug Details
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What are the generic drug sources for istradefylline and what is the scope of patent protection?
Istradefylline
is the generic ingredient in one branded drug marketed by Kyowa Kirin and is included in one NDA. There are three 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: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 25 |
| Patent Applications: | 894 |
| What excipients (inactive ingredients) are in istradefylline? | istradefylline excipients list |
| DailyMed Link: | istradefylline at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for istradefylline
Generic Entry Date for istradefylline*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for istradefylline
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kyowa Kirin, Inc. | Phase 4 |
| Georgetown University | Phase 4 |
| ALS Association | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for istradefylline
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 | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for istradefylline
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for istradefylline
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Kyowa Kirin Holdings B.V. | Nouryant | istradefylline | EMEA/H/C/005308 Istradefylline is indicated in adults as an adjunctive treatment to levodopa based regimens in patients with Parkinson’s disease (PD) experiencing “OFF” time. |
Refused | no | no | no | 2022-01-06 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for istradefylline
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 1626049 | Microcristal de (E)-8-(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione (Microcrystal of (E)-8-(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione) | ⤷ Try a Trial |
| Spain | 2686123 | ⤷ Try a Trial | |
| Japan | 2012140461 | THERAPEUTIC AGENT FOR DYSKINESIS | ⤷ Try a Trial |
| South Korea | 20150080013 | ⤷ Try a Trial | |
| Mexico | PA04007299 | METODOS DE TRATAMIENTO DE PACIENTES QUE SUFREN DE TRASTORNOS DE MOVIMIENTO. (METHODS OF TREATING PATIENTS SUFFERING FROM MOVEMENT DISORDERS.) | ⤷ Try a Trial |
| Taiwan | 200517394 | Method for stabilization of diarylvinylene compounds | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
