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ACCRUFER Drug Profile
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See Plans and PricingWhen do Accrufer patents expire, and what generic alternatives are available?
Accrufer is a drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this drug.
This drug has forty-three patent family members in seventeen countries.
The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. Additional details are available on the ferric maltol profile page.
US ANDA Litigation and Generic Entry Outlook for Accrufer
Accrufer will be eligible for patent challenges on July 25, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 23, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ACCRUFER
| International Patents: | 43 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | ACCRUFER at DailyMed |
Generic Entry Opportunity Date for ACCRUFER
Generic Entry Date for ACCRUFER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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.
US Patents and Regulatory Information for ACCRUFER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320-001 | Jul 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320-001 | Jul 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320-001 | Jul 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 ACCRUFER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 251863 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016066555 | Start Trial |
| Australia | 2009247762 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
