XROMI Drug Patent Profile
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When do Xromi patents expire, and when can generic versions of Xromi launch?
Xromi is a drug marketed by Nova Labs Ltd and is included in one NDA.
The generic ingredient in XROMI is hydroxyurea. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Xromi
A generic version of XROMI was approved as hydroxyurea by BARR on October 16th, 1998.
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Questions you can ask:
- What is the 5 year forecast for XROMI?
- What are the global sales for XROMI?
- What is Average Wholesale Price for XROMI?
Summary for XROMI
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 1,706 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in XROMI? | XROMI excipients list |
| DailyMed Link: | XROMI at DailyMed |
Pharmacology for XROMI
| Drug Class | Antimetabolite |
US Patents and Regulatory Information for XROMI
XROMI is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting XROMI
TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS AGED 6 MONTHS OF AGE TO LESS THAN 2 YEARS, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISES
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nova Labs Ltd | XROMI | hydroxyurea | SOLUTION;ORAL | 216593-001 | Apr 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
