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ONUREG Drug Profile
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When do Onureg patents expire, and when can generic versions of Onureg launch?
Onureg is a drug marketed by Celgene Corp and is included in one NDA. There is one patent protecting this drug.
This drug has sixty-nine patent family members in thirty-four countries.
The generic ingredient in ONUREG is azacitidine. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
US ANDA Litigation and Generic Entry Outlook for Onureg
A generic version of ONUREG was approved as azacitidine by DR REDDYS on September 16th, 2013.
Summary for ONUREG
| International Patents: | 69 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ONUREG |
| DailyMed Link: | ONUREG at DailyMed |
Pharmacology for ONUREG
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
US Patents and Regulatory Information for ONUREG
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celgene Corp | ONUREG | azacitidine | TABLET;ORAL | 214120-001 | Sep 1, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Celgene Corp | ONUREG | azacitidine | TABLET;ORAL | 214120-002 | Sep 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | ONUREG | azacitidine | TABLET;ORAL | 214120-001 | Sep 1, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | ONUREG | azacitidine | TABLET;ORAL | 214120-002 | Sep 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | 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 ONUREG
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 6300930 | Start Trial |
| South Africa | 201008229 | Start Trial |
| Ukraine | 101370 | Start Trial |
| Mexico | 2010012470 | Start Trial |
| Ukraine | 111331 | Start Trial |
| European Patent Office | 3692983 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
