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ONUREG Drug Patent 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 and one Paragraph IV challenge.
This drug has seventy-three 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.
DrugPatentWatch® 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: | 73 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 25 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ONUREG |
| What excipients (inactive ingredients) are in ONUREG? | ONUREG excipients list |
| DailyMed Link: | ONUREG at DailyMed |
Recent Clinical Trials for ONUREG
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brian Jonas | Phase 2 |
| AbbVie | Phase 2 |
| Celgene | Phase 1 |
Pharmacology for ONUREG
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ONUREG
Paragraph IV (Patent) Challenges for ONUREG
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ONUREG | TABLET;ORAL | azacitidine | 214120 | 2021-09-30 |
US Patents and Regulatory Information for ONUREG
ONUREG is protected by one US patents and two FDA Regulatory Exclusivities.
Patents protecting ONUREG
Oral formulations of cytidine analogs and methods of use thereof
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
FDA Regulatory Exclusivity protecting ONUREG
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign up for a Free Trial
INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
Exclusivity Expiration: ⤷ Sign up for a Free Trial
| 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 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Celgene Corp | ONUREG | azacitidine | TABLET;ORAL | 214120-002 | Sep 1, 2020 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Celgene Corp | ONUREG | azacitidine | TABLET;ORAL | 214120-001 | Sep 1, 2020 | RX | Yes | No | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free 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 |
|---|---|---|
| Peru | 20142440 | ⤷ Sign up for a Free Trial |
| Russian Federation | 2010151428 | ⤷ Sign up for a Free Trial |
| Slovenia | 2695609 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
