ONUREG Drug Patent Profile

When do Onureg patents expire, and when can generic versions of Onureg launch?

Onureg is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and two patent family members in thirty-five countries.

The generic ingredient in ONUREG is azacitidine. There are fifteen drug master file entries for this compound. Twenty-one 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 16^th, 2013.

Summary for ONUREG

International Patents:	102
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	40
Drug Prices:	Drug price information for ONUREG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONUREG
What excipients (inactive ingredients) are in ONUREG?	ONUREG excipients list
DailyMed Link:	ONUREG at DailyMed

See drug prices for ONUREG

Recent Clinical Trials for ONUREG

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hikma Pharmaceuticals LLC	PHASE1
French Innovative Leukemia Organisation	Phase 2
Acute Leukemia French Association	Phase 2

See all ONUREG clinical trials

Pharmacology for ONUREG

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Paragraph IV (Patent) Challenges for ONUREG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ONUREG	Tablets	azacitidine	200 mg and 300 mg	214120	1	2021-09-30

US Patents and Regulatory Information for ONUREG

ONUREG is protected by three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No	8,846,628		Y
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-002	Sep 1, 2020		RX	Yes	Yes	11,571,436		Y
Bristol	ONUREG	azacitidine	TABLET;ORAL	214120-001	Sep 1, 2020		RX	Yes	No

EU/EMA Drug Approvals for ONUREG

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Vidaza	azacitidine	EMEA/H/C/000978Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification.Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.	Authorised	no	no	no	2008-12-17
Accord Healthcare S.L.U.	Azacitidine Accord	azacitidine	EMEA/H/C/005147Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:- intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),- chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,- acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,- AML with >30% marrow blasts according to the WHO classification.	Authorised	yes	no	no	2020-02-13
Mylan Ireland Limited	Azacitidine Mylan	azacitidine	EMEA/H/C/004984Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification,AML with > 30% marrow blasts according to the WHO classification.	Authorised	yes	no	no	2020-03-27

International Patents for ONUREG

See the table below for patents covering ONUREG around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	071808
Australia	2009246926
Australia	2013202665

Last updated: June 26, 2026

ONUREG market dynamics and financial trajectory: pricing, demand drivers, competition, and exclusivity risk

ONUREG (nemonapride? no) is not a chemotherapy brand and its commercial trajectory depends on treatment uptake in R/R AML and coverage decisions around its safety/efficacy profile. ONUREG’s near-term revenue path is shaped by (1) ongoing conversion of eligible patients after guideline incorporation, (2) payor restrictions and step edits, (3) competing regimens in relapsed/refractory disease, and (4) the tightness of its branded IP and FDA exclusivity status.

What follows is a market-dynamics and financial-trajectory view for ONUREG, including the commercial drivers, pricing pressure vectors, competitive substitution risk, and the specific exclusivity and generic entry timelines that govern revenue durability.

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What is ONUREG and how does its indication scope drive unit demand?

ONUREG is a branded oncology product tied to a specific, narrow patient population. Market size is therefore set less by “broad label” mechanics and more by: (a) the incident pool of patients reaching the relapsed/refractory stage, (b) diagnostic funnel (biomarker and disease characterization), and (c) physician sequencing behavior.

Key commercial demand drivers

• Patient pool definition: uptake rises when physicians view the label as aligned with real-world eligibility (prior therapy history, performance status, and disease characteristics).
• Line-of-therapy fit: oncology brands with clear positioning in second-line or later phases tend to show steadier demand if they match standard sequencing.
• Administration and adherence economics: regimen schedule and supportive-care requirements influence office/hospital workflow and payor approval friction.

Key limitations on volume scaling

• Small addressable population: revenue tends to depend on retention and share-of-eligible-patients rather than overall market expansion.
• Payor gating: restricted formularies, prior authorization, and coverage caps can materially slow adoption even after clinical guideline updates.

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How much revenue does ONUREG generate and what is the financial trajectory?

A revenue trajectory analysis requires confirmed financial statements or credible market-research revenue data for ONUREG by period and geography. Without a verifiable revenue series, any “trajectory” would be speculative and risks misstatement.

No revenue or financial trajectory data is provided here because it is not verifiable from the available inputs.

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What pricing and reimbursement dynamics affect ONUREG sales?

Pricing pressure in specialty oncology typically comes from three channels: net price dilution, channel mix, and utilization constraints.

Net price drivers

• Contracting rebates and discounts: specialty oncology products often realize materially lower net prices than WAC.
• 340B and institutional purchasing mix: shifts in provider mix affect realized net.
• Step edits and prior authorization: payors can require failure on alternative regimens, reducing immediate uptake.

Reimbursement friction points that change adoption curve shape

• Coverage determination speed: delays reduce first-course conversion.
• Clinical criteria matching: if real-world use diverges from label assumptions, payors can tighten criteria.

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What competitive regimens threaten ONUREG share in relapsed/refractory oncology?

In oncology, share loss often comes from:

• similar efficacy profiles with better safety tolerability,
• oral convenience or lower administration burden,
• combination strategies that alter sequencing,
• and biosimilar or generic substitutions are not typically the first threat for cell-cycle–targeted specialty regimens, but alternative branded therapies are.

Substitution risk mechanics

• Guideline displacement: if a competing regimen becomes preferred, ONUREG’s share-of-eligible-patients declines even if its label remains unchanged.
• Real-world safety tradeoffs: higher discontinuation rates or monitoring burden can cause clinicians to shift away.
• Access barriers: if a competitor is “easier” to get approved, it can win early adoption.

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When does ONUREG lose exclusivity, and what is the risk of generic or biosimilar entry?

For branded small-molecule oncology drugs, the main revenue protection layers are:

• composition-of-matter patents (primary term),
• method-of-use patents (indication-specific),
• formulation and manufacturing patents (secondary term),
• and any regulatory exclusivity tied to the NDA/BLA approval pathway.

No exclusivity dates or Orange Book status are provided here because they are not present in the available inputs.

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What is the Orange Book status of ONUREG and how many listed patents block generic entry?

Orange Book status determines both:

1. whether generic applicants can submit an ANDA, and
2. which patent numbers and expiration dates govern Paragraph IV triggers.

No Orange Book listing or patent-count data is provided because it is not available in the input information.

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Which Paragraph IV challenges target ONUREG, and what settlements or litigation outcomes matter?

Paragraph IV litigation typically dictates:

• whether a generic launches “at risk,”
• whether a settlement triggers a delayed launch or narrower carve-outs,
• and whether exclusivity is preserved until the scheduled end of regulatory and patent protection.

No Paragraph IV cases, litigation docket outcomes, or settlement terms are provided because they are not present in the available inputs.

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What formulation or method-of-use patents protect ONUREG specifically?

Secondary patents can extend exclusivity by protecting:

• dosing regimens (method-of-use),
• patient subpopulations and endpoints,
• crystalline forms, solvates, salts, or polymorphs (composition-level extensions),
• controlled-release and stability enhancements (formulation),
• and validated manufacturing improvements.

No ONUREG patent-family mapping is included because patent identifiers, claims, and assignees are not provided in the available inputs.

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How does ONUREG compare with competing oncology brands on adoption, access, and payer response?

A credible comparative assessment requires:

• labeled indications and line-of-therapy position,
• dosing schedules and administration costs,
• safety profiles that drive prior authorization criteria,
• and payor contracting patterns.

No comparative market-access metrics are provided because the inputs do not include payer policies, utilization, or adoption data.

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What manufacturing and IP barriers slow down generic or biosimilar substitution for ONUREG?

For small molecules, generic substitution barriers typically come from:

• formulation-specific patents,
• manufacturing process claims,
• and freedom-to-operate constraints around polymorph or solid-state form.

No manufacturing/IP barrier assessment is provided because ONUREG-specific patent claims and process details are not available in the input information.

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Where is ONUREG commercial exposure highest by geography and channel?

Geographic and channel exposure is usually modeled from:

• hospital vs community share,
• reimbursement systems (US vs EU vs ROW),
• and tender dynamics in government or semi-government systems.

No geography/channel revenue breakdown is provided because it is not available in the available inputs.

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Key Takeaways

• ONUREG’s market dynamics depend on eligible patient pool conversion, coverage and prior authorization behavior, and competitive sequencing pressure in relapsed/refractory care.
• A revenue and financial-trajectory view requires a verified sales/revenue series and confirmed FDA/patent timelines; those are not present in the input information.
• Exclusivity risk, generic launch scenarios, and litigation outcomes are determinative for durability of branded cash flows, but Orange Book status and Paragraph IV/litigation data are not provided in the available inputs.

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FAQs

1. How do prior authorization and step edits typically change oncology brand adoption curves like ONUREG?
2. What patent layers (composition-of-matter vs method-of-use vs formulation) most often extend revenue for specialty oncology drugs?
3. How do guideline updates and consensus treatment pathways affect share-of-eligible-patients for relapsed/refractory oncology brands?
4. What settlement structures most commonly delay generic entry in Paragraph IV cases?
5. What real-world discontinuation and safety monitoring factors drive payer restrictions for oncology therapies?

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References (APA)

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