AZACITIDINE - Generic Drug Details

What are the generic drug sources for azacitidine and what is the scope of patent protection?

Azacitidine is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin, Meitheal, Msn Labs Pvt Ltd, Natco Pharma Ltd, Pharmobedient, Reliance Life, Shilpa Medicare, Bristol-myers, and Bristol, and is included in eighteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are fifteen drug master file entries for azacitidine. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AZACITIDINE

International Patents:	102
US Patents:	3
Tradenames:	3
Applicants:	18
NDAs:	18
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	723
Patent Applications:	4,611
Drug Prices:	Drug price trends for AZACITIDINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZACITIDINE
What excipients (inactive ingredients) are in AZACITIDINE?	AZACITIDINE excipients list
DailyMed Link:	AZACITIDINE at DailyMed

See drug prices for AZACITIDINE

Recent Clinical Trials for AZACITIDINE

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

Sponsor	Phase
Prajwal Dhakal	PHASE2
Swedish Orphan Biovitrum	PHASE2
Break Through Cancer Foundation	PHASE1

See all AZACITIDINE clinical trials

Generic filers with tentative approvals for AZACITIDINE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AZACITIDINE

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

Medical Subject Heading (MeSH) Categories for AZACITIDINE

Antimetabolites, Antineoplastic

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AZACITIDINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for AZACITIDINE

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 AZACITIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn Labs Pvt Ltd	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	212580-001	May 16, 2024	AP	RX	No	No
Reliance Life	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	217453-001	May 20, 2025	AP	RX	No	No
Lupin	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	210748-001	Feb 27, 2019		DISCN	No	No
Eugia Pharma	AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215066-001	Dec 30, 2022	AP	RX	No	No

EU/EMA Drug Approvals for AZACITIDINE

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
betapharm Arzneimittel GmbH	Azacitidine betapharm	azacitidine	EMEA/H/C/005075Azacitidine betapharm 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 % to 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification,AML with > 30 % marrow blasts according to the WHO classification.	Authorised	yes	no	no	2020-03-24

International Patents for AZACITIDINE

Country	Patent Number	Title	Estimated Expiration
Argentina	071808
Australia	2009246926
Australia	2013202665
Australia	2015202884

Last updated: July 27, 2026

Azacitidine market dynamics and financial trajectory: pricing, demand drivers, exclusivity, and competitive pressure (US and key ex-US markets)

Azacitidine is a foundational hypomethylating agent (HMA) used in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) in patients not suitable for intensive chemotherapy. The financial trajectory of azacitidine products is shaped by (1) consolidation of leading brands in major markets, (2) payer pressure and tendering on price and dose economics, (3) competitive migration toward venetoclax-based combinations for AML, and (4) the expansion of alternative HMAs and oral regimens where available. In the US, sales and profitability are also influenced by FDA pathway execution, generic/biosimilar entry timing for specific dosage forms (where applicable), and patent-litigation outcomes affecting formulation or method-of-use exclusivity.

What to know upfront about azacitidine commercial exposure

• Therapeutic anchor: MDS and AML (transfusion-dependent anemia and higher-risk disease segments drive persistence).
• Competitive battlefield: venetoclax combinations in AML are the principal share-risk vector; in MDS, HMAs remain core, but switching behavior is payer- and patient-driven.
• Business sensitivity: revenue is exposed to dose modifications, discontinuation rates, and the mix of baseline risk groups (newly diagnosed vs relapsed).
• Market structure: branded liquid and lyophilized presentations are typically priced under negotiated US payer contracts; ex-US markets follow national reimbursement rules and wholesaler tendering.

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How big is the azacitidine market and what are the main demand drivers?

Featured snippet answer: Azacitidine demand is driven by HMA-treated patient pools in higher-risk MDS and AML-ineligible populations, with persistence influenced by response depth, transfusion independence, and payer support for continued cycles.

Disease segments that most affect volume

1. Higher-risk MDS
   • Core usage in patients with increased blast percentage and unfavorable cytogenetics.
   • Real-world persistence depends on cytopenia tolerance, dose schedule adherence, and risk of progression.
2. AML not suitable for intensive chemotherapy
   • HMAs are used as backbone therapy, but venetoclax regimens increasingly compete on response rates.
3. Second-line and relapsed settings
   • Switching patterns depend on prior HMA exposure and local guidance.

Major macro demand drivers

• Aging demographics that expand the MDS/AML-ineligible population.
• Diagnostic intensity that increases referrals to hematology-oncology.
• Guideline reinforcement of HMA use where transplant/induction is not feasible.

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Which azacitidine products generate revenue and how do formulations affect commercial outcomes?

Featured snippet answer: Azacitidine revenue depends on which manufacturer holds the dominant reimbursed product presentation (e.g., ready-to-use vs reconstituted formats) and whether substitution is permitted by payers and formularies.

Product-level commercial mechanics

• Tender and contract structure: negotiated acquisition cost drives gross-to-net dilution.
• Administration workflow:
  • Ready-to-use formats can reduce pharmacy burden and improve site adoption.
  • Lyophilized formats can face additional operational constraints in community settings.
• Dose schedule: HMAs are cyclical; adherence affects realized dose delivered and thus total revenue.

Mix effects inside azacitidine

• MDS mix usually supports steadier baseline demand.
• AML mix is more sensitive to competitive introductions and evolving combination standards.

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What pricing and payer dynamics determine azacitidine gross-to-net and net revenue?

Featured snippet answer: Azacitidine net revenue is driven by US payer contracting, discounts and rebates, and channel mix (IDNs vs community), with additional pressure when competitors deliver lower acquisition cost or when formularies tighten.

US payer pressures that typically move azacitidine profitability

• PBM rebate structures and formulary tiering changes after competitor entries.
• Use of value-based contracting where response outcomes are incorporated into reimbursement.
• 340B and covered entity economics affecting provider purchasing patterns.
• White bagging and specialty distribution altering net realized price and channel inventory costs.

Ex-US pricing forces

• National health system negotiations and reference pricing.
• Tendering and procurement that drives downward price bands after competitive supply normalizes.

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How does venetoclax-based AML therapy affect azacitidine market share and financial trajectory?

Featured snippet answer: Venetoclax combinations are the main financial risk to azacitidine in AML, shifting some patients away from HMA monotherapy toward combination regimens where clinical response and depth-of-response benchmarks are prioritized.

Share-risk pathways

• Line-of-therapy displacement: venetoclax-HMA combinations can move HMAs from monotherapy to combination contexts.
• Institutional guideline adoption: academic centers tend to accelerate combination adoption.
• Payer authorization: coverage of venetoclax combinations can displace HMA monotherapy, reducing azacitidine’s standalone prescription volume.

Offset factors

• MDS continued growth: most intense competitive pressure is in AML.
• Patient contraindications to venetoclax regimens can sustain HMA monotherapy use.

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Which competitors pressure azacitidine in MDS and AML?

Featured snippet answer: Azacitidine faces pressure from alternative HMAs and from AML combination standards; the strongest demand substitution risk typically comes from venetoclax plus HMA regimens in AML and from other HMAs where payer contracts favor them.

Competitive set (commercial relevance)

• Other HMAs used in MDS/AML contexts:
  • Decitabine-based regimens.
• Targeted combination standards for AML:
  • Venetoclax with HMAs.
• Potential uptake of novel regimens:
  • Agents targeting disease biology or immune pathways can shift treatment sequences as evidence and reimbursement expand.

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How does exclusivity and patent protection shape azacitidine product stability and generic entry risk?

Featured snippet answer: Patent estate strength and the status of formulation or method-of-use claims determine the timing and extent of generic entry risk, shaping pricing power and volume stability.

What to check for commercial timing

• Orange Book listings by dosage form and strength.
• Listed patents tied to:
  • composition and formulation,
  • manufacturing processes,
  • method of use.
• Paragraph IV filings that trigger 30-month stay and settlement dynamics.
• Exclusivity:
  • new drug exclusivity (if applicable historically),
  • orphan exclusivity (if applicable to specific indications).

Litigation and settlement impacts (what matters financially)

• If litigation blocks generic launch: branded stability and reduced price erosion.
• If settlement accelerates entry:
  • earlier-than-expected volume loss,
  • steeper pricing concessions.

(Patent and Orange Book–specific status cannot be populated here without product-specific Orange Book data and litigation docket details.)

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What is the Orange Book status of azacitidine and what is the litigation landscape affecting entry?

Featured snippet answer: Orange Book status, including listed patents by NDA, and the presence of ANDA Paragraph IV cases, drive market expectations for generic entry and price declines.

How to map Orange Book to revenue exposure

• Patent expiry schedules by listed claim set.
• Patent-by-patent challenge likelihood:
  • formulation/process claims can be harder to design around,
  • method-of-use claims depend on proposed labeling and inducement exposure.
• Settlement structures:
  • “launch date” commitments,
  • royalty-bearing supply or reverse payment frameworks (where permitted),
  • carve-outs for non-infringing presentations.

(Specific Orange Book patent numbers, assignees, and expiry dates require Orange Book dataset extraction for the exact azacitidine NDA(s) and dosage forms.)

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When does azacitidine lose exclusivity and what launch scenarios typically follow?

Featured snippet answer: Exclusivity loss typically opens the window for ANDA launches; the realized commercial impact depends on (1) which strengths and presentations are covered, (2) whether payers allow substitution, and (3) whether settlements delay or condition entry.

Generic launch scenario drivers

• Inventory timing: branded supply and channel stocking pre-expiry.
• Payer substitution policy: automatic substitution versus prior authorization.
• Manufacturing readiness:
  • compliance and release timelines,
  • fill finish capacity for sterile products.

Likely pricing pattern post-entry

• Initial price pressure concentrates on the most interchangeable strengths.
• Secondary erosion follows as additional ANDAs enter or as wholesaler discounts normalize.

(No calendar-specific dates are provided here because exclusivity and patent expiration must be sourced from Orange Book for the relevant azacitidine NDA(s).)

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How do reimbursement and treatment guidelines affect azacitidine persistence and total treatment cost?

Featured snippet answer: Azacitidine financial performance tracks patient persistence because HMAs require multiple cycles; reimbursement stability and guideline endorsements influence discontinuation rates and switching behavior.

Persistence metrics that typically drive revenue

• Cycle completion in MDS patients.
• Transfusion independence achievement as a proxy for clinician willingness to continue.
• Progression-to-discontinuation timelines.

Total treatment cost considerations

• Dose intensity and scheduling affect per-patient cost.
• Supportive care and administration costs can become decision variables when payer scrutiny rises.

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What is the financial trajectory of azacitidine: revenue growth vs price erosion?

Featured snippet answer: The commercial trajectory of azacitidine generally oscillates between volume gains from expanding HMA-treated populations and price erosion from payer pressure and competitor substitution; profitability is governed by gross-to-net trends and competitive timing rather than by unit growth alone.

Revenue trajectory mechanics

• Early lifecycle: volume growth dominates.
• Maturity: gross-to-net becomes the primary lever.
• Post-generic/patent expiry: channel price erosion and volume reallocation dominate earnings outcomes.

Profitability drivers (what changes quarter to quarter)

• Contracting outcomes with large payers and IDNs.
• Channel inventory positions around exclusivity milestones.
• Mix between MDS and AML indications.
• Manufacturing costs for sterile supply chains.

(Quantitative financial trajectory requires company financial disclosures tied to the relevant NDA holders and product-level revenue reporting, which is not supplied in the prompt.)

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Which investors and buyers care most about azacitidine economics?

Featured snippet answer: Specialty pharma investors and generic entrants focus on exclusivity timelines, payer contracting leverage, manufacturing economics, and the competitive substitution threat from venetoclax-HMA and alternative HMAs.

Buyer/investor decision inputs

• Net price waterfall (list price, discounts, rebates).
• Forecast sensitivity to:
  • AML regimen substitution,
  • MDS patient pool and persistence.
• Regulatory risk:
  • labeling changes,
  • manufacturing inspections,
  • REMS or operational requirements (if any for the specific product).
• Litigation risk:
  • injunction exposure,
  • settlement durability.

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How does azacitidine compare with decitabine and other HMAs for market positioning?

Featured snippet answer: Market positioning depends on comparative adoption driven by dosing convenience, perceived efficacy in clinician practice patterns, and net price under payer contracts; substitution between HMAs is common when reimbursement shifts.

Commercial differentiators

• Formulation and administration burden that impacts institutional choice.
• Historical payer coverage and formulary placement.
• Physician familiarity and treatment protocols already established.

Where substitution tends to occur

• Payer-driven switching after contract renewal cycles.
• Treatment sequence adjustments when AML combination standards expand.

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What manufacturing and supply-chain barriers protect branded azacitidine revenue?

Featured snippet answer: Sterile manufacturing capacity, sterile fill finish constraints, and quality system compliance are recurring barriers that can delay or limit supply during generic transitions, supporting branded sales stability longer than expected.

Barriers that matter

• Sterile aseptic fill/finish complexity.
• Stability testing and shelf-life management tied to formulation specifics.
• Regulatory compliance:
  • batch release delays,
  • inspection outcomes.

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Key Takeaways

• Azacitidine demand is structurally anchored in higher-risk MDS and AML-ineligible populations, but financial trajectory is most sensitive to AML regimen substitution toward venetoclax-HMA combinations.
• Pricing and gross-to-net dynamics dominate earnings outcomes in mature HMAs, with payers driving net realized prices through contracting and rebates.
• Patent estate strength and Orange Book status by dosage form determine generic entry timing; litigation and settlements can materially shift revenue erosion timelines.
• Formulation and administration workflow affect adoption and persistence, influencing realized patient-days and thus revenue.
• Competitive pressure is concentrated where treatment guidelines and payer authorization most strongly favor combination regimens or lower-cost HMAs.

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FAQs

1. How do venetoclax-HMA combination approvals change azacitidine reimbursement in AML?
2. What do payer substitution rules typically look like for azacitidine once an ANDA launches?
3. Which azacitidine dosage forms (strengths or presentations) face the highest generic substitution risk?
4. How do MDS response endpoints like transfusion independence affect azacitidine cycle persistence commercially?
5. What operational constraints most frequently delay sterile injectables market entries for azacitidine?

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References

1. APA style citations: No sources were provided in the prompt; no inline citations can be constructed without external documents.