REVLIMID Drug Patent Profile

When do Revlimid patents expire, and what generic alternatives are available?

Revlimid is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and thirty-one patent family members in forty-one countries.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Revlimid

A generic version of REVLIMID was approved as lenalidomide by ARROW INTL on May 21^st, 2021.

Summary for REVLIMID

International Patents:	331
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	555
Patent Applications:	4,117
Drug Prices:	Drug price information for REVLIMID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REVLIMID
What excipients (inactive ingredients) are in REVLIMID?	REVLIMID excipients list
DailyMed Link:	REVLIMID at DailyMed

See drug prices for REVLIMID

Recent Clinical Trials for REVLIMID

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
Tanta University	PHASE4
City of Hope Medical Center	Phase 2

See all REVLIMID clinical trials

Pharmacology for REVLIMID

Drug Class

Thalidomide Analog

Paragraph IV (Patent) Challenges for REVLIMID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REVLIMID	Capsules	lenalidomide	2.5 mg and 20 mg	021880	1	2016-07-12
REVLIMID	Capsules	lenalidomide	5 mg, 10 mg and 15 mg	021880	1	2010-08-30
REVLIMID	Capsules	lenalidomide	25 mg	021880	1	2010-07-12

US Patents and Regulatory Information for REVLIMID

REVLIMID is protected by two US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	AB	RX	Yes	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No			Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	AB	RX	Yes	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No

Expired US Patents for REVLIMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005

EU/EMA Drug Approvals for REVLIMID

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Lenalidomide Mylan	lenalidomide	EMEA/H/C/005306Multiple myelomaLenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Follicular lymphomaLenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).	Authorised	yes	no	no	2020-12-18
Accord Healthcare S.L.U.	Lenalidomide Accord	lenalidomide	EMEA/H/C/004857Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Follicular lymphomaLenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Authorised	yes	no	no	2018-09-20
Bristol-Myers Squibb Pharma EEIG	Revlimid	lenalidomide	EMEA/H/C/000717Multiple myelomaRevlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesRevlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaRevlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Authorised	no	no	no	2007-06-14
Krka, d.d., Novo mesto	Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)	lenalidomide	EMEA/H/C/005348Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Authorised	yes	no	no	2021-02-11

International Patents for REVLIMID

When does loss-of-exclusivity occur for REVLIMID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering REVLIMID around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	229521
Austria	275139
Austria	401319
Austria	460409

Supplementary Protection Certificates for REVLIMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294	91359	Luxembourg		91359, EXPIRES: 20220614
0925294	CA 2007 00054	Denmark		PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
0925294	07C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
0925294	SPC033/2007	Ireland		SPC033/2007: 20080507, EXPIRES: 20220613

Revlmid (lenalidomide) Market Dynamics and Financial Trajectory: Pricing, Volume Drivers, Exclusivity Expiry, and Generic/Biosimilar Risk

Last updated: July 24, 2026

Executive summary

• Lenalidomide (REVLIMID) is a long-running, high-revenue multiple-myeloma franchise with market dynamics driven by: (i) ongoing uptake in combination regimens (e.g., with dexamethasone, daratumumab, and other backbone therapies), (ii) dose intensity and adherence effects on response depth, (iii) payer controls tied to net price, rebates, and access restrictions, and (iv) supply normalization after historic brand manufacturing disruptions.
• Financial trajectory is dominated by net pricing versus volume rather than pure growth: the market expands mainly where guidelines and evidence increase eligible lines of therapy and where prescriber inertia and REMS-linked operations support steady demand.
• Generic entry risk is material for value, but the economic cliff depends on (a) paragraph IV and other patent litigation outcomes for specific commercial formulations and manufacturing/process claims and (b) settlement-triggered “at-risk” timing. For lenalidomide, the patent landscape has historically allowed the brand to sustain premium pricing beyond first filing expectations.
• Near-term downside is mainly pricing pressure (rebate growth, formulary tightening, and international trade-offs), not an immediate demand collapse; upside is linked to sustained regimen usage and geography expansion where access remains less mature.

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How big is REVLIMID revenue and what has driven its financial trajectory?

REVLIMID revenue has historically moved with a blend of regimen prevalence (multiple myeloma standard-of-care role), patient access economics (payer behavior and reimbursement), and supply reliability. The drug’s commercial pattern aligns with a mature oncology franchise: growth is incremental, while profitability is increasingly a function of net price and contracting discipline rather than unit expansion.

Revenue drivers: what moves the P&L

• Net price resilience vs. rebate intensity
  • Brand oncology drugs typically face accelerating rebate pressure as biosimilar and generic threats approach.
  • For REVLIMID, net revenue has generally tracked pricing pressure cycles through major contracting periods.
• Dose intensity and regimen mix
  • Lenalidomide’s economics depend on effective exposure. In practice, treatment duration and dose modifications driven by toxicity (notably hematologic events) influence total units.
• Regulatory and guideline-linked adoption
  • Indications across multiple myeloma lines support broad patient pools, but incremental adoption is tied to label expansion, comparative regimen evidence, and clinician preference.
• Supply and manufacturing continuity
  • Any supply disruption has outsized effect on revenues because oncologic therapy interruption is clinically consequential and forces treatment switching.

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What market dynamics shape demand for lenalidomide in multiple myeloma?

Lenalidomide demand is a function of patient population, regimen usage, and payer access mechanics. The key commercial dynamics are stable long-cycle prescribing in myeloma, ongoing regimen intensification, and careful contracting.

Core demand fundamentals

• Large, expanding myeloma patient base
  • Myeloma incidence and improved survival increase prevalent patient counts.
• Combinations sustain utilization
  • Lenalidomide typically functions as a backbone in combination regimens. Backbones often keep usage sticky even when other agents change.
• Real-world adherence and dose modification
  • Treatment interruptions reduce monthly units. Dose adjustments tied to safety management can compress or extend utilization.

Payer and reimbursement mechanics

• Formulary placement and prior authorization
  • Payers tend to manage access via step edits, prior authorization, and outcomes-based contracting.
• Net price compression
  • Rebate escalation is a predictable response to competitive threats and procurement leverage.

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When does REVLIMID lose exclusivity and what does that mean for market share?

Exclusivity loss affects not only launch timing but also net price. The market usually prices in generic risk before the formal “first generic ship” date via contracting behavior, rebate acceleration, and formulary actions.

Practical “exclusivity” concept in branded oncology economics

• Regulatory exclusivity (e.g., new chemical entity or other statutory data exclusivity)
  • Acts as a gate for direct substitution or approval pathways in the US.
• Patent exclusivity
  • The critical driver for generic entry because US FDA generic approval still depends on patent status and litigation outcomes for listed Orange Book patents.
• Settlement-driven entry timing
  • Many exclusivity and patent-life transitions in high-value generics result in delayed entry and structured launch windows.

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What patent estate protects REVLIMID and how strong is it against generics?

For lenalidomide, the brand’s protection has historically extended through a combination of composition, method-of-use, and formulation/manufacturing IP that can block or deter FDA approval and commercial launch.

IP pillars that typically block generic substitution

• Composition-of-matter patents
  • Protect core active ingredient claims and key structural forms.
• Method-of-use patents
  • Cover specific dosing schedules, treatment lines, and combination regimens.
• Formulation and manufacturing patents
  • Protect processes, particle size and stability-related parameters, or encapsulation/solid-state characteristics.

Market impact of patent strength

• Higher expected settlement likelihood
  • Strong patent estates reduce the probability of an immediate generic “at launch” scenario.
• Longer pricing protection windows
  • Even before generic approvals, payers often adjust their contracting stance once patent certainty declines.

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Which companies are challenging REVLIMID, and what is the Paragraph IV risk profile?

Generic entry threats typically come through Abbreviated New Drug Applications (ANDAs) with patent certifications under Paragraph IV. The commercial significance is twofold:

1. legal leverage toward settlements,
2. timing of manufacturing scale-up and wholesale channel replacement.

Commercial meaning of Paragraph IV outcomes

• If litigation favors brand
  • Generic approval and launch are blocked or delayed, and pricing may stabilize.
• If litigation favors generic
  • Brand revenue can step down rapidly in affected dosages and channels where switching is permissible.

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How does the Orange Book status of REVLIMID affect generic launch timing?

Orange Book listings control FDA generic approval sequencing and the certification triggers that lead to automatic stays and litigation timelines. The practical effect for business planning is that Orange Book patent lists create “decision points”:

• litigation conclusion,
• settlement effective date,
• launch and distribution ramp.

What matters most commercially

• Which patents are listed as “protecting the drug product” by dosage form
  • If patents differ by strength, market substitution can begin in only certain SKU subsets.
• Remaining claim life by patent family
  • Families with remaining method-of-use or manufacturing claims can delay commercialization even when composition claims expire.

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What financial exposure does REVLIMID face from generic entry scenarios?

The exposure is typically non-linear:

• No-entry scenario: brand remains dominant, with incremental net price declines driven by payer leverage rather than competition.
• Partial-entry scenario: generics launch in selected strengths or packaging configurations, driving mix shift, rebate pressure, and channel exclusivity loss.
• Full-entry scenario: broad substitution reduces brand unit share and compresses net price quickly, though some patients may remain on brand due to switching friction or tolerance.

Where losses show up first

• Wholesale channel netbacks and contracting
  • Contract renewals tend to re-price when generic supply is credible.
• Formulary access
  • Managed entry can move patients off brand early if payer incentives favor lower-cost alternatives.

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How do settlements between brand and generic companies change REVLIMID revenue?

Settlements often determine launch dates, market scope, and at-risk activity. The business effect is typically:

• delayed generic ramp,
• structured competitive boundaries,
• brand channel stabilization in the interstitial period.

Revenue pattern around settlement windows

• Pre-settlement: net price compression accelerates as brand anticipates entry.
• Post-settlement: a pause in further downside can occur until actual launch; when launch starts, net price can fall faster than unit volume due to rebate changes.

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What is REVLIMID’s competitive landscape versus newer myeloma regimens?

REVLIMID’s competitive set is not only other lenalidomide products. The economic head-to-head includes:

• other backbone therapies for myeloma,
• immune therapies and proteasome inhibitors that alter sequencing,
• monoclonals and combination strategies that may reduce lenalidomide duration for some cohorts.

How competition affects the REVLIMID franchise

• Sequencing shifts can cap duration
  • If evidence supports reduced reliance on lenalidomide for certain subgroups, unit demand can soften even without generic entry.
• Combination persistence supports baseline resilience
  • Where lenalidomide remains a foundational component, its displacement risk is lower than for drugs that are “add-ons.”

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How does REVLIMID compare with other multiple myeloma backbone drugs on market risk?

Business risk for myeloma backbones varies by:

• patent durability,
• generic susceptibility,
• guideline centrality,
• payer willingness to switch.

Comparison framework (economic risk, not clinical equivalence)

• Lenalidomide (REVLIMID)
  • High commercial scale, significant generic susceptibility over time, but historically supported by patent and contracting dynamics.
• Other agents
  • Some have stronger patent tails or different substitution constraints, which can reduce near-term net price erosion.

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What manufacturing and supply-chain factors influence REVLIMID’s financial performance?

Supply constraints create revenue volatility because oncology patients require continuity. For mature franchises:

• capacity expansions stabilize shipments,
• quality events or batch issues can force inventory drawdowns and lost sales.

Key supply-chain sensitivities

• Raw material and API production continuity
• Finished dose packaging and stability
• Regulatory quality systems and lot-release timing
• Distribution channel replenishment capacity

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How do international markets affect REVLIMID growth versus US risk?

US generic risk may be partially offset by:

• continued brand strength in countries with different patent fences,
• differing regulatory timelines,
• localized contracting structures.

What matters for global financial trajectory

• Local patent validity and enforcement
• Market access constraints and national tender systems
• Distribution model and wholesaler behavior

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What FDA pathway considerations matter for generic competition to REVLIMID?

Generic competition is governed by FDA approval requirements for ANDAs and the patent certification regime. For brand economics:

• FDA approval timing,
• litigation stay durations,
• and launch feasibility affect when net price starts to compress.

Key pathway-linked timing levers

• Patent certification type
  • Paragraph IV drives litigation timelines and potential stays.
• Court outcome cadence
  • Shortens or extends the window for market re-contracting.
• Manufacturing readiness
  • Even after approval, commercial launch requires reliable supply and channel acceptance.

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Key takeaways

• REVLIMID’s financial trajectory is primarily a net price and contracting story, with unit demand supported by backbone regimen persistence in multiple myeloma.
• Exclusivity loss and Orange Book patent status drive the generic timeline; the magnitude of revenue erosion depends on whether entry is partial (SKU-limited) or full (broad substitution).
• Paragraph IV challenges and litigation outcomes are the dominant “step-change” factors; settlements can delay entry and stabilize revenue in the interim.
• Competition from newer myeloma regimens affects length of treatment and mix, but historical market behavior indicates lenalidomide retains centrality unless guidelines materially reduce its backbone role.
• Supply continuity remains a revenue lever in oncology; manufacturing disruptions translate quickly into lost sales and channel distrust.

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FAQs

1. How quickly do REVLIMID revenues drop after first generic shipment?
   Demand often shifts in contracts first, so net revenue can compress faster than unit share as rebates and wholesale pricing re-price.

2. Do generic companies launch all REVLIMID strengths simultaneously?
   Not always. Patent and formulation coverage can create staged entry by strength, package type, and indication-specific claims.

3. What dosing adherence factors influence total lenalidomide units used per patient?
   Hematologic toxicity management, treatment interruptions, and dose reductions tied to safety protocols affect monthly utilization.

4. How does settlement structure typically affect payer contracting for REVLIMID?
   Settlements often lead payers to adjust rebate schedules and formulary posture only once launch is credible, creating a later but sharper step-down.

5. Is the main competitive threat a generic lenalidomide product or alternative myeloma backbones?
   Generic substitution is usually the primary near-term net price catalyst; regimen evolution is the primary medium-term demand mix risk.

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References

No sources were provided in the prompt, and no cited materials can be listed without verifiable records.

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