LENALIDOMIDE Drug Patent Profile

Which patents cover Lenalidomide, and when can generic versions of Lenalidomide launch?

Lenalidomide is a drug marketed by Amneal, Apotex, Arrow Intl, Biocon Pharma, Cipla, Deva Holding As, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Lupin Ltd, Mylan, Novugen, Qilu, Sun Pharm, Torrent, and Zydus Pharms. and is included in eighteen NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lenalidomide

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

Summary for LENALIDOMIDE

US Patents:	0
Applicants:	17
NDAs:	18
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	1,224
Drug Prices:	Drug price information for LENALIDOMIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LENALIDOMIDE
DailyMed Link:	LENALIDOMIDE at DailyMed

See drug prices for LENALIDOMIDE

Recent Clinical Trials for LENALIDOMIDE

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
UNC Lineberger Comprehensive Cancer Center	PHASE2
Dickran Kazandjian, MD	PHASE2

See all LENALIDOMIDE clinical trials

Pharmacology for LENALIDOMIDE

Drug Class

Thalidomide Analog

Anatomical Therapeutic Chemical (ATC) Classes for LENALIDOMIDE

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LENALIDOMIDE

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 LENALIDOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	213912-004	Aug 30, 2022	AB	RX	No	No
Dr Reddys	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	209348-002	Oct 14, 2021	AB	RX	No	No
Deva Holding As	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	217554-002	May 22, 2025	AB	RX	No	No
Sun Pharm	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	211846-001	Feb 8, 2023	AB	RX	No	No
Hetero Labs Ltd V	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	212414-001	May 11, 2023	AB	RX	No	No
Lotus Pharm Co Ltd	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210480-004	Aug 31, 2022	AB	RX	No	No
Eugia Pharma	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	213885-003	Mar 6, 2023	AB	RX	No	No

EU/EMA Drug Approvals for LENALIDOMIDE

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
Krka, d.d., Novo mesto	Lenalidomide Krka d.d.	lenalidomide	EMEA/H/C/005729Multiple myelomaLenalidomide Krka d.d. 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 d.d. 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 d.d. 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 d.d. 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.Follicular lymphomaLenalidomide Krka d.d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Withdrawn	yes	no	no	2021-02-11
Krka, d.d., Novo mesto	Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)	lenalidomide	EMEA/H/C/005734Multiple myelomaLenalidomide krka d.d. Novo mesto 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 d.d. Novo mesto 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 d.d. Novo mesto 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 krka d.d. Novo mesto 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 d.d. Novo mesto 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 d.d. Novo mesto 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 d.d. Novo mesto 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 krka d.d. Novo mesto 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

Market Dynamics and Financial Trajectory for Lenalidomide

Last updated: October 20, 2025

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Introduction

Lenalidomide, marketed primarily under the brand name Revlimid, epitomizes a transformative oral immunomodulatory drug in the treatment of hematologic malignancies. Since its FDA approval in 2005, lenalidomide's market landscape has rapidly evolved, reflecting advancements in oncology therapeutics, regulatory pathways, and market demand trajectories. Analyzing its market dynamics and financial trajectory offers valuable insights for stakeholders navigating this complex pharmaceutical domain.

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Market Landscape and Therapeutic Applications

Lenalidomide’s initial indication was for multiple myeloma (MM), a plasma cell malignancy with historically limited treatment options. Over time, it received approvals for myelodysplastic syndromes (MDS) with del(5q), mantle cell lymphoma (MCL), and specific other hematologic conditions (FDA, 2015, 2019). Its broadening therapeutic scope has catalyzed consistent revenue growth.

The rising global incidence of hematological cancers, driven by aging populations and improved diagnostics, underscored increased demand. Globally, multiple myeloma alone accounts for approximately 1.8% of new cancer cases each year[1], underpinning a significant market opportunity.

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Market Drivers

1. Expanding Indications and Line Extensions

Lenalidomide’s primary revenue driver stems from its efficacy in relapsed/refractory multiple myeloma (RRMM). Often used in combination with dexamethasone or other agents, its efficacy profile solidifies its routine use in treatment algorithms. Regulatory enhancements include pivotal approvals for first-line MM therapy (e.g., in Europe and the US), further fueling growth.

2. Competitive Landscape and Patent Dynamics

While lenalidomide held a dominant market share, patent expirations, notably in the US in 2026, poised generic competition to diminish pricing power. The impending off-patent landscape has triggered strategic moves by originators to extend exclusivity, including patent litigation and formulation innovations[2].

3. Pricing Strategies and Reimbursement Policies

Premium drug positioning, coupled with high treatment costs (~$200,000 annually in the US), magnifies revenue. Payers scrutinize cost-effectiveness; however, robust clinical data cements lenalidomide's cost-benefit profile. Variations in reimbursement policies across geographies influence market penetration and profitability.

4. Manufacturing and Supply Chain Considerations

Consistent manufacturing quality and supply stability influence market confidence. Supply chain disruptions, observed during COVID-19, exposed vulnerabilities, prompting investments in capacity expansion and risk mitigation strategies[3].

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Market Challenges

1. Biosimilar and Generic Competition

Post-patent expiry, biosimilars like Apotex’s Ameluzim and others are anticipated to erode market share, intensifying price competition[4]. Leading pharmaceutical companies are pre-emptively developing next-generation formulations or combination therapies to retain market relevance.

2. Regulatory and Legal Risks

Legal battles over patent rights and regulatory approvals remain prevalent. Disputes delaying biosimilar market entry can temporarily sustain revenue streams, but long-term impacts depend on litigation outcomes.

3. Evolving Treatment Paradigms

Emerging therapies, including CAR-T cell treatments and monoclonal antibodies (e.g., daratumumab), threaten to supplant lenalidomide as standard care in certain settings. The competitive landscape mandates continual positioning of lenalidomide within evolving treatment algorithms.

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Financial Trajectory and Revenue Forecast

Historical Revenue Trends:

Revlimid’s revenue peaked around 2018–2019 at approximately $10.3 billion globally[5]. Its dominant position in multiple myeloma therapy, combined with continued approval for additional indications, sustained high margins.

Impact of Patent Expiry:

Projected patent cliffs by 2026 in the U.S. will precipitate significant revenue erosion. According to IQVIA estimates, biosimilar entry could reduce Revlimid sales by approximately 40-60% over subsequent 3–5 years[6].

Emerging Revenue Streams:

Companies have invested in next-generation formulations (e.g., oral formulations with improved pharmacokinetics). Additionally, downstream licensing and collaborations with biotech firms targeting combination regimens augment revenue prospects.

Forecast Models:

Market analysts project a compound annual growth rate (CAGR) of approximately 2–4% for lenalidomide from 2023 through 2030, factoring in generic competition and pipeline developments[7]. The initial post-patent period is expected to witness sharp declines, but strategic diversification and pipeline expansion could stabilize long-term revenues.

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Opportunities and Strategic Outlook

1. Diversification of Indications

Expanding into autoimmune diseases and solid tumors is under exploration, potentially offsetting declines in hematologic contexts.

2. Innovation in Formulation and Delivery

Enhanced formulations, such as sustained-release versions, could command premium pricing and extend market exclusivity.

3. Collaboration and Licensing

Partnerships with biotech firms exploring novel immunomodulatory mechanisms may bolster the drug portfolio.

4. Geographic Expansion

Emerging markets hold substantial growth opportunities, where increasing healthcare access and rising cancer prevalence provide fertile ground.

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Regulatory and Ethical Considerations

Regulatory agencies prioritize biosimilar approval pathways, balancing cost savings against safety and efficacy concerns. The industry must navigate complex patent landscapes, antitrust regulations, and ethical issues surrounding high-cost therapies.

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Conclusion

Lenalidomide's market dynamics reflect a mature yet rapidly evolving therapeutic landscape. Its initial success was driven by robust clinical efficacy and strategic patent protections. As patent protection diminishes, the trajectory hinges on biosimilar competition, pipeline innovation, and diversification strategies.

Investment opportunities lie in innovation-driven formulations, expanding indications, and geographic market penetration. Conversely, stakeholders must contend with patent expiries and rising competition by fostering strategic collaborations and pipeline development.

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Key Takeaways

• Market growth historically close to double digits propelled by multiple indications, but patent expirations forecast significant revenue declines absent strategic adaptations.
• Generics and biosimilars will compress market share and pricing power post-2026, necessitating innovation and pipeline expansion.
• Expansion into new indications and regions offers commercialization opportunities but requires rigorous clinical validation and regulatory navigation.
• A robust supply chain, proactive patent management, and strategic alliances are critical to sustain profitability amid intensifying competition.
• Continuous monitoring of treatment paradigm shifts is critical, as emerging therapies may redefine standard-of-care, impacting lenalidomide's market position.

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References

[1] International Agency for Research on Cancer. "Global Cancer Statistics 2020."
[2] Johnson & Johnson. Patent filings and legal strategies information, 2023.
[3] COVID-19 Supply Chain Impact Report, 2022.
[4] IQVIA. Biosimilar Market Outlook, 2022.
[5] EvaluatePharma. "Top Pharma Sales of 2019," 2020.
[6] IQVIA. Post-Patent Market Forecasts, 2022.
[7] GlobalData. Hematologic Cancer Market Projections, 2023.