Lenalidomide - Generic Drug Details

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

Lenalidomide is the generic ingredient in two branded drugs 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, Zydus Pharms, and Bristol Myers Squibb, and is included in nineteen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are fourteen drug master file entries for lenalidomide. Fifteen suppliers are listed for this compound.

Summary for lenalidomide

International Patents:	331
US Patents:	2
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	1,224
Patent Applications:	6,493
Drug Prices:	Drug price trends for lenalidomide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lenalidomide
What excipients (inactive ingredients) are in lenalidomide?	lenalidomide excipients list
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
Regeneron Pharmaceuticals	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
Lupin Ltd	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	214398-002	Sep 16, 2025	AB	RX	No	No
Lotus Pharm Co Ltd	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210480-006	Mar 6, 2023	AB	RX	No	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	AB	RX	Yes	Yes
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	AB	RX	Yes	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	AB	RX	Yes	No

Expired US Patents for lenalidomide

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	021880-005	Dec 21, 2011
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006

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

International Patents for lenalidomide

Country	Patent Number	Title	Estimated Expiration
Mexico	PA05012155	METODOS Y COMPOSICIONES QUE UTILIZAN COMPUESTOS INMUNOMODULADORES PARA EL TRATAMIENTO Y MANEJO DE CANCERES Y OTRAS ENFERMEDADES. (METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES.)
Canada	2688709	FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE)
Taiwan	I492746
Poland	2046331
Costa Rica	8291	FORMAS POLIMORFICAS 3-(4-AMINO-1-OXO-1,3 DIHIDRO -ISOINDOL-2-IL)-PIPERIDIN-2, 6-DIONA

Supplementary Protection Certificates for lenalidomide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	212 50002-2015	Slovakia		PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
0925294	07C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
2105135	00140	Estonia
2105135	C20150005 00140	Estonia		PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013

Market Dynamics and Financial Trajectory for Lenalidomide

Last updated: October 20, 2025

---

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.

---

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.

---

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].

---

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.

---

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.

---

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.

---

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.

---

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.

---

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.

---

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.