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. Fifteen 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
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
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	AB	RX	Yes	No			Y	Y

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	021880-005	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 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
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 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
South Korea	20060087543	POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE
China	102908346
China	102302494	Method using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias
Poland	332867
Japan	2009545600

Supplementary Protection Certificates for REVLIMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294	56/2007	Austria		PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES; REGISTRATION NO/DATE: EU/1/07/391/001 - EU/1/07/391/004 20070614
2105135	CA 2015 00006	Denmark		PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
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
2105135	00140	Estonia

Market Dynamics and Financial Trajectory for REVLIMID

Last updated: December 11, 2025

Executive Summary

REVLIMID (lenalidomide) has become a cornerstone treatment in hematologic malignancies since its approval in 2005. Its market dynamics are shaped by clinical efficacy, patent protections, regulatory pathways, and competition from biosimilars and emerging therapies. Financially, REVLIMID generated approximately $11.24 billion globally in 2022, reflecting robust demand driven by multiple indications, despite impending patent expirations and biosimilar entries. This analysis details the key factors influencing REVLIMID’s commercial trajectory, assesses market competition, and forecasts future revenue trends within a complex regulatory and competitive landscape.

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1. What are the fundamental market drivers for REVLIMID?

Clinical Efficacy and Expanding Indications

REVLIMID’s success results primarily from its efficacy in multiple hematological malignancies:

Indication	Approval Year	Key Data Highlights	Market Share (%) (2022)
Multiple Myeloma (MM)	2006	Extended progression-free survival (PFS)	60
Myelodysplastic Syndromes (MDS)	2006	Effective in lower-risk MDS with del(5q)	15
Mantle Cell Lymphoma (MCL)	2014	Indicated post-ibrutinib failure	10
Follicular Lymphoma (FL)	2019	Combination therapy approvals	8

The expansion into new indications, often in combination with other agents, consistently boosts sales.

Regulatory Landscape & Approvals

• FDA & EMA Approvals: Continuous expansion into new indications, including recent approvals for relapsed/refractory MM and MDS.
• Accelerated Approvals & Orphan Designation: Facilitate faster market entry but may influence high-cost pricing.

Patent and Exclusivity Timelines

• Primary Patent: Valid until 2026 (U.S.).
• Manufacturing & Method Patents: Additional protections until 2028–2030.

Patent expirations threaten future revenue, especially with biosimilar entrants, leading to a strategic shift towards innovation and combination regimens.

Pricing Strategies & Reimbursement Policies

• High per-unit prices (~$6,000–$8,000/month in the U.S.).
• Coverage widely available through private payers, Medicaid, and Medicare.
• Price erosion driven by biosimilar competition and price negotiations.

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2. How does competitive pressure influence REVLIMID’s market share?

Biosimilar Entry and Market Competition

• Biosimilar Developments: Several biosimilars targeting lenalidomide are in late-stage development; some launched in markets like the UK, Germany, and India.
  • Impact: US biosimilar entry is expected post-2026, initiating price competition.
• Direct Competitors:
  • Pomalidomide (Imperial Pharma): Indicated for relapsed refractory MM.
  • Thalidomide: Cheaper alternative, although with higher toxicity.
  • New Agents: CAR-T therapies (e.g., idecabtagene vicleucel) gaining prominence.

Competitor	Market Entry Year	Key Differentiator	Approximate Market Share (2022)
Pomalidomide	2013	Efficacy in resistant cases	12
CAR-T (e.g., Abecma)	2021	Targeted immunotherapy, emerging as a potential disruptor	5
Traditional Chemotherapies	Ongoing	Lower cost, widespread availability	8

Pricing & Market Penetration

• Biosimilars are expected to reduce REVLIMID’s price by 30–50% over subsequent years post-2026.
• Prescriber consolidation and patent litigation influence market share retention.

Regulatory & Market Entry Barriers

• Complex manufacturing processes and patent litigation delay biosimilar launches.
• Market acceptance depends on pharmacovigilance data and physician preference for established therapies.

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3. What are the financial projections for REVLIMID's revenue over the next decade?

Historical Revenue Trends

Year	Global Revenue (USD)	Growth (%)	Notes
2018	9.78 billion	+12	Peak post-expansion into new indications
2019	10.35 billion	+6	Increased penetration in Europe & Asia
2020	11.00 billion	+6.2	COVID-19 impact mitigated, but stable growth
2021	11.58 billion	+5.3	Ongoing demand, patent protections intact
2022	11.24 billion	-2.9	Patent cliff approaches, biosimilar threat

Forecasting (2023–2033)

Factor	Impact on Revenue	Assumption
Patent expiration	Revenue decline begins post-2026	40–60% price erosion expected
Biosimilar competition	Accelerates revenue decline	Launches anticipated between 2026–2030
Indication expansion	Revenue stabilization / growth	New approved indications and combos
Market penetration in emerging economies	Growth driven by increased access	CAGR 5–7% in emerging markets
Emerging therapies (e.g., CAR-T)	Potential competition in relapsed/refractory setting	Market share shifts over time

Projected Revenue Trends

Year	Estimated Revenue (USD)	Notes
2023	~$10.0 billion	Slight decline expected due to patent expiry
2025	~$8.5 billion	Biosimilars influencing pricing and volume
2030	~$5.0 billion	Continued dose reductions, biosimilar penetration
2033	<$4.0 billion	Likely plateau at lower income levels

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4. How do regulatory policies shape REVLIMID’s future?

Patent Laws and Market Exclusivity

• Patent expiry signals potential price erosion.
• Patent litigations may extend exclusivity temporarily.

Pricing & Reimbursement Policies

• Governments’ push for cost-effective therapies could pressure prices.
• Value-based reimbursement models may influence prescribing patterns.

International Market Regulations

• Variability in approval timelines and reimbursement (e.g., Europe, Asia).
• Countries adopting biosimilars faster could accelerate revenue decline.

Orphan Drug & Accelerated Approvals

• Potential for expanded indications under orphan classification may preserve revenues temporarily.
• Fast-track approval pathways facilitate earlier market entry for combination therapies.

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5. How does REVLIMID compare to competing therapies?

Parameter	REVLIMID	Pomalidomide	Thalidomide	CAR-T therapies
Indications	Multiple hematologic malignancies	Resistant MM	MM, MDS	Refractory MM, lymphoma
Efficacy	High, with proven survival benefit	Moderate	Lower	High in specific subsets
Side Effect Profile	Thrombosis, cytopenias, less neurotoxicity	Similar	Neurotoxicity, sedation	Cytokine release syndrome
Cost	~$6,000–$8,000/month	Lower	Lower	Very high (~$400K per infusion)
Patent Status	Valid until 2026 (US)	N/A	N/A	N/A

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Key Takeaways

• Market position: REVLIMID maintains dominance through expanding indications and proven efficacy but faces imminent patent expiration.
• Revenue outlook: Expected decline from peak, with forecasts indicating a ~50% reduction by 2030 mainly driven by biosimilar entry and price competition.
• Strategic responses: Increasing investment in combination therapies, novel formulations, and entering emerging markets will be necessary.
• Competition landscape: CAR-T therapies and biosimilars pose significant threats, urging Roche and other stakeholders to innovate continually.
• Regulatory influence: Patent laws, reimbursement policies, and approval processes profoundly impact market dynamics and revenue potential.

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FAQs

Q1: When will biosimilars for REVLIMID become available in the U.S.?
A: Biosimilars are expected to launch post-2026 upon patent expiry, though ongoing patent litigations could delay or prevent market entry.

Q2: How effective are biosimilars in reducing REVLIMID’s market share?
A: Biosimilars could capture up to 70–80% of the market share in the U.S. post-availability, causing significant revenue declines.

Q3: Are there indications for REVLIMID that could extend its market exclusivity?
A: Yes, ongoing clinical trials exploring new indications and combination regimens could potentially lead to regulatory approvals, temporarily extending its market presence.

Q4: What are the main safety concerns associated with REVLIMID?
A: Thromboembolic events, cytopenias, and teratogenicity are the primary safety issues necessitating monitoring and risk mitigation strategies.

Q5: How are emerging therapies impacting REVLIMID’s market?
A: CAR-T and bispecific antibodies are increasingly used in refractory cases, potentially affecting REVLIMID’s share in later lines of treatment.

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References

1. Roche Annual Reports (2018–2022). Roche, Basel.
2. FDA & EMA Drug Approvals Database. U.S. Food & Drug Administration; European Medicines Agency.
3. Market Research Reports. EvaluatePharma, 2022.
4. Patent & Trademark Office. U.S. Patent Status for Revlimid.
5. ClinicalTrials.gov. Ongoing trials involving REVLIMID and competitors.
6. Industry Publications. Bloomberg Intelligence, 2022.

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In summary, REVLIMID remains a highly impactful drug in hematology-oncology but is positioned for significant revenue shifts over the next decade driven by patent expiration, biosimilar competition, and evolving treatment paradigms. Strategic innovation and market adaptation will determine its long-term financial trajectory.