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
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	021880-004	Jun 29, 2006
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011

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
Portugal	1487461
Hong Kong	1148274
Japan	5244268
Slovenia	1667682
Spain	2718927

Supplementary Protection Certificates for REVLIMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	5/2015	Austria		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	1590004-6	Sweden		PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
0925294	91359	Luxembourg		91359, EXPIRES: 20220614
2105135	212 50002-2015	Slovakia		PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135	C300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805

Market Dynamics and Financial Trajectory of REVLIMID

Last updated: February 19, 2026

What Are the Key Market Players and Sales Trends for REVLIMID?

REVLIMID (lenalidomide), manufactured by Celgene (acquired by Bristol-Myers Squibb in 2019), dominates the global multiple myeloma therapeutic market. As of 2022, it reports annual sales exceeding $10 billion. The drug's sales are driven by its approved indications for multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma, with expansion into earlier lines of treatment expanding its market.

Key competitors include Takeda's Ninlaro (ixazomib), Johnson & Johnson’s Darzalex (daratumumab), and multiple generic versions of lenalidomide in markets where patents have expired or are nearing patent expiry.

Sales growth has been consistent, with an average compound annual growth rate (CAGR) of approximately 4.5% from 2018 to 2022, boosted by expanding indications and geographic penetration, especially in Asia-Pacific and emerging markets.

How Have Patent and Patent Expiry Impacts Shaped Its Market?

Patent protection for REVLIMID in the United States and Europe originally extended until 2027. Patent expiration in certain jurisdictions has introduced generics and biosimilars, leading to price erosion.

In the U.S., the first generic lenalidomide emerged in late 2021, reducing the drug's price landscape. Despite this, branded REVLIMID retains a significant market share due to brand loyalty, approved label extensions for new indications, and extensive clinical data.

Patent challenges continue, with ongoing litigation in various regions aiming to extend exclusivity or invalidate generic patents. These legal battles influence long-term sales projections.

What Are the Regulatory and Geographical Expansion Trends?

REVLIMID has secured regulatory approvals for multiple indications, including multiple myeloma (initial approval in 2005), myelodysplastic syndromes (2006), and mantle cell lymphoma (2013). Its label has expanded post-approval, covering combinations with other agents, such as dexamethasone, bortezomib, and monoclonal antibodies.

Geographically, the U.S. accounts for over 50% of sales. Europe follows, with China representing a rapidly growing market due to increased local oncology diagnoses and improved healthcare infrastructure. Market entry in Japan and South Korea has also contributed to revenue growth through licensing agreements.

What Are the Future Revenue Drivers and Risks?

Potential future revenue streams include:

• New indications: Cell therapy combination regimens and early-line treatment.
• Expanded access: Through regulatory approvals in underserved regions.
• Line extension and formulations: Extended-release versions or subcutaneous options to improve compliance.

Risks involve:

• Patent challenges: Eroding exclusivity.
• Pricing pressures: From payers and governments aiming for generic price reductions.
• Competitive landscape: Introduction of novel therapies, including CAR-T cell therapies and bispecific antibodies, may threaten market share.

How Does REVLIMID Fit into the Broader Oncology Market?

REVLIMID operates within a competitive, rapidly evolving oncology landscape. Its success stems from a well-established efficacy profile, multiple-line approvals, and combination use. As the oncology pipeline introduces innovative therapies, REVLIMID's market share may face pressures, especially if competing agents demonstrate superior efficacy and safety profiles.

Financial Projections and Investment Outlook

Analysts project that REVLIMID's global sales will gradually decline post-2027 due to patent expiry and generic competition but will remain substantial through 2030 owing to established indications and ongoing label expansions. Bristol-Myers Squibb estimates revenues from REVLIMID to stay above $7 billion annually through 2025, with a potential decline to below $4 billion by 2030 if generics fully penetrate core markets.

Investors should consider the impact of patent challenges, upcoming biosimilar entries, and pipeline assets when evaluating long-term value.

Key Takeaways

• REVLIMID’s sales exceeded $10 billion in 2022, driven by multiple myeloma and expanding indications.
• Patent expiry and generic entry in the U.S. (2021) and Europe threaten to significantly erode revenue.
• Growth depends on regulatory approvals, geographic expansion, and label extensions.
• The competitive landscape grows fiercer with new therapies like CAR-T, bispecifics, and novel oral agents.
• Revenue is expected to decline post-2027 but remain significant through the early 2030s.

FAQs

1. When will generic lenalidomide impact REVLIMID sales most significantly?
Patent expirations in the U.S. and Europe around 2027-2028 are likely to cause a substantial decline in branded sales starting from late 2021, with generics gaining broader market share by 2027.

2. How does the approval of new indications influence REVLIMID’s revenue?
Label extensions for new indications and combination regimens can prolong sales by expanding patient populations and maintaining market relevance.

3. What are the primary risks related to REVLIMID’s future profitability?
Patent litigation, drug price controls, competition from novel therapies, and biosimilar entries remain primary risks.

4. Which markets are growing fastest for REVLIMID?
China, India, and Southeast Asia are experiencing rapid growth due to increased healthcare infrastructure and cancer diagnosis rates.

5. How does the pipeline influence the outlook for REVLIMID?
While the pipeline offers potential for lifecycle extension through combination therapies or new indications, competition from emerging therapies may limit long-term sales.

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References

[1] EvaluatePharma. (2023). Global oncology drug sales data.
[2] Bristol-Myers Squibb. (2022). Annual report.
[3] U.S. Food and Drug Administration. (2022). REVLIMID approval and patent status.
[4] European Medicines Agency. (2022). Regulatory documents for REVLIMID.
[5] IMS Health. (2022). Market analysis of multiple myeloma therapies.