LENALIDOMIDE - Generic Drug Details

What are the generic sources for lenalidomide and what is the scope of freedom to operate?

Lenalidomide is the generic ingredient in two branded drugs marketed by Apotex, Arrow Intl, Cipla, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Mylan, Novugen, Qilu, Sun Pharm, Torrent, Zydus Pharms, and Bristol Myers Squibb, and is included in fifteen NDAs. There are three 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. Thirteen suppliers are listed for this compound.

Summary for LENALIDOMIDE

International Patents:	331
US Patents:	3
Tradenames:	2
Applicants:	14
NDAs:	15
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	1,131
Patent Applications:	6,850
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
Canadian Institutes of Health Research (CIHR)	Phase 3
Canadian Cancer Trials Group	Phase 3
Myeloma Canada	Phase 3

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
Cipla	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210435-002	Sep 6, 2022	AB	RX	No	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No	7,465,800		Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005	AB	RX	Yes	No
Zydus Pharms	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210154-001	Sep 12, 2022	AB	RX	No	No
Sun Pharm	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	211846-006	Mar 6, 2023	AB	RX	No	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	021880-004	Jun 29, 2006	6,561,977
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	7,968,569
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	6,045,501
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	6,561,976
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	8,404,717

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/005306 Multiple 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/004857 Multiple 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/000717 Multiple 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/005348 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).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/005729 Multiple 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
China	101583359	Use of 3- (4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment of mantle cell lymphomas
Russian Federation	2406501	СПОСОБЫ ПРИМЕНЕНИЯ 3-(4-АМИНО-1-ОКСО-1, 3-ДИГИДРОИЗОИНДОЛ-2-ИЛ)ПИПЕРИДИН-2, 6-ДИОНА ДЛЯ ЛЕЧЕНИЯ ОПРЕДЕЛЕННЫХ ТИПОВ ЛЕЙКОЗА (METHODS FOR ADMINISTRATION OF 3-(4-AMINO-1-OXO-1,3-DIHYDROISOINDOLE-2-YL)PIPERIDINE-2,6-DIONE IN CERTAIN TYPES OF LEUKEMIA)
Israel	207458	צורות פולימורפיות של 3-(4-אמינו-1-אוקסו-3,1 דיהידרו-איסואינדול-2-איל)-פיפרידינ-6,2-דיון (Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione)
Cyprus	1115782
New Zealand	540385	Use of 1-oxo-2-(2, 6-dioxopiperidin-3-yl)-4-methylisoindoline in the manufacture of a medicamnent for treatment of brain cancer

Supplementary Protection Certificates for LENALIDOMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	C300717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
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
2105135	C20150005 00140	Estonia		PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
2105135	122015000013	Germany		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805

LENALIDOMIDE Market Analysis and Financial Projection Experimental

Lenalidomide Market Dynamics and Financial Trajectory

Market Overview

Lenalidomide, a drug primarily used to treat multiple myeloma and other blood cancers, has seen significant growth in recent years. Here’s a detailed look at the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth

The lenalidomide market has been expanding rapidly. In 2023, the market size was valued at approximately $11.05 billion and is expected to grow to $11.91 billion in 2024, with a compound annual growth rate (CAGR) of 7.8%[1].

By 2028, the market is projected to reach $16.29 billion, driven by a CAGR of 8.2%[1]. Another forecast indicates that the market will grow from $10.86 billion in 2024 to $15.67 billion by 2032, with a CAGR of 4.7%[2].

Key Drivers of Growth

Several factors are driving the growth of the lenalidomide market:

Increasing Prevalence of Blood Cancers

The rising prevalence of multiple myeloma and other blood cancers is a significant driver. For instance, in the United States, about 34,920 new cases of multiple myeloma were diagnosed in 2021, and 12,410 deaths were reported due to the disease[4].

Regulatory Approvals and Expanded Indications

Increased regulatory approvals for expanded indications are boosting the market. Lenalidomide is now approved for various cancer treatments beyond multiple myeloma, which is expanding its market reach[1].

Advancements in Clinical Research

Ongoing research and development activities aimed at improving the efficacy and delivery systems of lenalidomide are supporting market growth. New formulations and novel drug delivery systems are expected to enhance treatment outcomes[3].

Strategic Partnerships and Emerging Markets

Strategic partnerships among pharmaceutical companies and the increasing adoption of lenalidomide in emerging markets are also contributing to the market's expansion[1].

Market Segments

Application Segments

The multiple myeloma segment accounted for the largest market share in 2023 and is expected to maintain its dominance throughout the forecast period. Lenalidomide's superior performance in treating multiple myeloma is a key factor in this segment's growth[2].

End-User Segments

The hospital segment holds a significant market share due to the increasing number of cancer patients seeking treatment in these facilities. The rising awareness about blood cancers is driving more patients to seek medical consultations, thereby boosting demand for lenalidomide in hospitals[2].

Dosage Forms

The capsule segment has witnessed a dominant share in the global market, reflecting the preferred mode of administration for lenalidomide[2].

Geographic Distribution

North America

North America, particularly the United States, dominates the lenalidomide market. The higher prevalence of multiple myeloma and myelodysplastic syndromes, along with greater awareness and demand for better treatment options, are key factors driving growth in this region[4].

Financial Trajectory

Revenue and Profit Margins

Celgene, the original developer of lenalidomide (marketed as Revlimid), reported over $51 billion in net worldwide revenue from the drug from 2009 to 2018. The U.S. market accounted for $32 billion of this total, with revenue increasing from $1 billion in 2009 to nearly $6.5 billion in 2018[5].

Pricing Strategies

The pricing of lenalidomide has been a significant factor in its financial trajectory. For example, after Bristol Myers Squibb acquired Celgene, the price of Revlimid was raised again, reaching $763 per pill. Pricing decisions have been driven by revenue and earnings goals, with frequent price increases contributing to substantial profits[5].

Impact of Generic Versions

The patent expiry of lenalidomide and the subsequent entry of generic versions are expected to impact the market. While generics may reduce the market share of branded versions, they will also make the treatment more accessible and cost-effective, potentially sustaining overall market growth[3].

Challenges and Opportunities

COVID-19 Impact

The COVID-19 pandemic had a temporary impact on the lenalidomide market due to delays in diagnosis and treatment of multiple myeloma. However, as normalcy returns, the market is expected to recover and continue its growth trajectory[4].

Regulatory Advancements

Regulatory advancements and evolving healthcare policies favoring cost-effective treatment options are shaping the market dynamics. The growing emphasis on real-world evidence in treatment decisions and the expanded applications of lenalidomide beyond hematological malignancies present opportunities for further growth[1].

Key Players

Major players in the lenalidomide market include Celgene (now part of Bristol Myers Squibb), Celltrion, Dexa Medical, and LEO Pharma. These companies are investing heavily in research and development and forming strategic partnerships to maintain their market positions[2].

Future Outlook

The lenalidomide market is poised for continued growth driven by increasing demand for targeted therapies, emerging market adoption, and advancements in clinical research. Here are some key trends to watch:

• Increased Adoption in Emerging Markets: Growing healthcare infrastructure and increasing awareness in emerging markets are expected to drive adoption.
• Focus on Combination Therapies: Shifting treatment paradigms towards combination therapies will further boost the demand for lenalidomide.
• Personalized Medicine Approaches: The rising demand for personalized medicine approaches will influence the market dynamics.
• Evolving Pricing Strategies: Changes in pricing strategies due to the entry of generic versions and regulatory pressures will shape market competitiveness[1].

"Lenalidomide is used to treat people suffering from low blood cells. The rising number of anemic people in the world is expected to fuel its demand"[2].

Key Takeaways

• The lenalidomide market is expected to grow significantly, driven by increasing prevalence of blood cancers and regulatory approvals for expanded indications.
• North America, particularly the United States, dominates the market due to higher disease prevalence and greater awareness.
• The hospital segment and capsule dosage form are significant contributors to the market.
• Pricing strategies and the entry of generic versions will impact the market's financial trajectory.
• Ongoing research and development, along with emerging market adoption, will sustain market growth.

FAQs

Q: What is the current market size of lenalidomide?

The lenalidomide market size was valued at approximately $11.05 billion in 2023 and is expected to grow to $11.91 billion in 2024[1].

Q: What are the key drivers of the lenalidomide market growth?

Key drivers include the increasing prevalence of blood cancers, regulatory approvals for expanded indications, advancements in clinical research, and strategic partnerships[1][3].

Q: Which segment holds the largest market share in the lenalidomide market?

The multiple myeloma segment accounted for the largest market share in 2023 and is expected to maintain its dominance throughout the forecast period[2].

Q: How has the COVID-19 pandemic impacted the lenalidomide market?

The COVID-19 pandemic caused a temporary decline due to delays in diagnosis and treatment of multiple myeloma, but the market is expected to recover as normalcy returns[4].

Q: What are the major trends expected to shape the lenalidomide market in the future?

Major trends include increased adoption in emerging markets, a heightened focus on combination therapies, rising demand for personalized medicine approaches, and evolving pricing strategies[1].