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Last Updated: December 23, 2024

REVLIMID Drug Patent Profile


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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 three 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. Thirteen 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 21st, 2021.

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Drug patent expirations by year for REVLIMID
Drug Prices for REVLIMID

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Recent Clinical Trials for REVLIMID

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

SponsorPhase
City of Hope Medical CenterPhase 2
Regeneron PharmaceuticalsPhase 3
Wuhan Union Hospital, ChinaPhase 2

See all REVLIMID clinical trials

Pharmacology for REVLIMID
Drug ClassThalidomide 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 three US patents and three 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 021880-004 Jun 29, 2006 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 8,492,406 ⤷  Subscribe
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 8,315,886 ⤷  Subscribe
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 8,589,188 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for REVLIMID

See the table below for patents covering REVLIMID around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1092388 ⤷  Subscribe
Serbia 20120340 POLIMORFNI OBLICI 3-4(4-AMINO-1-OKSO-1, 3-DIHIDRO-IZOINDOL-2-IL)-PIPERIDIN-2, 6-DIONA (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,9-DIONE) ⤷  Subscribe
China 1822834 Methods and compositions using immunomodulatory compounds for treatment and management of cancers and other diseases ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REVLIMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294 SZ 56/2007 Austria ⤷  Subscribe 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
2105135 212 50002-2015 Slovakia ⤷  Subscribe PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135 122015000013 Germany ⤷  Subscribe PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

REVLIMID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Revlimid

Introduction to Revlimid

Revlimid, a drug developed by Celgene and now owned by Bristol Myers Squibb (BMS), is a cornerstone in the treatment of multiple myeloma and other hematological cancers. Its market dynamics and financial trajectory are influenced by several key factors, including generic competition, pricing strategies, and the broader pharmaceutical market landscape.

Historical Revenue Performance

From 2009 to 2018, Revlimid generated over $51 billion in net worldwide revenue, with the U.S. market accounting for $32 billion of this total. During this period, Celgene's net U.S. revenue from Revlimid increased dramatically, from $1 billion in 2009 to nearly $6.5 billion in 2018[3].

Impact of Generic Competition

The introduction of generic versions of Revlimid has significantly impacted its revenue. In 2022, sales of Revlimid dropped below expectations, with $2.8 billion in the first quarter, a decline from $2.9 billion in the same period the previous year. This decline was particularly pronounced internationally, where generic competition led to a 23% drop in sales outside the U.S.[2].

Current Market Size and Projections

As of 2023, the global Revlimid market was valued at approximately $8 billion. However, forecasts indicate a mixed outlook:

  • One report suggests the market will decline to $6.006 billion by 2030, with a CAGR of -5.2% from 2024 to 2030[1].
  • Another report predicts the market will grow to $11.8 billion by 2031, with a CAGR of 5% from 2024 to 2031, driven by its efficacy in treating multiple myeloma and other lymphomas, as well as expanding indications and strategic partnerships[4].

Regional Performance

The impact of generic competition varies by region. In the U.S., while generics entered the market later than expected, they are anticipated to erode Revlimid's sales more significantly in the second half of the year. Internationally, particularly in Europe, generic competition has already led to substantial revenue declines[2].

Pricing Strategies and Revenue Impact

Historically, Celgene and BMS have employed aggressive pricing strategies to maximize revenue from Revlimid. For instance, Celgene orchestrated emergency price increases to meet quarterly revenue targets. However, these strategies are now being challenged by the advent of generics, which offer cheaper alternatives and are eroding Revlimid's market share[3].

Quarterly and Annual Revenue Trends

In recent quarters, Revlimid's sales have been under pressure. For example, in the third quarter of 2023, Revlimid sales were $1.43 billion, a 41% decrease from the same period in 2022. BMS has revised its guidance for Revlimid, expecting sales to step down to about $4 billion in 2024 from $5.5 billion to $6 billion in 2023[5].

Competitive Landscape

The competitive landscape for Revlimid is becoming increasingly challenging. The entry of generic competitors has reduced BMS's market share, and the company is facing pressure to launch or acquire new drugs to replace the declining revenue from Revlimid. Other BMS products, such as Opdivo and Eliquis, are also facing patent exclusivity losses in the near future, further complicating the company's revenue outlook[5].

Strategic Initiatives to Mitigate Revenue Decline

BMS is actively pursuing several strategies to mitigate the revenue decline from Revlimid:

  • New Product Launches: BMS is focusing on new products like Camzyos, Reblozyl, and Sotyktu to replace the revenue lost from Revlimid. However, the ramp-up for these products is taking longer than expected[5].
  • Acquisitions: The company has acquired Mirati Therapeutics to broaden its oncology portfolio, particularly with the promising non-small cell lung cancer therapy Krazati[5].
  • Patient Assistance Programs: BMS is also offering patient assistance programs, which, while beneficial for patients, reduce the company's revenue from Revlimid sales[5].

Market Drivers and Barriers

Drivers:

  • Efficacy and Safety Profile: Revlimid's demonstrated efficacy in treating multiple myeloma and other lymphomas, along with its good safety and tolerability profile, continue to drive demand[4].
  • Expanding Indications: Ongoing clinical trials and expanding indications for Revlimid support its market presence[4].
  • Strategic Partnerships: Patent extensions and strategic partnerships further strengthen Revlimid's market position[4].

Barriers:

  • Generic Competition: The introduction of generic versions is the most significant barrier, leading to substantial revenue declines[2][5].
  • Pricing Pressure: The need to balance pricing with the availability of cheaper generics is a significant challenge[3].

Financial Impact on BMS

The decline in Revlimid sales has had a notable financial impact on BMS:

  • Revenue Projections: BMS has adjusted its revenue projections downward due to the faster-than-expected erosion of Revlimid sales[2][5].
  • Share Performance: The company's shares have been affected by the negative news, with a 4% drop following the announcement of lower-than-expected Revlimid sales[2].

Key Takeaways

  • Revlimid's market is facing significant challenges due to generic competition.
  • Historical revenue performance was strong, but current trends indicate a decline.
  • BMS is pursuing new product launches and acquisitions to replace lost revenue.
  • The drug's efficacy and safety profile continue to drive demand, but pricing pressure and generic competition are major barriers.

FAQs

1. What is the current market size of Revlimid?

The global Revlimid market was valued at approximately $8 billion in 2023[4].

2. How is generic competition affecting Revlimid sales?

Generic competition has led to a significant decline in Revlimid sales, particularly internationally, with a 23% drop in sales outside the U.S. in the first quarter of 2022[2].

3. What are BMS's strategies to replace the declining revenue from Revlimid?

BMS is focusing on new product launches like Camzyos, Reblozyl, and Sotyktu, and has acquired Mirati Therapeutics to broaden its oncology portfolio[5].

4. What are the key drivers of the Revlimid market?

The key drivers include the drug's efficacy and safety profile, expanding indications, and strategic partnerships[4].

5. How has the financial performance of BMS been impacted by the decline in Revlimid sales?

BMS has adjusted its revenue projections downward, and the company's shares have been negatively affected by the news of lower-than-expected Revlimid sales[2][5].

Cited Sources:

  1. Valuates Reports - Global Revlimid Industry Research Report[1].
  2. FiercePharma - BMS' Revlimid revenues hit by onset of generics[2].
  3. House Oversight Committee - Drug Pricing Investigation Report[3].
  4. Market Research Intellect - Revlimid Market Size, Share and Trends[4].
  5. BioSpace - BMS Pushes Back Target Sales for New Drugs as Q3 Revenue Declines[5].

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