REVLIMID Drug Patent Profile

Which patents cover Revlimid, 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 21^st, 2021.

Summary for REVLIMID

International Patents:	331
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	553
Patent Applications:	4,186
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
City of Hope Medical Center	Phase 2
Regeneron Pharmaceuticals	Phase 3
Wuhan Union Hospital, China	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 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	7,855,217		Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	AB	RX	Yes	Yes	7,465,800		Y	Y
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	AB	RX	Yes	No	8,741,929
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	AB	RX	Yes	No	8,741,929

Expired US Patents for REVLIMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	9,056,120
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	6,755,784
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	8,530,498
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	7,189,740
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	6,561,976
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	7,468,363

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
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
Krka, d.d., Novo mesto	Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)	lenalidomide	EMEA/H/C/005734 Multiple myelomaLenalidomide krka d.d. Novo mesto 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. Novo mesto 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. Novo mesto 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 krka d.d. Novo mesto 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 d.d. Novo mesto 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. Novo mesto 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. Novo mesto 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 krka d.d. Novo mesto 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

International Patents for REVLIMID

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	9199	2,6-DIOXOPIPERIDINES, PHARMACEUTICAL COMPOSITION THEM CONTAINING AND THEIR USE
New Zealand	570777	Methods and compositions using selective cytokine inhibitory drugs for treatment and management of cancers and other diseases
Japan	2015131863	置換２−（２，６−ジオキソピペリジン−３−イル）フタルイミド類及び−１−オキソイソインドリン類ならびにＴＮＦαレベルの減少方法 (SUBSTITUTED 2-(2,6-DIOXOPIPERIDIN-3-YL)PHTHALIMIDES AND 1-OXOISOINDOLINES, AND METHOD OF REDUCING TNF-α LEVELS)
South Korea	20050072801	METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES
South Africa	200601858	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydroisoindol-2-yl)-piperidine-2,6-dione
Croatia	P20100664

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	C20150005 00140	Estonia		PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
0925294	C00925294/01	Switzerland		PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
0925294	CA 2007 00054	Denmark		PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
0925294	07C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
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

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].