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Profile for Tradename: REVLIMID

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Revlimid is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are twenty-four patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in REVLIMID is lenalidomide. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.

Summary for Tradename: REVLIMID

Suppliers: see list1

Pharmacology for Tradename: REVLIMID

Clinical Trials for: REVLIMID

Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
Status: Recruiting Condition: Multiple Myeloma

Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer
Status: Terminated Condition: Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas
Status: Active, not recruiting Condition: Follicular Lymphoma; Marginal Zone B-Cell Lymphoma; MALT Lymphoma; Lymphoma of Mucosa-Associated Lymphoid Tissue; Lymphoma, Small Lymphocytic; Waldenstrom Macroglobulinemia; Mantle-Cell Lymphoma

Revlimid / All-Trans Retinoic Acid (ATRA) / Dexamethasone in Relapsed/Refractory Multiple Myeloma
Status: Active, not recruiting Condition: Myeloma

Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma
Status: Recruiting Condition: Multiple Myeloma

Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)
Status: Recruiting Condition: Chronic Lymphocytic Leukemia; CLL; Untreated; Front-line; First-Line; Initial Therapy

Dasatinib in Combination With Revlimid (and Dexamethasone)
Status: Completed Condition: Multiple Myeloma

A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes
Status: Completed Condition: Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)

Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma
Status: Recruiting Condition: Relapsed Multiple Myeloma

A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
Status: Completed Condition: Multiple Myeloma

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL021880-004Jun 29, 2006RXYes8,648,095<disabled><disabled>
CAPSULE;ORAL021880-006Jun 5, 2013RXNo8,589,188<disabled><disabled>
CAPSULE;ORAL021880-003Jun 29, 2006RXNo7,968,569<disabled><disabled>
CAPSULE;ORAL021880-002Dec 27, 2005RXNo6,555,554<disabled>Y<disabled>
CAPSULE;ORAL021880-005Dec 21, 2011RXNo8,530,498<disabled><disabled>
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Paragraph IV activity for: REVLIMID

Drugname Dosage Strength RLD Submissiondate
lenalidomideCapsules5 mg, 10 mg and 15 mgRevlimid8/30/2010
lenalidomideCapsules25 mgRevlimid7/12/2010
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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