Generic Mavenclad Availability

Last updated on Sep 11, 2024.

Mavenclad is a brand name of cladribine, approved by the FDA in the following formulation(s):

MAVENCLAD (cladribine - tablet;oral)

Manufacturer: EMD SERONO INC
Approval date: March 29, 2019
Strength(s): 10MG ^[RLD]

Has a generic version of Mavenclad been approved?

No. There is currently no therapeutically equivalent version of Mavenclad available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mavenclad. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Cladribine regimen for treating progressive forms of multiple sclerosis
Patent 10,849,919
Issued: December 1, 2020
Inventor(s): Dangond Fernando & Dotzauer Matthias
Assignee(s): Merck Patent GmbH
Specific oral dosings, specific oral dosage forms, and/or specific oral dose regimens including Cladribine can be effective for the treatment of progressive forms of Multiple Sclerosis, especially Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis. Methods of treatment can be based on specific oral dosings, specific oral dosage forms, and/or specific oral dose regimens including Cladribine.
Patent expiration dates:
- November 23, 2038
  ✓
  Patent use: TREATING NON-EARLY SPMS BY ADMINISTERING ORAL CLADRIBINE AT A FIXED DOSE PER PATIENT, PER BODY WEIGHT AND PER TREATMENT YEAR, WHICH FIXED DOSE IS 1.75 +/- 0.2 MG/KG, TO BE ADMINISTERED WITHIN MONTHS 1 AND 2 IN EACH OF 2 ADJACENT TREATMENT YEARS
Patent 7,713,947
Patent expiration dates:
- October 16, 2026
  ✓
  Patent use: TREATING MS WITH ORAL CLADRIBINE ACC. TO THE STEPS (I) INDUCTION PERIOD WITH ABOUT 1.7 MG/KG-3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) MAINTENANCE PERIOD WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD
Patent 7,888,328
Patent expiration dates:
- April 11, 2024
  ✓
  Patent use: TREATMENT OF MS WITH A TABLET WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE AND HYDROXYPROPYL-B-CYCLODEXTRIN AND (B) AMORPHOUS FREE CLADRIBINE AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, CLADRIBINE/CYCLODEXTRIN 1:10-1:16 W/W
  ✓
  Drug product
Cladribine regimen for treating multiple sclerosis
Patent 8,377,903
Issued: February 19, 2013
Inventor(s): De Luca Giampiero & Ythier Arnaud & Munafo Alain & Lopez-Bresnahan Maria
Assignee(s): Merck Serono SA
The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be the orally administered and wherein re-treatments are possible.
Patent expiration dates:
- May 31, 2026
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  Patent use: TREATING RRMS OR SPMS WITH ORAL CLADRIBINE: (I) 2-4 MONTHS INDUCTION WITH 1.7 MG/KG - 3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) 2-4 MONTHS MAINTENANCE WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD
Oral formulations of cladribine
Patent 8,785,415
Issued: July 22, 2014
Inventor(s): Bodor Nicholas S. & Dandiker Yogesh
Assignee(s): Ares Trading S.A.
Provided are compositions of cladribine and cyclodextrin which are especially suited for the oral administration of cladribine.
Patent expiration dates:
- April 11, 2024
  ✓
  Patent use: TREATMENT OF MS WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE (2CDA) AND CYCLODEXTRIN AND (B) AMORPHOUS FREE 2CDA AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, FORMULATED AS A SOLID ORAL FORM, W/O SIGN. AMOUNTS OF CRYST. 2CDA
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  Drug product

More about Mavenclad (cladribine)

Patient resources

Mavenclad drug information

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Professional resources

Related treatment guides

Multiple Sclerosis

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

4 Reviews

Images

Pill C 10 is Mavenclad 10 mg — Mavenclad 10 mg (C 10)