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Mavenclad patents expiration

MAVENCLAD's oppositions filed in EPO
MAVENCLAD IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7888328 EMD SERONO INC Oral formulations of cladribine
Apr, 2024

(2 months ago)

US8785415 EMD SERONO INC Oral formulations of cladribine
Apr, 2024

(2 months ago)

US8377903 EMD SERONO INC Cladribine regimen for treating multiple sclerosis
May, 2026

(1 year, 11 months from now)

US7713947 EMD SERONO INC Cladribine regimen for treating multiple sclerosis
Oct, 2026

(2 years from now)

US10849919 EMD SERONO INC Cladribine regimen for treating progressive forms of multiple sclerosis
Nov, 2038

(14 years from now)

Mavenclad is owned by Emd Serono Inc.

Mavenclad contains Cladribine.

Mavenclad has a total of 5 drug patents out of which 2 drug patents have expired.

Expired drug patents of Mavenclad are:

  • US7888328
  • US8785415

Mavenclad was authorised for market use on 29 March, 2019.

Mavenclad is available in tablet;oral dosage forms.

Mavenclad can be used as 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, 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, 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, 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, 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.

The generics of Mavenclad are possible to be released after 23 November, 2038.

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 29, 2022

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Drugs and Companies using CLADRIBINE ingredient

Market Authorisation Date: 29 March, 2019

Treatment: 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-inclusi...

Dosage: TABLET;ORAL

How can I launch a generic of MAVENCLAD before it's drug patent expiration?
More Information on Dosage

MAVENCLAD family patents

Family Patents