Pharsight

Mavenclad is owned by Emd Serono Inc.

Mavenclad contains Cladribine.

Mavenclad has a total of 5 drug patents out of which 0 drug patents have expired.

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

Mavenclad is available in tablet;oral dosage forms.

Mavenclad can be used as 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, 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 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, 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, 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.

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

Patent Number	Company	Patent Title	Patent Expiry
These 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 (1 year, 2 months from now)
US8785415	EMD SERONO INC	Oral formulations of cladribine	Apr, 2024 (1 year, 2 months from now)
US8377903	EMD SERONO INC	Cladribine regimen for treating multiple sclerosis	May, 2026 (3 years from now)
US7713947	EMD SERONO INC	Cladribine regimen for treating multiple sclerosis	Oct, 2026 (3 years from now)
US10849919	EMD SERONO INC	Cladribine regimen for treating progressive forms of multiple sclerosis	Nov, 2038 (15 years from now)

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

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-inclusion complex, cladribine/cyclodextrin 1:10-1:16 w/w; 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 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; Treating ms with oral cladribine acc. to the steps (i) induction period with about 1.7 mg/kg-3.5 mg/kg cladribine; (iii) maintenance period with about 1.7 mg/kg cladribine; 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

Dosage: TABLET;ORAL