MAVENCLAD Drug Patent Profile
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When do Mavenclad patents expire, and what generic alternatives are available?
Mavenclad is a drug marketed by Emd Serono Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-one patent family members in thirty-five countries.
The generic ingredient in MAVENCLAD is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mavenclad
A generic version of MAVENCLAD was approved as cladribine by HIKMA on February 28th, 2000.
Summary for MAVENCLAD
| International Patents: | 151 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 11 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MAVENCLAD |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MAVENCLAD |
| What excipients (inactive ingredients) are in MAVENCLAD? | MAVENCLAD excipients list |
| DailyMed Link: | MAVENCLAD at DailyMed |
Recent Clinical Trials for MAVENCLAD
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Plymouth | Phase 2/Phase 3 |
| University College, London | Phase 2/Phase 3 |
| University of Leeds | Phase 2/Phase 3 |
Pharmacology for MAVENCLAD
| Drug Class | Purine Antimetabolite |
Anatomical Therapeutic Chemical (ATC) Classes for MAVENCLAD
Paragraph IV (Patent) Challenges for MAVENCLAD
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MAVENCLAD | Tablets | cladribine | 10 mg | 022561 | 1 | 2022-04-07 |
US Patents and Regulatory Information for MAVENCLAD
MAVENCLAD is protected by five US patents.
Patents protecting MAVENCLAD
Cladribine regimen for treating progressive forms of multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented 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
Cladribine regimen for treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented 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
Oral formulations of cladribine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented 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
Cladribine regimen for treating multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented 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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for MAVENCLAD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for MAVENCLAD
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merck Europe B.V. | Mavenclad | cladribine | EMEA/H/C/004230 Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. |
Authorised | no | no | no | 2017-08-22 | |
| Lipomed GmbH | Litak | cladribine | EMEA/H/C/000504 Litak is indicated for the treatment of hairy-cell leukaemia. |
Authorised | no | no | no | 2004-04-14 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for MAVENCLAD
See the table below for patents covering MAVENCLAD around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Lithuania | C1608344 | ⤷ Sign Up | |
| Canada | 2520522 | PREPARATIONS A BASE DE CLADRIBINE PERMETTANT UNE ADMINISTRATION ORALE ET TRANSMUCOSALE AMELIOREE (CLADRIBINE FORMULATIONS FOR IMPROVED ORAL AND TRANSMUCOSAL DELIVERY) | ⤷ Sign Up |
| Canada | 2588966 | SCHEMA POSOLOGIQUE A BASE DE CLADRIBINE DESTINE A TRAITER LASCLEROSE EN PLAQUES (CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS) | ⤷ Sign Up |
| Hungary | E059133 | ⤷ Sign Up | |
| Ukraine | 96260 | РЕЖИМ ПРИМЕНЕНИЯ КЛАДРИБИНА ДЛЯ ЛЕЧЕНИЯ РАССЕЯННОГО СКЛЕРОЗА;РЕЖИМ ЗАСТОСУВАННЯ КЛАДРИБІНУ ДЛЯ ЛІКУВАННЯ РОЗСІЯНОГО СКЛЕРОЗУ (CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MAVENCLAD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1827461 | C201830015 | Spain | ⤷ Sign Up | PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822 |
| 1827461 | CR 2018 00010 | Denmark | ⤷ Sign Up | PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824 |
| 1608344 | C20180007 00334 | Estonia | ⤷ Sign Up | PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017 |
| 1827461 | 122018000021 | Germany | ⤷ Sign Up | PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822 |
| 2805723 | LUC00064 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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ISSN: 2162-2639
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