Alemtuzumab - Biologic Drug Details

Summary for alemtuzumab

Tradenames:	2
Patents:	7
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for alemtuzumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alemtuzumab

Recent Clinical Trials for alemtuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Neovii Biotech	Phase 2
Clinical Trial Center North (CTC North GmbH & Co. KG)	Phase 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	N/A

See all alemtuzumab clinical trials

Recent Litigation for alemtuzumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AMGEN INC. v. APOTEX INC.	2022-06-14
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11

See all alemtuzumab litigation

PTAB Litigation

Petitioner	Date
Miltenyi Biomedicine GmbH	2022-04-12
GEMoaB Monoclonals GmbH	2019-12-20
Forty Seven, Inc.	2018-01-08

See all alemtuzumab litigation

Pharmacology for alemtuzumab

Mechanism of Action	CD52-directed Antibody Interactions
Established Pharmacologic Class	CD52-directed Cytolytic Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for alemtuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for alemtuzumab Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2013-08-13	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2013-08-13	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2014-08-05	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2015-12-08	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2013-12-28	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2020-05-27	Company disclosures

3) Low Certainty: US Patents for alemtuzumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2033-03-11	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2028-04-10	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2039-02-26	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2033-02-08	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2034-11-21	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2023-07-24	Patent claims search

International Patents for alemtuzumab

Country	Patent Number	Estimated Expiration
Spain	2332905
United Kingdom	9122820
Germany	69435270
Netherlands	300067
Canada	2300433
Australia	712502

Supplementary Protection Certificates for alemtuzumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016/024	Ireland		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 20130912
C 2016 020	Romania		PRODUCT NAME: ALEMTUZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/13/869; DATE OF NATIONAL AUTHORISATION: 20130912; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/869; DATE OF FIRST AUTHORISATION IN EEA: 20130912
132016000055697	Italy		PRODUCT NAME: ALEMTUZUMAB(LEMTRADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/869, 20130916
132008901655481	Italy		PRODUCT NAME: NEUROTOSSINA DI CLOSTRIDIUM BOTULINUM DI TIPO A (150 KD) PRIVA DI PROTEINE COMPLESSATE(XEOMIN); AUTHORISATION NUMBER(S) AND DATE(S): 838, 20080409;57093.00.00, 20050531
SZ 32/2001	Austria		PRODUCT NAME: ALEMTUZUMAB
253 5012-2016	Slovakia		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 20130916