THALOMID Drug Patent Profile

When do Thalomid patents expire, and when can generic versions of Thalomid launch?

Thalomid is a drug marketed by Celgene and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has twenty-nine patent family members in nineteen countries.

The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.

DrugPatentWatch^® Generic Entry Outlook for Thalomid

Thalomid was eligible for patent challenges on July 16, 2002.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 9, 2023. This may change due to patent challenges or generic licensing.

There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for THALOMID

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	73
Patent Applications:	4,814
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for THALOMID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for THALOMID
What excipients (inactive ingredients) are in THALOMID?	THALOMID excipients list
DailyMed Link:	THALOMID at DailyMed

See drug prices for THALOMID

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for THALOMID

NDA:

020785

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for THALOMID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Emory University	Phase 2
Janssen Scientific Affairs, LLC	Phase 2
Nanfang Hospital of Southern Medical University	Phase 3

See all THALOMID clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for THALOMID

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for THALOMID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THALOMID	Capsules	thalidomide	150 mg	020785	1	2014-02-03
THALOMID	Capsules	thalidomide	50 mg and 100 mg	020785	1	2006-12-18
THALOMID	Capsules	thalidomide	200 mg	020785	1	2006-09-25

US Patents and Regulatory Information for THALOMID

THALOMID is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting THALOMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998		RX	Yes	No			Y
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes			Y
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003		RX	Yes	No			Y
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007		RX	Yes	No

Expired US Patents for THALOMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003

International Patents for THALOMID

When does loss-of-exclusivity occur for THALOMID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering THALOMID around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0235440
Australia	780296
European Patent Office	1537870
Germany	69740095
European Patent Office	1264597	Compositions pour le traitement du cancer (Compositions for treating cancer)
Japan	2009233326	METHOD FOR DELIVERING DRUG TO PATIENT WHILE AVOIDING OCCURRENCE OF ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY THE DRUG
Australia	6248694

Supplementary Protection Certificates for THALOMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0688211	CA 2008 00034	Denmark
0620232	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	300358	Netherlands		300358, 20140224, EXPIRES: 20190223
0688211	C300358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	SPC/GB08/039	United Kingdom		PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416
0688211	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	91471	Luxembourg		91471, EXPIRES: 20190224