THALOMID Drug Patent Profile

Which patents cover Thalomid, and what generic alternatives are available?

Thalomid is a drug marketed by Bristol-myers and is included in one NDA.

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.

Summary for THALOMID

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	73
Patent Applications:	4,474
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

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

Pharmacology for THALOMID

Physiological Effect

Decreased Immunologically Active Molecule Activity

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

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

EU/EMA Drug Approvals for THALOMID

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Thalidomide BMS (previously Thalidomide Celgene)	thalidomide	EMEA/H/C/000823 Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy., , Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).,	Authorised	no	no	no	2008-04-16
Lipomed GmbH	Thalidomide Lipomed	thalidomide	EMEA/H/C/005715 Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).	Authorised	no	no	no	2022-09-19

International Patents for THALOMID

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

Country	Patent Number	Title	Estimated Expiration
Portugal	688211
Netherlands	300358
New Zealand	541736	Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
Denmark	1264597
European Patent Office	1245229
New Zealand	262676	METHOD OF INHIBITING ANGIOGENESIS IN A NON-HUMAN ANIMAL USING THALIDOMIDE AND ANALOGUES THEREOF

Supplementary Protection Certificates for THALOMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0688211	300358	Netherlands		300358, 20140224, EXPIRES: 20190223
0688211	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0688211	CA 2008 00034	Denmark
0688211	91471	Luxembourg		91471, EXPIRES: 20190224
0688211	C300358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
0620232	08C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416