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.

There is one tentative approval for the generic drug (thalidomide), which indicates the potential for near-term generic launch.

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:	148
Clinical Trials:	73
Patent Applications:	5,027
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 Loss of Exclusivity (LOE) 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

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

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

Expired US Patents for THALOMID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003

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
Denmark	0963200
European Patent Office	2226740
European Patent Office	1970827

Supplementary Protection Certificates for THALOMID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0688211	CA 2008 00034	Denmark
0688211	91471	Luxembourg		91471, EXPIRES: 20190224
0688211	SPC025/2008	Ireland		SPC025/2008: 20090811, EXPIRES: 20190223