THALIDOMIDE - Generic Drug Details

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What are the generic sources for thalidomide and what is the scope of freedom to operate?

Thalidomide is the generic ingredient in two branded drugs marketed by Natco and Bristol-myers, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for thalidomide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for THALIDOMIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	512
Patent Applications:	6,819
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for THALIDOMIDE
What excipients (inactive ingredients) are in THALIDOMIDE?	THALIDOMIDE excipients list
DailyMed Link:	THALIDOMIDE at DailyMed

Recent Clinical Trials for THALIDOMIDE

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

Sponsor	Phase
Mayo Clinic	Phase 1
Shenyang Tenth People's Hospital	Phase 2
Beijing Tsinghua Changgeng Hospital	Phase 2

See all THALIDOMIDE clinical trials

Generic filers with tentative approvals for THALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	CAPSULE; ORAL
⤷ Sign Up	⤷ Sign Up	150MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	200MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for THALIDOMIDE

Physiological Effect	Decreased Immunologically Active Molecule Activity

Medical Subject Heading (MeSH) Categories for THALIDOMIDE

Angiogenesis Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Teratogens

Anatomical Therapeutic Chemical (ATC) Classes for THALIDOMIDE

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

Paragraph IV (Patent) Challenges for THALIDOMIDE

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 THALIDOMIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco	THALIDOMIDE	thalidomide	CAPSULE;ORAL	213267-001	Apr 27, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 THALIDOMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	⤷ Sign Up	⤷ Sign Up
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	⤷ Sign Up	⤷ Sign Up
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	⤷ Sign Up	⤷ Sign Up
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for THALIDOMIDE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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