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THALOMID

NDA

THALIDOMIDE | N020785 | BRISTOL-MYERS SQUIBB CO

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CELGENE CORPORATION v. HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED et al 2:2018cv13477 9 patentsANDA 211947thalidomide	D.N.J.	2018-08-31	Terminated 2019-09-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma NCT00602641	Phase 3	Active	National Cancer Institute (NCI)	306	2008-02-29 → 2027-02-20
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma NCT07247097	Phase 2	Not Yet Recruiting	Massachusetts General Hospital	160	2026-08-01 → 2035-12-01
Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors NCT07671534	Phase 2	Recruiting	Sarcoma Oncology Research Center, LLC	60	2026-06 → 2029-06
Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis NCT06031012	Phase 3	Completed	Air Force Military Medical University, China	138	2023-09-15 → 2025-10-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Thalomid (2023)

Total Spending

$19.4M

Total Claims

2,709

Beneficiaries

500

Avg Cost/Unit

$242.40

Spending Trend

$35.1M(2019)→$33.1M(2020)→$28.9M(2021)→$24.5M(2022)→$19.4M(2023)

YoY Change:+0.6%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs6 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

OLON SPATHALIDOMIDE

DMF 184482005

HETERO LABS LTDTHALIDOMIDE USP

DMF 197452006

LAURUS LABS LTDTHALIDOMIDE USP

DMF 279672014

SHILPA PHARMA LIFESCIENCES LTDTHALIDOMIDE USP

DMF 330882018

ANDRULIS PHARMACEUTICALS CORPInactiveTHALIDOMIDE

DMF 82631989

PEDIATRIC PHARMACEUTICALS INCInactiveTHALIDOMIDE TABLETS

DMF 97681992

SIFAVITOR SPAInactiveTHALIDOMIDE

DMF 152912001

FIS FABBRICA ITALIANA SINTETICI SPAInactiveTHALIDOMIDE

DMF 218062008

DR REDDYS LABORATORIES LTDInactiveTHALIDOMIDE

DMF 226782009

MYLAN LABORATORIES LTDInactiveTHALIDOMIDE USP

DMF 294522015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

35 letters from Drugs@FDA

Date	Submission	Document
May 1, 2026	SUPPL -73	View Letter (PDF)
Mar 27, 2023	SUPPL -71	View Letter (PDF)
Aug 6, 2021	SUPPL -70	View Letter (PDF)
Mar 1, 2021	SUPPL -69	View Letter (PDF)
Dec 5, 2019	SUPPL -68	View Letter (PDF)
Jun 10, 2019	SUPPL -67	View Letter (PDF)
Dec 29, 2017	SUPPL -65	View Letter (PDF)
Dec 1, 2017	SUPPL -64	View Letter (PDF)
Jun 12, 2017	SUPPL -63	View Letter (PDF)
Jan 31, 2017	SUPPL -61	View Letter (PDF)
Apr 25, 2016	SUPPL -60	View Letter (PDF)
Dec 2, 2015	SUPPL -59	View Letter (PDF)
Oct 29, 2015	SUPPL -58	View Letter (PDF)
Sep 15, 2015	SUPPL -57	View Letter (PDF)
Aug 10, 2015	SUPPL -51	View Letter (PDF)
Sep 16, 2014	SUPPL -54	View Letter (PDF)
Jun 23, 2014	SUPPL -55	View Letter (PDF)
Nov 18, 2013	SUPPL -50	View Letter (PDF)
Feb 12, 2013	SUPPL -48	View Letter (PDF)
Feb 8, 2012	SUPPL -40	View Letter (PDF)
Feb 8, 2012	SUPPL -35	View Letter (PDF)
Feb 8, 2012	SUPPL -43	View Letter (PDF)
Aug 6, 2010	SUPPL -39	View Letter (PDF)
Jan 16, 2007	SUPPL -32	View Letter (PDF)
May 26, 2006	SUPPL -31	View Letter (PDF)
Jun 18, 2004	SUPPL -21	View Letter (PDF)
Mar 10, 2004	SUPPL -26	View Letter (PDF)
Mar 10, 2004	SUPPL -25	View Letter (PDF)
Oct 31, 2003	SUPPL -22	View Letter (PDF)
Oct 31, 2003	SUPPL -24	View Letter (PDF)
Oct 31, 2003	SUPPL -23	View Letter (PDF)
Jan 17, 2003	SUPPL -20	View Letter (PDF)
Sep 5, 2001	SUPPL -14	View Letter (PDF)
Sep 5, 2001	SUPPL -12	View Letter (PDF)
Jul 16, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 16, 1998

No patent or exclusivity listings for this strength.

#002 — 100MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 17, 2003

#003 — 200MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 17, 2003

#004 — 150MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 10, 2007