THALOMID Drug Patent Profile
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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 |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for THALOMID
Generic Entry Date for THALOMID*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Pharmacology for THALOMID
Physiological Effect | Decreased Immunologically Active Molecule Activity |
Anatomical Therapeutic Chemical (ATC) Classes for THALOMID
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of THALOMID is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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
Pharmaceutical compositions and dosage forms of thalidomide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 THALOMID
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for THALOMID
See the table below for patents covering THALOMID around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 0963200 | ⤷ Try a Trial | |
European Patent Office | 2226740 | ⤷ Try a Trial | |
European Patent Office | 1970827 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for THALOMID
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0688211 | CA 2008 00034 | Denmark | ⤷ Try a Trial | |
0688211 | 91471 | Luxembourg | ⤷ Try a Trial | 91471, EXPIRES: 20190224 |
0688211 | SPC025/2008 | Ireland | ⤷ Try a Trial | SPC025/2008: 20090811, EXPIRES: 20190223 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |