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.
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: | 136 |
Clinical Trials: | 73 |
Patent Applications: | 4,814 |
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 Generic Entry Opportunity 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 |
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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | 020785-001 | Jul 16, 1998 | See Plans and Pricing | See Plans and Pricing |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | See Plans and Pricing | See Plans and Pricing |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | See Plans and Pricing | See Plans and Pricing |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | See Plans and Pricing | See Plans and Pricing |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | See Plans and Pricing | See Plans and Pricing |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | See Plans and Pricing | See Plans and Pricing |
Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for THALOMID
When does loss-of-exclusivity occur for THALOMID?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03290982
Estimated Expiration: See Plans and Pricing
Patent: 10201931
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 16240
Estimated Expiration: See Plans and Pricing
Canada
Patent: 05964
Estimated Expiration: See Plans and Pricing
China
Patent: 38607
Estimated Expiration: See Plans and Pricing
Patent: 1816626
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 13929
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 62556
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 62556
Estimated Expiration: See Plans and Pricing
Patent: 77512
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 88543
Estimated Expiration: See Plans and Pricing
Israel
Patent: 8585
Estimated Expiration: See Plans and Pricing
Japan
Patent: 27905
Estimated Expiration: See Plans and Pricing
Patent: 69280
Estimated Expiration: See Plans and Pricing
Patent: 06508983
Estimated Expiration: See Plans and Pricing
Patent: 09215310
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05005162
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0545
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 62556
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 62556
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0503927
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 0671366
Estimated Expiration: See Plans and Pricing
Patent: 050086624
Estimated Expiration: See Plans and Pricing
Spain
Patent: 03142
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 59659
Estimated Expiration: See Plans and Pricing
Patent: 77062
Estimated Expiration: See Plans and Pricing
Patent: 0505449
Estimated Expiration: See Plans and Pricing
Patent: 0731973
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering THALOMID around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 0235440 | See Plans and Pricing | |
Australia | 780296 | See Plans and Pricing | |
European Patent Office | 1537870 | See Plans and Pricing | |
Germany | 69740095 | See Plans and Pricing | |
European Patent Office | 1264597 | Compositions pour le traitement du cancer (Compositions for treating cancer) | See Plans and Pricing |
Japan | 2009233326 | METHOD FOR DELIVERING DRUG TO PATIENT WHILE AVOIDING OCCURRENCE OF ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY THE DRUG | See Plans and Pricing |
Australia | 6248694 | See Plans and Pricing | |
>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 | See Plans and Pricing | |
0620232 | 08C0036 | France | See Plans and Pricing | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
0688211 | 300358 | Netherlands | See Plans and Pricing | 300358, 20140224, EXPIRES: 20190223 |
0688211 | C300358 | Netherlands | See Plans and Pricing | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
0688211 | SPC/GB08/039 | United Kingdom | See Plans and Pricing | PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416 |
0688211 | 08C0036 | France | See Plans and Pricing | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
0688211 | 91471 | Luxembourg | See Plans and Pricing | 91471, EXPIRES: 20190224 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |