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THALOMID Drug Profile
» See Plans and Pricing
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 are nine patents protecting this drug and three Paragraph IV challenges.
This drug has forty-seven 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.
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: | 47 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 126 |
| Clinical Trials: | 72 |
| Patent Applications: | 79 |
| 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 |
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 |
Paragraph IV (Patent) Challenges for THALOMID
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2014-02-03 |
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2006-12-18 |
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2006-09-25 |
US Patents and Regulatory Information for 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 | 020785-004 | Jan 10, 2007 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | RX | Yes | No | Start Trial | Start Trial | Start 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 | 020785-003 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for THALOMID
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69434490 | Start Trial |
| Israel | 168585 | Start Trial |
| Denmark | 1562556 | Start Trial |
| Netherlands | 300358 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for THALOMID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0688211 | 08C0036 | France | Start Trial | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
| 0688211 | SPC025/2008 | Ireland | Start Trial | SPC025/2008: 20090811, EXPIRES: 20190223 |
| 0688211 | 300358 | Netherlands | Start Trial | 300358, 20140224, EXPIRES: 20190223 |
| 0688211 | 91471 | Luxembourg | Start Trial | 91471, EXPIRES: 20190224 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
