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 Bristol-myers and is included in one NDA.
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.
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Summary for THALOMID
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 73 |
| Patent Applications: | 4,389 |
| 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 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | RX | Yes | 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 THALOMID
| 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 |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| European Patent Office | 1330765 | ⤷ Sign Up | |
| Denmark | 0963200 | ⤷ Sign Up | |
| South Africa | 200503927 | Pharmaceutical compositions and dosage forms of thalidomide | ⤷ Sign Up |
| Japan | 2001278789 | PHARMACEUTICAL PREPARATION WITH THALIDOMIDE AS ACTIVE INGREDIENT | ⤷ Sign Up |
| China | 101816626 | Pharmaceutical compositions and dosage forms of thalidomide | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for THALOMID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0688211 | C300358 | Netherlands | ⤷ Sign Up | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
| 0688211 | CA 2008 00034 | Denmark | ⤷ Sign Up | |
| 0688211 | SPC025/2008 | Ireland | ⤷ Sign Up | SPC025/2008: 20090811, EXPIRES: 20190223 |
| 0688211 | SPC/GB08/039 | United Kingdom | ⤷ Sign Up | 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 | 91471 | Luxembourg | ⤷ Sign Up | 91471, EXPIRES: 20190224 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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