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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Questions you can ask:
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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: | 4,475 |
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 | 020785-001 | Jul 16, 1998 | ⤷ 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 | 020785-003 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | 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 | 1245229 | ⤷ Sign Up | |
European Patent Office | 0688211 | THALIDOMIDE POUR INHIBER L'ANGIOGENESE (THALIDOMIDE FOR INHIBITION OF ANGIOGENESIS) | ⤷ Sign Up |
Australia | 2010200186 | ⤷ Sign Up | |
Austria | 304356 | ⤷ 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 | 91471 | Luxembourg | ⤷ Sign Up | 91471, EXPIRES: 20190224 |
0688211 | CA 2008 00034 | Denmark | ⤷ Sign Up | |
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 | 300358 | Netherlands | ⤷ Sign Up | 300358, 20140224, EXPIRES: 20190223 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |