Thalidomide - Generic Drug Details
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What are the generic sources for thalidomide and what is the scope of patent protection?
Thalidomide
is the generic ingredient in two branded drugs marketed by Natco and Bristol-myers, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for thalidomide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for thalidomide
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 11 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 512 |
| Patent Applications: | 6,819 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for thalidomide |
| What excipients (inactive ingredients) are in thalidomide? | thalidomide excipients list |
| DailyMed Link: | thalidomide at DailyMed |
Recent Clinical Trials for thalidomide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 1 |
| Shenyang Tenth People's Hospital | Phase 2 |
| Beijing Tsinghua Changgeng Hospital | Phase 2 |
Generic filers with tentative approvals for THALIDOMIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for thalidomide
| Physiological Effect | Decreased Immunologically Active Molecule Activity |
Medical Subject Heading (MeSH) Categories for thalidomide
Anatomical Therapeutic Chemical (ATC) Classes for thalidomide
Paragraph IV (Patent) Challenges for THALIDOMIDE
| 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 thalidomide
| 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 | 020785-004 | Jan 10, 2007 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | 020785-002 | Jan 17, 2003 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Natco | THALIDOMIDE | thalidomide | CAPSULE;ORAL | 213267-001 | Apr 27, 2023 | DISCN | No | 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 | ||||
| >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 thalidomide
| 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 thalidomide
| 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 |
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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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