THALIDOMIDE Drug Patent Profile
✉ Email this page to a colleague
When do Thalidomide patents expire, and what generic alternatives are available?
Thalidomide is a drug marketed by Natco and is included in one NDA.
The generic ingredient in THALIDOMIDE 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.
Summary for THALIDOMIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 508 |
| Patent Applications: | 2,069 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for THALIDOMIDE |
| DailyMed Link: | THALIDOMIDE at DailyMed |
Recent Clinical Trials for THALIDOMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shenyang Tenth People's Hospital | Phase 2 |
| Beijing Tsinghua Changgeng Hospital | Phase 2 |
| University Hopsital Schleswig Holstein Campus Lübeck | Phase 2/Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Natco | THALIDOMIDE | thalidomide | CAPSULE;ORAL | 213267-001 | Apr 27, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
