POMALIDOMIDE Drug Patent Profile
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Which patents cover Pomalidomide, and when can generic versions of Pomalidomide launch?
Pomalidomide is a drug marketed by Apotex, Breckenridge, Eugia Pharma, Hetero Labs Ltd V, Mylan, and Teva Pharms Usa. and is included in six NDAs.
The generic ingredient in POMALIDOMIDE is pomalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pomalidomide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pomalidomide
A generic version of POMALIDOMIDE was approved as pomalidomide by APOTEX on June 11th, 2024.
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Questions you can ask:
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Summary for POMALIDOMIDE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 147 |
| Clinical Trials: | 253 |
| Patent Applications: | 2,650 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for POMALIDOMIDE |
| DailyMed Link: | POMALIDOMIDE at DailyMed |
Recent Clinical Trials for POMALIDOMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Megalabs | Phase 1 |
| University of Chicago | Phase 2 |
| Regeneron Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for POMALIDOMIDE
Paragraph IV (Patent) Challenges for POMALIDOMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| POMALYST | Capsules | pomalidomide | 1 mg, 2 mg, 3 mg and 4 mg | 204026 | 6 | 2017-02-08 |
US Patents and Regulatory Information for POMALIDOMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210164-001 | Jun 11, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210275-002 | Jan 26, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Usa | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 209956-004 | May 4, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Breckenridge | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210111-003 | Oct 30, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210164-004 | Jun 11, 2024 | AB | RX | No | 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 |
EU/EMA Drug Approvals for POMALIDOMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Bristol-Myers Squibb Pharma EEIG | Imnovid (previously Pomalidomide Celgene) | pomalidomide | EMEA/H/C/002682 Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. |
Authorised | no | no | no | 2013-08-05 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
