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 Breckenridge, Eugia Pharma, Mylan, and Teva Pharms Usa. and is included in four 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.
Summary for POMALIDOMIDE
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 147 |
Clinical Trials: | 249 |
Patent Applications: | 3,369 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Chicago | Phase 2 |
Regeneron Pharmaceuticals | Phase 3 |
Onward Therapeutics | Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Breckenridge | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210111-001 | Oct 30, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eugia Pharma | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210249-003 | Oct 30, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Breckenridge | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210111-004 | Oct 30, 2020 | 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 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 |