DECITABINE Drug Patent Profile
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Which patents cover Decitabine, and when can generic versions of Decitabine launch?
Decitabine is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm. and is included in nineteen NDAs.
The generic ingredient in DECITABINE is decitabine. There are eighteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the decitabine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Decitabine
A generic version of DECITABINE was approved as decitabine by DR REDDYS on July 11th, 2013.
Summary for DECITABINE
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 443 |
| Patent Applications: | 2,347 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DECITABINE |
| What excipients (inactive ingredients) are in DECITABINE? | DECITABINE excipients list |
| DailyMed Link: | DECITABINE at DailyMed |
Recent Clinical Trials for DECITABINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Innovative Therapies For Children with Cancer Consortium | Phase 1/Phase 2 |
| IBFM | Phase 1/Phase 2 |
| Princess Maxima Center for Pediatric Oncology | Phase 1/Phase 2 |
Pharmacology for DECITABINE
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DECITABINE
US Patents and Regulatory Information for DECITABINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 203475-001 | Feb 27, 2017 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 214486-001 | Nov 19, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Jiangsu Hansoh Pharm | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 213472-001 | Apr 15, 2022 | AP | RX | 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 DECITABINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International N.V. | Dacogen | decitabine | EMEA/H/C/002221 Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy. |
Authorised | no | no | yes | 2012-09-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
