DECITABINE Drug Patent Profile
✉ Email this page to a colleague
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, Hetero Labs Ltd Vi, 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 twenty 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DECITABINE?
- What are the global sales for DECITABINE?
- What is Average Wholesale Price for DECITABINE?
Summary for DECITABINE
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 450 |
| Patent Applications: | 3,664 |
| 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 |
|---|---|
| Benjamin Tomlinson | Phase 1/Phase 2 |
| Pamela Munster | Phase 1 |
| University Hospital Tuebingen | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wockhardt Bio Ag | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 209056-001 | Apr 9, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Vi | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 215355-001 | May 10, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 203131-001 | Jul 11, 2013 | AP | 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 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 |
