DACOGEN Drug Patent Profile
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Which patents cover Dacogen, and what generic alternatives are available?
Dacogen is a drug marketed by Otsuka and is included in one NDA.
The generic ingredient in DACOGEN 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 Dacogen
A generic version of DACOGEN was approved as decitabine by DR REDDYS on July 11th, 2013.
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Questions you can ask:
- What is the 5 year forecast for DACOGEN?
- What are the global sales for DACOGEN?
- What is Average Wholesale Price for DACOGEN?
Summary for DACOGEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 136 |
| Patent Applications: | 3,664 |
| Drug Prices: | Drug price information for DACOGEN |
| What excipients (inactive ingredients) are in DACOGEN? | DACOGEN excipients list |
| DailyMed Link: | DACOGEN at DailyMed |
Recent Clinical Trials for DACOGEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital Tuebingen | Phase 2 |
| Franziska Wachter | Phase 2 |
| Harvard Clinical and Translational Science Center (Harvard Catalyst) | Phase 2 |
US Patents and Regulatory Information for DACOGEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka | DACOGEN | decitabine | INJECTABLE;INTRAVENOUS | 021790-001 | May 2, 2006 | DISCN | Yes | 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 DACOGEN
| 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 |
