Decitabine - Generic Drug Details
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What are the generic sources for decitabine and what is the scope of patent protection?
Decitabine
is the generic ingredient in two branded drugs marketed by Otsuka, 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-one NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for decitabine. Twenty-four suppliers are listed for this compound.
Summary for decitabine
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 21 |
| NDAs: | 21 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 450 |
| Patent Applications: | 6,878 |
| Drug Prices: | Drug price trends 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nivagen Pharms Inc | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 212117-001 | Dec 7, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novast Labs | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 210984-001 | Sep 16, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 205539-001 | Nov 23, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent Pharms Inc | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 207100-001 | Mar 16, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Otsuka | DACOGEN | decitabine | INJECTABLE;INTRAVENOUS | 021790-001 | May 2, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | DECITABINE | decitabine | POWDER;INTRAVENOUS | 205582-001 | Jan 28, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmascience Inc | DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 204607-001 | May 31, 2017 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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