MERCAPTOPURINE - Generic Drug Details
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What are the generic drug sources for mercaptopurine and what is the scope of freedom to operate?
Mercaptopurine
is the generic ingredient in three branded drugs marketed by Nova Labs Ltd, Dr Reddys Labs Sa, Hikma, Mylan, and Stason Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for mercaptopurine. Four suppliers are listed for this compound.
Summary for MERCAPTOPURINE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 10 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 171 |
| Clinical Trials: | 245 |
| Patent Applications: | 4,215 |
| Drug Prices: | Drug price trends for MERCAPTOPURINE |
| What excipients (inactive ingredients) are in MERCAPTOPURINE? | MERCAPTOPURINE excipients list |
| DailyMed Link: | MERCAPTOPURINE at DailyMed |
Recent Clinical Trials for MERCAPTOPURINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Phase 1/Phase 2 |
| Amgen | Phase 1/Phase 2 |
| Pediatric Oncology Experimental Therapeutics Investigators' Consortium | Phase 1/Phase 2 |
Pharmacology for MERCAPTOPURINE
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for MERCAPTOPURINE
US Patents and Regulatory Information for MERCAPTOPURINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nova Labs Ltd | PURIXAN | mercaptopurine | SUSPENSION;ORAL | 205919-001 | Apr 28, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Stason Pharms | PURINETHOL | mercaptopurine | TABLET;ORAL | 009053-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040594-001 | Jul 1, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040528-001 | Feb 13, 2004 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Sa | MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040461-001 | Feb 11, 2004 | AB | 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 MERCAPTOPURINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Nova Laboratories Ireland Limited | Xaluprine (previously Mercaptopurine Nova Laboratories) | mercaptopurine | EMEA/H/C/002022 Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. |
Authorised | no | no | no | 2012-03-09 | |
| >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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