MERCAPTOPURINE Drug Patent Profile
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When do Mercaptopurine patents expire, and what generic alternatives are available?
Mercaptopurine is a drug marketed by Dr Reddys Labs Sa, Hikma, and Mylan. and is included in three NDAs.
The generic ingredient in MERCAPTOPURINE is mercaptopurine. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mercaptopurine
A generic version of MERCAPTOPURINE was approved as mercaptopurine by DR REDDYS LABS SA on February 11th, 2004.
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Questions you can ask:
- What is the 5 year forecast for MERCAPTOPURINE?
- What are the global sales for MERCAPTOPURINE?
- What is Average Wholesale Price for MERCAPTOPURINE?
Summary for MERCAPTOPURINE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 171 |
| Clinical Trials: | 245 |
| Patent Applications: | 1,767 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Lucile Packard Children's Hospital Foundation | Phase 1/Phase 2 |
| Stanford University | Phase 1/Phase 2 |
| Amgen | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040461-001 | Feb 11, 2004 | 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 | |||
| Mylan | MERCAPTOPURINE | mercaptopurine | TABLET;ORAL | 040594-001 | Jul 1, 2005 | 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 |
