PURINETHOL Drug Patent Profile
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When do Purinethol patents expire, and when can generic versions of Purinethol launch?
Purinethol is a drug marketed by Stason Pharms and is included in one NDA.
The generic ingredient in PURINETHOL is mercaptopurine. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Purinethol
A generic version of PURINETHOL was approved as mercaptopurine by DR REDDYS LABS SA on February 11th, 2004.
Summary for PURINETHOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 171 |
| Clinical Trials: | 56 |
| Patent Applications: | 104 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in PURINETHOL? | PURINETHOL excipients list |
| DailyMed Link: | PURINETHOL at DailyMed |
Recent Clinical Trials for PURINETHOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | Phase 1 |
| Pfizer | Phase 2 |
| EsPhALL network I-BFM Study Group | Phase 3 |
Pharmacology for PURINETHOL
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PURINETHOL
US Patents and Regulatory Information for PURINETHOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stason Pharms | PURINETHOL | mercaptopurine | TABLET;ORAL | 009053-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 PURINETHOL
| 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 |
