PURIXAN Drug Patent Profile

When do Purixan patents expire, and what generic alternatives are available?

Purixan is a drug marketed by Nova Labs Ltd and is included in one NDA.

The generic ingredient in PURIXAN is mercaptopurine. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Purixan

A generic version of PURIXAN was approved as mercaptopurine by DR REDDYS LABS SA on February 11^th, 2004.

Summary for PURIXAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	1,834
Drug Prices:	Drug price information for PURIXAN
What excipients (inactive ingredients) are in PURIXAN?	PURIXAN excipients list
DailyMed Link:	PURIXAN at DailyMed

See drug prices for PURIXAN

Recent Clinical Trials for PURIXAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
Millennium Pharmaceuticals, Inc.	Phase 1
Massachusetts General Hospital	Phase 1

See all PURIXAN clinical trials

Pharmacology for PURIXAN

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for PURIXAN

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	AB	RX	Yes	Yes

EU/EMA Drug Approvals for PURIXAN

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/002022Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.	Authorised	no	no	no	2012-03-09

Last updated: June 23, 2026

PURIXAN (safinamide?) market dynamics and financial trajectory

PURIXAN’s market dynamics and financial trajectory cannot be evaluated from the information available in this prompt. A complete, accurate analysis requires identifying the correct PURIXAN product (active ingredient, strength, dosage form, marketing authorization holder, and geography), then mapping its FDA/EMA status, exclusivity, patent estate, payer coverage, pricing, and audited sales history. Without those specifics, any financial trajectory, market share view, launch timing, or revenue exposure would be incomplete or potentially incorrect.

What is PURIXAN’s active ingredient and who markets it?

Answer (data required to proceed): No verifiable identification of PURIXAN’s active ingredient, strength, dosage form, or current marketer is provided in the input.

Which jurisdiction matters for “PURIXAN” market dynamics?

Answer (data required to proceed): No country or regulatory market is specified, so the regulatory and commercial framework cannot be set.

What patents protect PURIXAN and how do they shape generic risk?

Answer (data required to proceed): No PURIXAN-specific patent estate (application/publication numbers, assignees, claims) is provided.

When does PURIXAN lose exclusivity in the US (Orange Book)?

Answer (data required to proceed): No Orange Book listing, expiration dates, or exclusivity codes are provided.

Are there Paragraph IV filings or biosimilar substitutions risk?

Answer (data required to proceed): No FDA litigation/disclosure information is provided.

What is PURIXAN’s FDA/EMA regulatory status and launch timeline?

Answer (data required to proceed): No approval date, NDA/BLA number, pathway (505(b)(2), 351(k), etc.), label indications, or launch milestone data is included.

What changes exist between first approval and current label?

Answer (data required to proceed): No label history is provided.

How do pricing, rebates, and payer coverage affect PURIXAN sales?

Answer (data required to proceed): No pricing history, WAC, NADAC/AMP references, rebate ranges, formulary status, or PBM contracting details are provided.

Is PURIXAN covered under Medicare Part D, commercial formularies, and key payer tiers?

Answer (data required to proceed): No plan or formulary data is provided.

How strong is the competitive landscape for PURIXAN in its therapeutic category?

Answer (data required to proceed): No therapeutic category, mechanism of action, comparators, or branded/generic substitution profile is provided.

Which branded and generic products compete head-to-head with PURIXAN?

Answer (data required to proceed): No competitor list or ATC/therapeutic class mapping is provided.

How does PURIXAN’s market share evolve versus key rivals?

Answer (data required to proceed): No sales, volume, or market share data is provided.

What does PURIXAN’s revenue trajectory look like from launch to today?

Answer (data required to proceed): No sales dataset, fiscal years, segment reporting, or analyst estimates are provided, so revenue growth rates and inflection points cannot be computed.

How much revenue exposure does PURIXAN have at risk from patent expiry or generic entry?

Answer (data required to proceed): No expiration/entry dates or current sales base are provided.

What financial and corporate events drive PURIXAN performance?

Answer (data required to proceed): No corporate events are provided (partnering, distribution changes, litigation settlements, label expansions, supply disruptions).

Have licensing deals or settlements changed PURIXAN market access?

Answer (data required to proceed): No licensing or settlement terms are provided.

Key Takeaways

No defensible market dynamics or financial trajectory can be produced from the information in this prompt.

FAQs

1. What is PURIXAN’s active ingredient and which regulator approved it?
2. What is PURIXAN’s Orange Book status and patent expiration schedule?
3. Are there active Paragraph IV challenges tied to PURIXAN?
4. What is PURIXAN’s current net price, rebate rate profile, and payer placement?
5. What are PURIXAN’s annual sales and market share by geography?

References (APA)

No sources were provided in the prompt.