Last Updated: June 27, 2026

MEXATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Mexate

A generic version of MEXATE was approved as methotrexate sodium by HIKMA on September 16th, 1986.

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Summary for MEXATE
Recent Clinical Trials for MEXATE

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

SponsorPhase
City of Hope Medical CenterPhase 2
Children's Oncology GroupPhase 2/Phase 3
City of Hope Medical CenterPhase 1

See all MEXATE clinical trials

US Patents and Regulatory Information for MEXATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol MEXATE methotrexate sodium INJECTABLE;INJECTION 086358-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol MEXATE methotrexate sodium INJECTABLE;INJECTION 086358-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol MEXATE methotrexate sodium INJECTABLE;INJECTION 086358-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol MEXATE methotrexate sodium INJECTABLE;INJECTION 086358-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb MEXATE-AQ PRESERVED methotrexate sodium INJECTABLE;INJECTION 089887-001 Apr 14, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers MEXATE-AQ methotrexate sodium INJECTABLE;INJECTION 088760-001 Feb 14, 1985 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: June 25, 2026

Mexate (MEXATE) market dynamics and financial trajectory: pricing, demand drivers, exclusivity, and competitive risk

No complete, accurate market-dynamics or financial-trajectory profile can be produced from the information available in this session.

What is MEXATE and what market segment does it serve?

No determinate answer available.

Which active ingredient, dosage forms, and indication(s) define MEXATE?

No determinate answer available.

How has MEXATE performed commercially: revenue, unit trends, and growth drivers?

No determinate answer available.

What are the key demand drivers for MEXATE (guideline use, payer coverage, patient population)?

No determinate answer available.

What are the key erosion or substitution drivers (generics, branded competition, switching)?

No determinate answer available.

What does payer pricing and net price look like for MEXATE versus peers?

No determinate answer available.

Is MEXATE subject to rebate pressure, tender dynamics, or reference pricing?

No determinate answer available.

When does MEXATE lose exclusivity, and what does that imply for revenue?

No determinate answer available.

What patents protect MEXATE and when do they expire (compound, formulation, method-of-use)?

No determinate answer available.

What is the Orange Book status of MEXATE (listed patents and exclusivity codes)?

No determinate answer available.

When do FDA exclusivities expire (NCE/NDA, pediatric, orphan, 505(b)(2))?

No determinate answer available.

What generic or biosimilar entry risks exist for MEXATE?

No determinate answer available.

Have Paragraph IV challenges been filed for MEXATE, and are settlements controlling launch dates?

No determinate answer available.

What launch scenarios matter most: first-filer date, 180-day exclusivity, and authorized generics?

No determinate answer available.

What litigation affects MEXATE’s competitive timeline?

No determinate answer available.

Which courts, which cases, and what remedies (injunctions, stay terms, entry carve-outs)?

No determinate answer available.

How does MEXATE compare with competing drugs in the same class or indication?

No determinate answer available.

Efficacy, safety, convenience, and formulary positioning

No determinate answer available.

Which companies compete with MEXATE and what is their manufacturing and IP posture?

No determinate answer available.

What manufacturing or supply constraints could change MEXATE’s financial trajectory?

No determinate answer available.

What is the likely 12–36 month financial path for MEXATE under different competition cases?

No determinate answer available.

Base case (no new entry), downside (generic entry), upside (expanded indications or contracting gains)

No determinate answer available.

Key Takeaways

No determinate answer available.

FAQs

No determinate answer available.

References

No cited sources available.

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