Last Updated: August 9, 2026

THEOPHYL-225 Drug Patent Profile


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Which patents cover Theophyl-225, and what generic alternatives are available?

Theophyl-225 is a drug marketed by Ortho Mcneil Pharm and is included in two NDAs.

The generic ingredient in THEOPHYL-225 is theophylline. There are thirty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Theophyl-225

A generic version of THEOPHYL-225 was approved as theophylline by RHODES PHARMS on September 1st, 1982.

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Summary for THEOPHYL-225

US Patents and Regulatory Information for THEOPHYL-225

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm THEOPHYL-225 theophylline ELIXIR;ORAL 086485-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ortho Mcneil Pharm THEOPHYL-225 theophylline TABLET;ORAL 084726-001 Approved Prior to Jan 1, 1982 DISCN No 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: July 24, 2026

THEOPHYL-225 market dynamics and financial trajectory: revenue drivers, pricing pressure, and IP-linked launch timelines

No complete, verifiable public profile for “THEOPHYL-225” as an approved pharmaceutical product, active ingredient, or named program was provided in the prompt. Without that, market and financial trajectory, including pricing dynamics, revenue exposure, competitors, FDA status, and patent risk, cannot be produced accurately.

What is THEOPHYL-225’s commercial status and where does it sit on the FDA development path?

Answer (required for market modeling): Cannot be determined from the provided input.

What FDA pathway does THEOPHYL-225 use?

Cannot be determined from the provided input.

Is THEOPHYL-225 approved in the US or under review?

Cannot be determined from the provided input.

Are there FDA labels, NDCs, or publicly reported sales for THEOPHYL-225?

Cannot be determined from the provided input.

How do market dynamics shape THEOPHYL-225 pricing, reimbursement, and uptake?

Answer: Cannot be determined from the provided input.

What is the pricing anchor versus current-of-care comparators?

Cannot be determined from the provided input.

How fast does uptake typically ramp for comparable therapies in this indication?

Cannot be determined from the provided input.

What payer dynamics matter most (step edits, PA criteria, MOUs, SPA coverage)?

Cannot be determined from the provided input.

What is the patent and exclusivity timeline for THEOPHYL-225, and how does it affect financial trajectory?

Answer: Cannot be determined from the provided input.

What patents protect THEOPHYL-225 (composition, formulation, method of use, manufacturing)?

Cannot be determined from the provided input.

When does THEOPHYL-225 lose exclusivity (Orange Book exclusivities, data exclusivity, patent expiry)?

Cannot be determined from the provided input.

What paragraph IV or biosimilar risk exists for THEOPHYL-225?

Cannot be determined from the provided input.

How strong is the competitive landscape around THEOPHYL-225 (generics, rivals, and next-gen entrants)?

Answer: Cannot be determined from the provided input.

Which products compete head-to-head with THEOPHYL-225 and what are their market shares?

Cannot be determined from the provided input.

How does pipeline intensity affect share stability and pricing power?

Cannot be determined from the provided input.

What is the risk of rapid substitution after launch for THEOPHYL-225?

Cannot be determined from the provided input.

What generic entry risks exist for THEOPHYL-225 and what would that mean for revenue?

Answer: Cannot be determined from the provided input.

Are there authorized generics, ANDA filers, or settlement agreements affecting timelines?

Cannot be determined from the provided input.

What is the expected revenue decay curve after first generic approval?

Cannot be determined from the provided input.

What non-IP barriers slow entry (REMS, specialty distribution, formulation lock)?

Cannot be determined from the provided input.

How does THEOPHYL-225 compare financially with similar-stage therapies in the same therapeutic area?

Answer: Cannot be determined from the provided input.

Comparable launch benchmarks (revenue ramp, peak sales, treatment persistence)

Cannot be determined from the provided input.

How do manufacturing and COGS constraints affect margins for THEOPHYL-225?

Cannot be determined from the provided input.

What are the key cost drivers (API, CDMO, sterile fill-finish, cold chain)?

Cannot be determined from the provided input.

What litigation and regulatory events could change THEOPHYL-225’s commercialization trajectory?

Answer: Cannot be determined from the provided input.

What patent suits or FDA exclusivity disputes involve THEOPHYL-225?

Cannot be determined from the provided input.

Any REMS, safety label changes, or manufacturing holds affecting commercialization?

Cannot be determined from the provided input.

Key Takeaways

No market dynamics or financial trajectory can be produced for THEOPHYL-225 from the provided input.

FAQs

  1. Is THEOPHYL-225 an approved drug or an investigational candidate?
    Cannot be determined from the provided input.

  2. Will generics or biosimilars erode THEOPHYL-225 revenue, and when?
    Cannot be determined from the provided input.

  3. What is the expected payer mix and reimbursement pressure for THEOPHYL-225?
    Cannot be determined from the provided input.

  4. What does THEOPHYL-225’s patent estate look like across jurisdictions?
    Cannot be determined from the provided input.

  5. What milestones drive de-risking for THEOPHYL-225 commercialization (FDA label, launch, ramp)?
    Cannot be determined from the provided input.

References

No sources were provided or cited.

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