Last Updated: August 9, 2026

GRIS-PEG Drug Patent Profile


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When do Gris-peg patents expire, and what generic alternatives are available?

Gris-peg is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in GRIS-PEG is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

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Summary for GRIS-PEG
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 45
Patent Applications: 4,150
Drug Prices: Drug price information for GRIS-PEG
What excipients (inactive ingredients) are in GRIS-PEG?GRIS-PEG excipients list
DailyMed Link:GRIS-PEG at DailyMed

US Patents and Regulatory Information for GRIS-PEG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch GRIS-PEG griseofulvin, ultramicrosize TABLET;ORAL 050475-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bausch GRIS-PEG griseofulvin, ultramicrosize TABLET;ORAL 050475-002 Approved Prior to Jan 1, 1982 AB RX 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

GRIS-PEG market dynamics and financial trajectory: pricing, demand drivers, payer access, and competitive/IP exposure

Last updated: June 24, 2026

What is GRIS-PEG and where is it positioned in the market?

GRIS-PEG is not a uniquely identifiable pharmaceutical product name in public regulatory and drug reference sources under that exact brand string. The phrase “GRIS-PEG” is also used as a descriptive term in some contexts involving polymer- or PEG-related delivery systems, which prevents a reliable mapping to a specific active ingredient, FDA/EMA marketing authorization, NDC/EPAR listing, or commercial launch profile.

No market-dynamics and financial-trajectory assessment can be produced with the required level of factual integrity without a verified product identity (drug substance, dosage form, sponsor/MAH, and launch jurisdiction).

What revenue trajectory metrics are available for GRIS-PEG?

No verifiable revenue series, milestone receipts, sales disclosures, or payer/claims datasets can be tied to “GRIS-PEG” as a standalone product based on the information provided. Without a confirmed product-to-ticker mapping (sponsor) and verified commercial status (launched vs. investigational), any revenue trajectory would be speculative.

How do pricing and reimbursement dynamics work for GRIS-PEG?

Pricing and reimbursement depend on the specific granted authorization, NDC/market entry, and payer category (commercial, Medicaid, Medicare Part D, or hospital outpatient). For “GRIS-PEG,” those elements cannot be validated from the information given, so there is no defensible basis to state ASP, WAC, net-to-gross, preferred formulary status, prior authorization controls, or utilization management.

What demand drivers and clinical adoption risks affect GRIS-PEG?

Demand drivers (treatment guidelines placement, line-of-therapy position, biomarker selection, administration setting, and comparative outcomes) require the underlying indication and mechanism. For “GRIS-PEG,” neither is confirmed from the provided prompt, so adoption risk quantification cannot be performed.

What competitive landscape pressures exist for GRIS-PEG?

A credible competitive assessment requires the therapeutic class, comparators, and route of administration. With GRIS-PEG’s active ingredient and indication not identifiable, competitor mapping (same MOA, same patient segment, and similar delivery technology) cannot be executed without risking incorrect attribution.

What is GRIS-PEG’s FDA/EMA regulatory status and how does it shape sales?

Regulatory status drives timeline to approval, label scope, REMS requirements, and post-marketing study obligations. “GRIS-PEG” cannot be reconciled to a specific FDA label or EMA authorization using the provided information, so the regulatory-to-revenue link cannot be quantified.

When does GRIS-PEG face exclusivity expiry or generic/biosimilar entry risk?

Exclusivity and entry risk require a mapped label, Orange Book/EMA data, and patent estate. For “GRIS-PEG,” no validated patent or exclusivity record can be tied to the name as written, so launch-risk and erosion scenarios cannot be supported with hard data.

How does GRIS-PEG compare financially with other PEGylated or GRIS-technology drugs?

Benchmarking requires a defined molecule and indication. Without confirmation of GRIS-PEG’s active ingredient and target population, there is no valid peer set for WAC/ASP comparisons, price erosion timing, or sales-share modeling.

Key Takeaways

  • “GRIS-PEG” cannot be reliably mapped to a specific FDA/EMA-authorized drug, active ingredient, sponsor, or commercial product using the information provided.
  • Without verified product identity, no factual revenue trajectory, pricing/reimbursement profile, competitive landscape, regulatory status, or exclusivity expiry can be stated.
  • Any market dynamics or financial trajectory claims would be non-actionable and potentially incorrect.

FAQs

  1. What does “GRIS-PEG” refer to in drug development?
  2. How can investors validate whether GRIS-PEG is an approved product or investigational program?
  3. Which datasets (Orange Book, EPAR, NDC, Medicare claims, payer formularies) should be used to model drug revenue trajectory?
  4. What factors typically determine net price and reimbursement for PEG-based therapies?
  5. How do patent and exclusivity timelines translate into generic entry risk for small-molecule vs biologic-like drugs?

References

No sources can be cited because the prompt does not provide enough information to verify GRIS-PEG’s exact drug identity in authoritative regulatory databases.

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