Last updated: July 5, 2026
SLO-PHYLLIN is a marketed theophylline product (oral, sustained-release). The available data set provided here does not include the product’s NDA/ANDA reference, Orange Book listings, labeled strengths and dosage form specifications, approved manufacturers/labelers, or any associated patent numbers. Without those inputs, a complete and accurate investment fundamentals analysis tied to exclusivity, launch timing, competitive risk, and enforceable IP cannot be produced.
Patent and Exclusivity Fundamentals for SLO-PHYLLIN: What patents protect theophylline sustained-release products and how does exclusivity work?
Which patent types usually protect SLO-PHYLLIN-like theophylline products?
- Formulation patents (composition, solid-state forms, matrix or coating systems for sustained release)
- Method-of-manufacture patents (granulation, compression, coating, encapsulation for controlled release)
- Method-of-use patents (dose regimens, titration methods, specific patient populations)
- Device or process patents (if any specialized delivery mechanism exists for the dosage form)
What is the key investment lever: regulatory exclusivity vs enforceable patents?
- Regulatory exclusivity (new chemical entity, new clinical investigation, etc.) is typically shorter-term and product-label dependent.
- Enforceable patents on Orange Book-listed claims usually dominate generic entry timing.
- For older, widely used actives like theophylline, generic availability is common and the investment profile depends on whether the specific branded dosage form has any remaining Orange Book protections, or if it functions mainly as a brand under competition.
Investment-relevant timeline logic (used to underwrite entry risk)
- Identify the reference listed drug (RLD) and the specific SLO-PHYLLIN NDA/ANDA path.
- Extract all Orange Book patents linked to that product and map each to expiration.
- Determine the earliest possible generic launch date if an abbreviated approval pathway is used and the associated patents are not successfully challenged or are not still enforceable.
- Incorporate potential Paragraph IV litigation and settlement effects, which can delay or accelerate launch dates.
Orange Book Status of SLO-PHYLLIN: What is listed and what does it imply for generic entry?
Featured-snippet answer: No Orange Book listing data for SLO-PHYLLIN is available in the provided material, so the patent-and-expiration map for this product cannot be stated.
How to read Orange Book listings for an investment model
- Patent number
- Patent expiration date
- Patent type (drug substance, drug product, method of use)
- Whether it is listed for the RLD and which strengths/dosage forms it covers
What generic launch risks exist for theophylline sustained-release products?
- If the product is not protected by any remaining Orange Book patents, generic entry typically occurs as soon as the regulatory pathway is available.
- If patents are present, generic entry depends on:
- validity and infringement outcomes
- design-around feasibility (especially for formulation/process claims)
- time-to-approval for the generic ANDA
Paragraph IV Litigation for SLO-PHYLLIN: Which companies challenge and what settlements matter?
Featured-snippet answer: No Paragraph IV filings, litigation dockets, or settlement agreements tied to SLO-PHYLLIN are available in the provided material, so challenge and delay scenarios cannot be quantified.
What to model in a litigation-driven underwriting
- Parties: branded sponsor and ANDA filers
- Claims asserted and patents at issue
- Court outcomes: stay status, final judgments, appellate posture
- Settlement terms: 30-month stay triggers, carve-outs, “no-early-entry” covenants, authorized generic windows
How strong is the patent estate for SLO-PHYLLIN? How many patents cover each strength and dosage form?
Featured-snippet answer: Patent counts and jurisdictional coverage for SLO-PHYLLIN are not available in the provided material, so the strength of the patent estate cannot be scored.
Scoring framework used by investors (data requirements)
- Coverage breadth: number of Orange Book patents per strength
- Claim robustness: whether claims cover core release mechanism vs minor formulation aspects
- Expiration clustering: whether multiple patents expire in a short window
- Litigation history: prior challenges and judicial interpretations
FDA Regulatory Status for SLO-PHYLLIN: What approvals, pathways, and exclusivity apply?
Featured-snippet answer: No FDA approval pathway details (NDA number, ANDA reference, RLD determination, labeling, exclusivity codes) are available in the provided material, so regulatory milestones cannot be stated.
What matters for commercial timing
- Approval date and any exclusivity periods tied to the specific application
- Whether SLO-PHYLLIN is the RLD for its cohort
- Whether the product is subject to REMS or special postmarketing commitments
- Stability and manufacturing scale-up constraints that impact generic competition
Formulation and Method-of-Use Risks: What formulations are protected for sustained-release theophylline?
Featured-snippet answer: No product-specific formulation patent data is available in the provided material.
Typical design-around vectors for generic sustained-release theophylline
- Different matrix polymers or coating systems
- Alternative release kinetics targets and dissolution profiles
- Different manufacturing process parameters that avoid literal claim coverage
Commercial Landscape for SLO-PHYLLIN: Who sells competing theophylline sustained-release products and how does that affect revenue exposure?
Featured-snippet answer: No sales, NDC-level market share, manufacturer/labeler roster, or competitor pricing/coverage data is available in the provided material, so revenue exposure and competitive share shift cannot be quantified.
What investors usually underwrite for legacy bronchodilator/xanthine brands
- Inventory and channel fill dynamics
- Payer formularies and prior authorization patterns
- Generic substitution likelihood by plan type
- Supply continuity and quality systems impacting market access
Manufacturing and IP Barriers: What process IP or CMC issues block generics for SLO-PHYLLIN?
Featured-snippet answer: No CMC/manufacturing-method patent data or facility-specific constraints are available in the provided material.
Key barriers that influence generic timelines
- Patent-protected process steps tied to controlled-release manufacturing
- Regulatory data exclusivity for specific process-related submissions
- Stability constraints requiring specialized equipment or conditions
Investment Bottom Line for SLO-PHYLLIN: What is the actionable scenario?
Featured-snippet answer: An investment scenario cannot be constructed because the necessary inputs for patent-driven exclusivity/entry timing, litigation risk, and regulatory status for SLO-PHYLLIN are not present in the provided material.
Key Takeaways
- SLO-PHYLLIN is a theophylline sustained-release product, but a patent, exclusivity, and litigation-based investment scenario requires Orange Book listing and FDA application details that are not included.
- Without Orange Book patent numbers, expiration dates, and FDA regulatory pathway information, generic entry timing and enforceable-IP strength cannot be evaluated.
- Commercial exposure cannot be underwritten without NDC-level sales/market-share data and competitor roster.
FAQs
- Is SLO-PHYLLIN considered an RLD for theophylline sustained-release, and how does that affect ANDA timing?
- What is the typical Paragraph IV litigation pattern for legacy sustained-release oral bronchodilators like theophylline?
- Do formulation patents usually dominate IP protection for sustained-release theophylline generics, or do method-of-use claims drive enforcement?
- How do dissolution profile requirements influence generic success for controlled-release theophylline tablets/capsules?
- What commercial KPIs best predict near-term brand revenue erosion for older theophylline brands facing generic competition?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-05).
- U.S. Food and Drug Administration. Drugs@FDA. (Accessed 2026-07-05).
