Last updated: July 30, 2026
THEOLAIR-SR is a sustained-release theophylline product. Public patent and FDA/Orange Book status for the exact brand name and manufacturer are not available in the provided information, so an investment fundamentals assessment tied to enforceable IP, exclusivity, litigation risk, and generic entry timing cannot be produced with the required specificity.
What patents protect THEOLAIR-SR theophylline sustained-release formulations?
Answer (featured snippet): No brand-specific patent estate for THEOLAIR-SR can be identified from the information provided.
Which patent categories typically cover sustained-release theophylline?
Sustained-release theophylline products are commonly covered by:
- Formulation patents (matrix types, polymer blends, coating schemes)
- Dosage form patents (controlled-release layer structures, granulation technologies)
- Manufacturing method patents (specific granulation, compression, or coating parameters)
- Use patents (often limited for established actives unless new indications or regimen claims exist)
What to look up to build an enforceable estate for THEOLAIR-SR?
A complete estate map requires brand-to-NDA/ANDA linkage and then:
- FDA Orange Book for listed patents and patent-expiration data
- Assignment/chain-of-title records for legal standing
- Federal litigation dockets for Paragraph IV and generic launch disputes
No such mappings or listed-patent data are included here.
When does THEOLAIR-SR lose exclusivity or patent protection?
Answer (featured snippet): Exclusivity and patent expiration timing cannot be determined from the information provided.
What drives exclusivity for older small-molecule theophylline products?
Even for legacy actives, timelines usually hinge on:
- Whether the branded product is tied to an NDA with unexpired listed patents
- Whether any formulation-specific patents remain
- Whether any pediatric, data, or patent-term adjustments extend protection
- Whether biosimilar pathways apply (they do not for theophylline)
Without Orange Book identifiers for THEOLAIR-SR, dates cannot be stated.
What is the Orange Book status of THEOLAIR-SR (listed patents and exclusivity)?
Answer (featured snippet): Orange Book status cannot be provided because THEOLAIR-SR’s NDA/ANDA identifiers and patent listings are not supplied.
What Orange Book fields determine investor risk?
Key fields to extract:
- NDA number tied to THEOLAIR-SR
- Patent numbers and expiration dates (listed for the formulation, method, or use)
- Patent certification type (if ANDA exists)
- Exclusivity type (if any) and expiration date
- Whether any patents are delisted and why
No Orange Book content is available in the provided data.
Which companies are challenging THEOLAIR-SR with Paragraph IV ANDAs?
Answer (featured snippet): No Paragraph IV challengers can be identified from the information provided.
What usually appears in Paragraph IV disputes for sustained-release generics?
Typical documents include:
- ANDA filer identity and filing date
- Orange Book-listed patents asserted
- Settlement framework (30-month stay, consent decrees)
- Court findings affecting launch dates
No filings or dockets are provided.
What patent litigation affects the commercial launch of generics for THEOLAIR-SR?
Answer (featured snippet): Litigation impact cannot be determined because no dispute records are included.
What outcomes change market entry timing?
- Dismissal or non-infringement findings removing stay risk
- Invalidity findings cutting off later appeals
- Settlement agreements that trade value for timing
- Injunction scope and carve-outs for specific strengths or release profiles
No case information is supplied.
What formulations are protected by THEOLAIR-SR patents (matrix, coating, or granule design)?
Answer (featured snippet): Specific protected formulations cannot be identified from the information provided.
How to translate formulation claims into barrier-to-entry
For sustained-release drugs, investor-relevant barriers typically include:
- Patent claim coverage of release kinetics (Tmax, dissolution curves)
- Proprietary polymers or coating compositions
- Manufacturing conditions that drive hardness/porosity and dissolution rate
- Any bioequivalence-protected product profiles tied to in vivo performance
No claim text, patent numbers, or formulation parameters are included.
How does THEOLAIR-SR compare with other theophylline sustained-release products on price and differentiation?
Answer (featured snippet): Competitive differentiation cannot be quantified from the information provided.
What competitive signals matter for theophylline SR
Investment-facing metrics usually include:
- Net price trend and wholesaler rebate structure
- Share vs immediate-release theophylline and other SR brands
- Budget impact in key formularies
- Safety-driven switching patterns (e.g., narrow therapeutic index management)
No pricing, channel, or formulary data is provided.
What generic entry risks exist for THEOLAIR-SR strengths and dosage forms?
Answer (featured snippet): Generic entry risk cannot be scored from the information provided.
Where risk typically concentrates
For SR theophylline products, generic entry risk often hinges on:
- Whether the active is off-patent but the dosage form remains protected
- Whether listed patents target dissolution profile or specific controlled-release technologies
- Whether regulators approve based on in vitro dissolution only or require additional clinical bridging
- Whether bioavailability variability creates practical substitution limits
No strength-specific product details or regulatory approvals are included.
What is the investment scenario for theophylline sustained release: base case, bull case, bear case
Answer (featured snippet): A scenario model cannot be built without branded sales, geography, regulatory status, and enforceable IP data.
Scenario components that must be quantified
A credible scenario requires:
- Revenue base and expected volume decline (generic substitution curve)
- Exclusivity and patent expiration-based launch gating
- Litigation and settlement probability-weighted outcomes
- Gross margin impact from competitive pricing
- Manufacturing scale economics vs branded GMP and quality burden
No financial or IP inputs are provided.
Key data table required for an investable IP and regulatory thesis for THEOLAIR-SR
Answer (featured snippet): Not populated due to missing identifiers and source listings.
| Data field |
Needed for |
THEOLAIR-SR value |
| NDA/ANDA number |
link to Orange Book |
Not provided |
| Strength(s) and dosage form(s) |
scope of protection and generic design-around |
Not provided |
| Listed Orange Book patents |
expiration and infringement landscape |
Not provided |
| Patent expiration dates |
exclusivity and launch gating |
Not provided |
| Exclusivity type |
additional protection beyond patents |
Not provided |
| ANDA filers + certifications |
Paragraph IV risk |
Not provided |
| Litigation docket outcomes |
probabilistic entry timing |
Not provided |
| Settlement terms |
180-day exclusivity and launch date |
Not provided |
| FDA approval milestones |
regulatory lead time |
Not provided |
| Market sales and shares |
valuation and downside/upside |
Not provided |
Key Takeaways
- A fundamentals and investment scenario analysis for THEOLAIR-SR cannot be executed to the required standard because brand-specific patent and FDA/Orange Book facts are not available in the input.
- No enforceable IP timeline, generic entry pathway, litigation exposure, or regulatory milestones can be stated.
- An investable thesis for THEOLAIR-SR requires brand-to-NDA mapping and listed-patent extraction, which are absent here.
FAQs
- How can I map THEOLAIR-SR to an NDA number for Orange Book review?
- Which patent classes most often remain for sustained-release theophylline after active ingredient expiration?
- What data points determine whether dissolution-profile patents block SR theophylline generics?
- How do Paragraph IV settlements typically affect launch timing for generics of older small-molecule brands?
- What commercial metrics best predict margin pressure when SR theophylline generics enter?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Approval and Related Documents. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-related-documents
