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CONSTILAC Drug Patent Profile
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Which patents cover Constilac, and when can generic versions of Constilac launch?
Constilac is a drug marketed by Alra and is included in one NDA.
The generic ingredient in CONSTILAC is lactulose. Twenty-two suppliers are listed for this compound. Additional details are available on the lactulose profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Constilac
A generic version of CONSTILAC was approved as lactulose by PHARM ASSOC on July 30th, 1996.
US Patents and Regulatory Information for CONSTILAC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alra | CONSTILAC | lactulose | SOLUTION;ORAL | 071054-001 | Jul 26, 1988 | 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 |
CONSTILAC (CONSTILAC®) Investment Scenario and Patent-Regulatory Fundamentals Analysis
What is CONSTILAC and what commercial drivers matter for investors?
Executive summary: CONSTILAC is positioned as an oral enteral health product with commercially meaningful drivers tied to (1) regulatory pathway status, (2) route and indication clarity, (3) exclusivity anchored in patents, and (4) distribution penetration through institutional and retail channels. The investment case depends primarily on whether CONSTILAC is protected as an NDA/ANDA drug with an Orange Book patent estate or as a non-Orange Book product (which usually compresses generics and lowers long-term pricing power).
What active ingredient(s) and dosage form(s) define CONSTILAC?
No definitive drug substance, strength, dosage form, or label indication is provided in the prompt. Without these core identifiers, the Orange Book, exclusivity, and patent landscape cannot be accurately mapped to CONSTILAC.
What is the regulatory classification investors must anchor to?
The investment fundamentals hinge on whether CONSTILAC is:
- An FDA-approved “drug” with an Orange Book listing (patents, exclusivity, label protections), or
- A dietary supplement/medical nutrition product with no FDA drug patent exclusivity construct.
The prompt does not include FDA product type, NDC, or label details.
What patents protect CONSTILAC and how strong is the patent estate?
Executive summary: A complete, investor-grade patent estate assessment requires the product’s active ingredient, NDA number or reference product, and dosage form. Without those, patent searching cannot be tied to the correct legal and pharmacological entity for CONSTILAC.
How many patents cover CONSTILAC and what types?
A typical investor breakdown for an FDA-listed drug focuses on:
- Composition of matter patents (strongest, often earliest filing)
- Formulation patents (dosage form, excipients, coating, stability)
- Method-of-use patents (indication-specific)
- Process/manufacturing patents (scale-up, purification, crystallization, polymorphs)
- Device/delivery system patents (if applicable)
No patent identifiers, assignees, jurisdictions, or filing dates are provided for CONSTILAC.
Which jurisdictions and assignees matter to licensing value?
High-leverage licensing and litigation outcomes correlate with where protection is filed:
- US: Orange Book leverage, Paragraph IV and Hatch-Waxman timing
- EP/WO: long-term enforcement optionality
- CN/IN: generic manufacturing threat maps No jurisdictional or assignee data is available in the prompt.
When does CONSTILAC lose exclusivity and what are the key expiration dates?
Executive summary: Loss-of-exclusivity timing is anchored to the NDA/BLA reference product’s Orange Book patent expirations and any data exclusivity. The prompt does not identify the FDA reference product, so expiration dates cannot be produced.
What are the typical exclusivity buckets that drive launch timing?
For FDA drugs, investors usually monitor:
- 5-year new chemical entity or new molecular entity exclusivity
- 3-year new clinical investigation exclusivity
- Patent term expiration plus regulatory exclusivity extensions
- Pediatric exclusivity (6 months) if triggered None of these can be mapped to CONSTILAC without FDA identifiers.
What is the paragraph IV challenge risk window for CONSTILAC?
Paragraph IV risk requires:
- Orange Book listing status
- Patent numbers with ATD (active therapeutically equivalent drug) mapping
- Expected ANDA filers and likely Paragraph IV triggers No listing or patent data is included.
What is the Orange Book status of CONSTILAC?
Executive summary: Orange Book status cannot be determined from the provided prompt because CONSTILAC identifiers (NDC, NDA number, sponsor) are missing.
What would investors expect to see if CONSTILAC is an FDA-listed drug?
A functional Orange Book profile typically lists:
- NDA number
- Listed patents with expiration dates
- Patent codes (P, A, B1, B2, C, etc.)
- Exclusivity end date(s)
None of this is present.
Which companies are challenging CONSTILAC and what Paragraph IV litigations exist?
Executive summary: Litigation and generic challenge mapping requires Orange Book patents plus court docket events. No court cases, ANDA filers, or settlement terms are provided for CONSTILAC.
What settlement patterns drive damages and off-ramp economics?
In investor terms, these factors matter:
- “Carve-out” settlements or non-launch covenants
- Agreed design-arounds
- Early-launch permitted dates
- Royalty structures or milestone payments Without any litigation records in the prompt, this cannot be constructed.
What formulations are protected for CONSTILAC and how does that affect generic design-arounds?
Executive summary: Formulation protection is central to sustaining pricing power if composition-of-matter is weak or close to expiry. But the specific dosage form and claimed formulation elements are not supplied for CONSTILAC, so the design-around barrier cannot be evaluated.
What formulation categories would typically be protected?
- Stabilizers and preservatives affecting microbial control
- Buffer systems and pH targets for shelf stability
- Enteric coatings and release profiles
- Osmolality and excipient compositions for gut tolerability No formulation or patent claim details are provided.
Does CONSTILAC have method-of-use patents that protect specific indications?
Executive summary: Method-of-use patents can extend commercial exclusivity even after composition patents expire, but identifying them requires the active ingredient and FDA-labeled indication(s). Neither is provided.
How method-of-use claims change generic exposure
If method-of-use patents cover:
- Dosing regimens (timing and frequency)
- Patient subsets (pediatric, post-antibiotic, disease severity)
- Combination therapies (active ingredient + co-therapeutics) then generic labeling restrictions may persist.
No such claim or indication data is included for CONSTILAC.
How does CONSTILAC compare with competitive alternatives and what is the market differentiation thesis?
Executive summary: Competitive comparisons require the therapeutic category and active ingredient to benchmark against approved drugs, biologics, generics, and OTC/medical nutrition substitutes. The prompt provides no indication or molecule.
What comparison set investors typically build
- Same active ingredient (market-share and pricing dispersion)
- Same therapeutic goal (class comparison)
- Same route (oral, enteral, topical, etc.)
- Similar patient population No comparison basis is specified for CONSTILAC.
What regulatory milestones apply to CONSTILAC and what is the path-to-growth risk?
Executive summary: Regulatory risk is driven by FDA approval status, post-market requirements, labeling changes, and compliance outcomes. The prompt lacks FDA status details.
What investors track for FDA-regulated products
- Initial NDA approval date or OTC listing date
- Changes requiring prior approval supplements
- Inspections, warning letters, or consent decrees
- Manufacturing site changes
- Stability and shelf-life updates No regulatory milestone data is included for CONSTILAC.
Is there biosimilar or biologics competition risk for CONSTILAC?
Executive summary: Biosimilar risk applies only if CONSTILAC is a biologic. The prompt does not identify CONSTILAC as a biologic or provide its therapeutic substance type.
What would trigger biosimilar scrutiny
- Protein/peptide drugs with reference biologics
- FDA BLA and Purple Book listings
- Patent-protected epitope or manufacturing-specific claims No such indicators are provided.
What generic entry risks exist for CONSTILAC and how would a launch likely occur?
Executive summary: Generic entry risk depends on Orange Book patents and FDA approval type. Without Orange Book data, generic entry timing cannot be anchored.
What a worst-case investor scenario requires
For a typical patent-expiry generic scenario, investors look for:
- ATD-listed patent expirations
- Patent expiry sequence (composition vs method vs formulation)
- ANDA submission patterns and launch readiness
- Any “authorized generic” behavior No ANDA, patent, or FDA status information is included for CONSTILAC.
What licensing and partnership economics could attach to CONSTILAC?
Executive summary: Licensing value hinges on defensibility (patents), regulatory exclusivity, and manufacturability. The prompt lacks patent and regulatory identifiers needed to map licensing attractiveness.
Common licensing structures investors underwrite
- Upfront + milestone payments tied to regulatory or sales events
- Royalties on net sales with tiered escalators
- Territory splits and manufacturing supply agreements
- Technology transfer and know-how provisions No business terms, past deals, or sponsors are provided for CONSTILAC.
What do revenue exposure and downside scenarios look like for investors?
Executive summary: Revenue exposure depends on whether CONSTILAC is protected as a branded drug with durable exclusivity or operates in a less defensible category. The prompt does not include any revenue metrics, ownership, channel, or labeling.
What downside triggers matter most
- Patent expiry or loss of exclusivity
- Competitor re-labeling that avoids restrictions
- Supply disruptions from sole-source manufacturers
- FDA enforcement actions
- Margin compression via generic/OTC substitution No such inputs are provided.
Key Takeaways
- An investment-grade fundamentals and patent-regulatory analysis of CONSTILAC requires the drug’s active ingredient, FDA product identifiers (NDA/BLA or NDC), dosage form, and labeled indication.
- Without those identifiers, the Orange Book status, exclusivity timelines, patent estate strength, Paragraph IV risk, and litigation landscape for CONSTILAC cannot be produced in a way that supports R&D, licensing, litigation, regulatory, or investment decisions.
FAQs
- How can I determine CONSTILAC’s Orange Book listing status without an NDA number?
- What patent types (composition, formulation, method-of-use) most often drive generic delay for gut health oral products?
- What is the typical Paragraph IV filing timeline once Orange Book patents approach expiration?
- How do formulation-specific patents influence generic design-around strategies and label acceptance?
- What FDA regulatory events most often cause re-pricing or market-share loss for branded oral products?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA Hatch-Waxman related guidance and exclusivity framework materials. U.S. Food and Drug Administration.
- FDA Purple Book: Lists of Licensed Biological Products. U.S. Food and Drug Administration.
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