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LIBRELEASE Drug Patent Profile
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When do Librelease patents expire, and when can generic versions of Librelease launch?
Librelease is a drug marketed by Valeant Pharm Intl and is included in one NDA.
The generic ingredient in LIBRELEASE is chlordiazepoxide. There are nine drug master file entries for this compound. Additional details are available on the chlordiazepoxide profile page.
US Patents and Regulatory Information for LIBRELEASE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Pharm Intl | LIBRELEASE | chlordiazepoxide | CAPSULE, EXTENDED RELEASE;ORAL | 017813-001 | Sep 12, 1983 | 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 |
LIBRELEASE (Drug) Investment Scenario and Patent/Regulatory Fundamentals Analysis
Executive summary
LIBRELEASE’s investability depends on (1) whether it has FDA approval and an enforceable US patent estate listed in the Orange Book, (2) the timing of regulatory exclusivity and patent expirations relative to generic or biosimilar entry risk, and (3) whether there are active Paragraph IV or district-court challenges that could force early licensing or accelerate generic entry. Without an identified active ingredient, dosage form, sponsor/manufacturer, and FDA application reference, a fundamentals-based investment scenario cannot be grounded in verifiable patent or regulatory facts.
What is LIBRELEASE and what product are investors underwriting?
A complete investment fundamentals analysis requires tying “LIBRELEASE” to a specific FDA-approved drug product (active ingredient, strength, dosage form, route, applicant/labeler). In the absence of those identifiers, the following core diligence elements cannot be mapped to enforceable IP or regulatory timelines.
Which active ingredient, strength, and dosage form does LIBRELEASE use?
Investment risk is highly formulation-specific for:
- Composition-of-matter patents
- Formulation and release-profile patents (including controlled-release)
- Method-of-use patents
- Device or delivery system patents (if applicable)
Who is the FDA label holder and commercial marketer?
Commercial exposure and licensing strategy depend on:
- NDA/BLA holder (US labeler)
- Manufacturer and contract development and manufacturing organization (CDMO) arrangements
- Distribution geography and payer mix
What is the therapeutic category and target patient population?
Reimbursement and volume ramp drive valuation. Product category also determines:
- Likelihood of exclusivity layers
- Competitive intensity from branded and follow-on products
- Litigation prevalence for the indication class
What patents protect LIBRELEASE in the US, and how strong is the estate?
Featured-snippet answer: A US patent estate is actionable only if there are Orange Book-listed patents tied to the approved product, plus unexpired investigational or continuation patents with clear expiration exposure.
How many Orange Book patents cover LIBRELEASE?
A patent count and claim scope drive both licensing leverage and generic entry probability:
- Composition-of-matter
- Drug product/formulation
- Method-of-use
- Manufacturing/process
Who are the patent assignees and does ownership match the FDA applicant?
Mismatch between:
- Orange Book patent assignee
- NDA/BLA holder
- Corporate parent can change settlement leverage and licensing feasibility.
What is the expiration map for LIBRELEASE’s key US patents?
Investors typically model:
- Earliest composition-of-matter expiration
- Latest drug product/formulation expiration
- Method-of-use expiration
- Any terminal disclaimers that shorten term
- Continuation/CP status for patent family depth
Which claims are most likely to be designed around?
Generic risk spikes when patents are:
- Concentration-of-API or excipient-level changes without non-obvious release mechanics
- Broad method-of-use claims without narrow patient-condition recitations
- Manufacturing-process claims that can be avoided by alternative production routes
When does LIBRELEASE lose exclusivity?
Featured-snippet answer: Exclusivity “loss” is a function of both regulatory exclusivities (market exclusivity, 5/7/3-year frameworks) and patent expirations listed for the specific drug product.
What regulatory exclusivity applies to LIBRELEASE (NDA/BLA exclusivities)?
The exclusivity package is indication- and application-pathway dependent:
- 5-year new chemical entity (NCE) exclusivity (NDA)
- 3-year new clinical investigation exclusivity (NDA)
- 7-year orphan drug exclusivity (if orphan)
- 6-month pediatric exclusivity extensions (if applicable)
- BLA biologics exclusivity frameworks (if applicable)
What is the patent-expiration timeline for LIBRELEASE in the US?
A defensible investment model requires a date-by-date timeline for:
- Patent expiration dates for Orange Book “listed” patents
- Any reexamination or terminal disclaimer effects
- Any litigation stays that delay generic approval
Are there Paragraph IV challenges against LIBRELEASE, and who filed them?
Featured-snippet answer: The investment implication is whether at least one Paragraph IV ANDA filer exists against LIBRELEASE’s Orange Book patents, and whether litigation has produced a settlement or an adjudicated invalidity/non-infringement outcome.
What is the ANDA filer landscape for LIBRELEASE?
Key items for diligence:
- Number of Paragraph IV certifications
- Which patents are challenged (P4 certifications by patent number)
- Whether challengers target “carve-outs” for specific strengths or formulations
What is the litigation posture and venue?
Valuation hinges on:
- Filing dates of suits
- Court district and judge
- Claim construction rulings that narrow infringement theories
- Summary judgment milestones
- Expected “60-day forfeiture” or “automatic stay” outcomes (when applicable)
What settlement terms affect generic launch timing?
Settlements often include:
- Authorized generic terms
- Launch date carve-outs
- Patent license scope limitations
- Non-compete agreements and their enforceability under antitrust frameworks
What is the Orange Book status of LIBRELEASE, and what generic entry risks exist?
Featured-snippet answer: Generic entry risk is highest when the Orange Book list is short, patents are near expiration, or litigation reduces enforceability.
Which patents are listed for each LIBRELEASE strength and dosage form?
Investors model separate entry risk per strength if:
- Different patents cover different strengths
- Separate FDA supplements exist for reformulations
What is the likely regulatory pathway for generics targeting LIBRELEASE?
For small molecules:
- ANDA (bioequivalence)
- Potential “design-around” of formulation or release profile
For complex products:
- Requirements can raise development cost and delay entry
How do formulation and method-of-use patents affect LIBRELEASE generic competitors?
Featured-snippet answer: Formulation and method-of-use patents often create the practical barrier even when composition-of-matter is expiring or narrowed.
What formulations are protected for LIBRELEASE (release profile, excipients, particle engineering)?
Key patent categories to map:
- Controlled-release matrices or coatings
- Solubilizers/surfactants affecting dissolution
- Particle size distribution and solid-state forms (polymorphs, hydrates, amorphous)
- Bioequivalence “hacks” that are still potentially infringing
What clinical endpoints and dosing regimens are covered by method-of-use claims?
Method-of-use patents drive:
- Carve-out designs that preserve generic entry but leave branded use patterns protected
- Risk for label restrictions and REMS-related labeling modifications
How does LIBRELEASE compare with competing drugs in the same indication?
Featured-snippet answer: Competitive positioning impacts net present value through price durability and volume access, even when IP protects.
Which branded and follow-on products compete with LIBRELEASE?
Valuation drivers:
- Segment share and trajectory
- Formulary coverage
- Comparative safety/tolerability profile (real-world data)
- Uptake against competing generics or biosimilars (if applicable)
How does LIBRELEASE’s delivery system compare with rivals?
If LIBRELEASE is controlled-release or specialized delivery:
- Differentiation can reduce generic substitutability
- Formulation patents add time barriers
What FDA status does LIBRELEASE have, and what milestones matter for investors?
Featured-snippet answer: The investment view depends on whether LIBRELEASE has a current, marketing-ready label with defined manufacturing specs, and whether new supplements are pending.
Is LIBRELEASE launched and how stable is manufacturing/labeling?
Investors diligence:
- Drug substance and drug product manufacturing site approvals
- Label revisions affecting safety or dosing
- Supply continuity and batch consistency
Are there line extensions or supplemental NDAs that extend exclusivity?
Line extensions can extend practical exclusivity through:
- Additional patents covering new strengths, regimens, or delivery forms
- New clinical investigation exclusivity (for NDA frameworks)
What manufacturing and IP barriers could block generic or biosimilar launches of LIBRELEASE?
Featured-snippet answer: Barriers are strongest where patents cover manufacturing/process and controlled-release performance targets.
What process patents or analytical method patents exist for LIBRELEASE?
These can obstruct:
- Alternative manufacturing routes
- Dissolution profile matching
- Quality system replication and method transfer
Do regulatory requirements create additional development risk?
Even without IP, generic development can be delayed by:
- BE study complexity
- Switch from fasting to fed state requirements
- Narrow therapeutic index dynamics (if applicable)
Key Takeaways
- A fundamentals-based investment scenario for LIBRELEASE requires mapping the product to a specific FDA-approved drug identity and Orange Book patent list.
- The core valuation drivers are patent expiration timing, regulatory exclusivity layers, and the existence and status of Paragraph IV litigation.
- Formulation and method-of-use patents typically determine practical generic entry risk even when composition-of-matter patents are expiring.
- Without an identifiable active ingredient/product mapping for LIBRELEASE, no verified Orange Book/patent/ANDA litigation timeline can be produced for investment decisioning.
FAQs
- How do investors model generic launch timing when multiple LIBRELEASE strengths have different listed patents?
- What do settlements typically include when Paragraph IV ANDAs challenge Orange Book patents tied to a branded controlled-release product?
- How does pediatric exclusivity affect the effective launch window for generics facing LIBRELEASE patent protection?
- What patent claim types are most vulnerable to design-around for generics targeting drug-product release characteristics?
- How should investors assess whether a line extension of a branded drug meaningfully extends enforceable exclusivity versus only extending commercial labeling?
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