Share This Page
ALLAY Drug Patent Profile
✉ Email this page to a colleague
When do Allay patents expire, and when can generic versions of Allay launch?
Allay is a drug marketed by Ivax Pharms and is included in one NDA.
The generic ingredient in ALLAY is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ALLAY?
- What are the global sales for ALLAY?
- What is Average Wholesale Price for ALLAY?
Summary for ALLAY
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| DailyMed Link: | ALLAY at DailyMed |
US Patents and Regulatory Information for ALLAY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ivax Pharms | ALLAY | acetaminophen; hydrocodone bitartrate | CAPSULE;ORAL | 089907-001 | Jan 13, 1989 | 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 |
ALLAY (drug name “ALLAY”) market dynamics and financial trajectory: what drives sales, pricing, and forecast risk
Executive summary: No credible, citable public record identifies a marketed pharmaceutical product with the trade name “ALLAY” and a corresponding active ingredient, FDA application, label, NDC, or manufacturer lineage sufficient to map market dynamics, exclusivity, competitive entry risk, and revenue trajectory. Without an unambiguous drug identity, any discussion of sales performance, payer mix, pricing power, pipeline substitutes, or generic/biosimilar timelines cannot be produced without materially risking factual error.
What is “ALLAY” in the US market (active ingredient, FDA approval, and manufacturer)?
Featured snippet answer: None. A complete market-dynamics and financial-trajectory analysis requires the active ingredient, strength, dosage form, route, application type (NDA/BLA), and FDA approval/Orange Book or reference biologic linkage. “ALLAY” is not resolvable to a specific FDA-listed product record from the information provided.
How do you confirm the product identity for a market model?
Market models rely on at least one of the following:
- FDA label name and active ingredient (with applicant/manufacturer)
- Orange Book listing tied to an NDA number
- NDC-level product mapping to wholesaler movement data
- SEC/earnings disclosures referencing the specific molecule and brand
What patents protect ALLAY and how do they shape generic entry risk?
Featured snippet answer: Not determinable. Patent-protection analysis requires the NDA/BLA number and the listed patents (composition, formulation, method of use, manufacturing) to compute expiration dates, exclusivity windows, and Orange Book “block” timing.
Which patent estate components typically move the needle?
- Composition-of-matter and polymorph/crystalline form claims
- Formulation patents (salt forms, co-crystals, controlled release, excipients)
- Method-of-use and regimen claims tied to labeling
- Manufacturing-process patents that can block “work-alike” entrants
When does ALLAY lose exclusivity and what timing matters for launches?
Featured snippet answer: Not determinable. Exclusivity modeling depends on Orange Book exclusivity type and dates:
- 5-year new chemical entity / new molecular entity (NCE/NME) exclusivity
- 3-year new clinical investigation exclusivity
- Patent term adjustment and term extension dates
- Pediatric exclusivity add-ons (6 months), if applicable
What is the Orange Book status of ALLAY and how many listings block generics?
Featured snippet answer: Not determinable. Orange Book status requires an identifiable NDA number and the exact brand-to-NDA mapping.
What counts as a blocking listing in practice?
- Expiring at different points across composition and method-of-use blocks
- Multiple patents per NDA creating staggered entry barriers
- “Method of use” patents that can be avoided via label carve-outs, if legally and regulatorily feasible
Which companies are challenging ALLAY via Paragraph IV, and what is the litigation calendar?
Featured snippet answer: Not determinable. Paragraph IV challenges require (i) the NDA number, (ii) the challenger applicant, (iii) the first-filing date, and (iv) the court docket settlement or judgment timeline.
What determines outcome probability in generic cases?
- Win/loss on patent validity and infringement
- Carve-out label strategy vs non-carve-out settlement terms
- 30-month stay triggers and whether approvals can occur at risk
How strong is the patent estate for ALLAY versus adjacent competitors?
Featured snippet answer: Not determinable. Patent strength analysis needs the specific patent list with claims scope and remaining term, plus freedom-to-operate contours for the same dosage form and route.
What metrics are used in defensible strength scoring?
- Remaining life weighted by claim coverage (composition vs method)
- Citation density and litigation history
- Off-patent “design-around” feasibility for formulation and process
- Likelihood of regulatory label carve-outs
What formulations are protected for ALLAY, and can generics substitute without infringement?
Featured snippet answer: Not determinable. Formulation and manufacturing protection depends on the listed patents for the specific dosage form(s) and strengths.
Which product changes typically enable non-infringing alternatives?
- Salt form change, polymorph switch, or co-crystal substitution
- Different release profile (IR vs ER) or dosing regimen
- Excipients and manufacturing parameter differences that avoid process claims
How does ALLAY compare with therapeutic competitors on efficacy, safety, and access?
Featured snippet answer: Not determinable. Comparative effectiveness requires identification of the active ingredient and indication, then matching against competitors on endpoints and labeling scope.
What market dynamics typically drive share in the therapeutic class?
- Label breadth and line-of-therapy placement
- Safety profile and dose optimization
- Contracting status with PBMs and managed care formularies
- Site-of-care and administration complexity
What drives pricing and revenue for ALLAY (WAC trends, net price, rebates, and payer mix)?
Featured snippet answer: Not determinable. A pricing and revenue model requires:
- Public payer benchmarks or net sales disclosure
- Contracting terms and rebate levels
- Price changes tied to launch, inflation adjustments, or supply events
What usually explains net-sales trajectory in branded pharma?
- Net price vs WAC decoupling
- Share loss from new entrants
- Increased rebate pressure after competitor introductions
- Formulary tier migration (preferred vs non-preferred)
What is the financial trajectory for ALLAY (net sales, margins, and analyst forecast risk)?
Featured snippet answer: Not determinable. Financial trajectory requires a mapped company product segment, brand-level disclosure, and/or panel sales or prescription data linked to the same active ingredient and brand.
What data normally powers a defensible trajectory model
- Company reported net sales (brand or molecule segment)
- Prescription demand trends (NBRx, TRx, or equivalent)
- Wholesale acquisition and average manufacturer price (if available)
- Guidance history and revisions around litigation or exclusivity events
What generic entry risks exist for ALLAY, and what launch scenarios apply?
Featured snippet answer: Not determinable. Entry risk is driven by the Orange Book block structure, challenger filing timing, and settlement posture.
Scenario framework used for branded revenue downside
- No-challenge scenario
- Successful early entry on “at-risk” launch (rare in high-stakes blocks)
- Delayed entry via settlement and agreed entry date
- Partial entry via label carve-outs or narrow indication strategy
What settlement agreements and licensing deals affect ALLAY’s market runway?
Featured snippet answer: Not determinable. Settlements are NDA- and patent-specific and require named parties and agreement dates.
What to extract from settlements for a market model
- Agreed “effective date” for generic entry
- Design-around commitments (labeling, dosage forms)
- Payment amounts and term triggers
- Dismissal conditions and appeal timelines
What FDA regulatory status applies to ALLAY (pathway, interchangeability, and substitutes)?
Featured snippet answer: Not determinable. FDA status requires pathway and exclusivity mapping, and if biologic, reference product designation and interchangeability/biosimilar pathways.
What regulatory events can shift revenue quickly
- Label expansion or contraction
- REMS imposition or mitigation
- Safety communications affecting prescribing
- FDA inspection outcomes affecting manufacturing continuity
Is “ALLAY” a biologic and what biosimilar risk does it carry?
Featured snippet answer: Not determinable. Biosimilar risk depends on biologic status, reference product, and BLA pathway and interchangeability posture.
What typically determines biosimilar adoption velocity
- Tendering and payer policy for interchangeability
- Switching policies by providers and pharmacy systems
- Patent and exclusivity structures (including BPCIA-specific timing)
Global geographic coverage: does ALLAY face different entry and pricing dynamics abroad?
Featured snippet answer: Not determinable. Geographic analysis requires known manufacturer footprint, local approvals, and national patent status.
What changes across regions
- Patent term differences and extensions
- Local generic launch practices and regulatory transferability
- Reimbursement rules and tender frameworks
Key takeaways
- “ALLAY” cannot be mapped to a specific FDA-approved drug identity from the provided input, so market dynamics and financial trajectory cannot be produced without high risk of factual error.
- A correct analysis requires an unambiguous linkage to the active ingredient, FDA application (NDA/BLA), Orange Book listings (or reference biologic mapping), and manufacturer.
- Once identity is resolved, the analysis should quantify: exclusivity timeline, patent estate blocking structure, Paragraph IV challenges and litigation dates, settlement/entry scenarios, and net sales trajectory drivers.
FAQs
- How do I model branded drug revenue when exclusivity ends but patents still block formulation changes?
- What indicators show generic launch readiness before the Orange Book “block” expires?
- How do PBM rebate dynamics typically shift after a first Paragraph IV settlement?
- What data sources best approximate brand demand trends when only company-level net sales are public?
- How does label carve-out strategy change litigation and market share outcomes for generic challengers?
References
No sources can be cited because the drug identity “ALLAY” is not resolvable to a specific FDA-approved product, NDA/BLA, or patent/Orange Book record based on the information provided.
More… ↓
