Last Updated: September 28, 2026

VALPIN 50 Drug Patent Profile


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Which patents cover Valpin 50, and when can generic versions of Valpin 50 launch?

Valpin 50 is a drug marketed by Endo Pharms and is included in one NDA.

The generic ingredient in VALPIN 50 is anisotropine methylbromide. There is one drug master file entry for this compound. Additional details are available on the anisotropine methylbromide profile page.

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Summary for VALPIN 50
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 28
Patent Applications: 491
DailyMed Link:VALPIN 50 at DailyMed

US Patents and Regulatory Information for VALPIN 50

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms VALPIN 50 anisotropine methylbromide TABLET;ORAL 013428-001 Approved Prior to Jan 1, 1982 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
Last updated: July 26, 2026

Valpin 50 market dynamics and financial trajectory: sales drivers, pricing, exclusivity risk, and competitive outlook

Valpin 50 is not a uniquely identifiable pharmaceutical asset from the information provided. Without a verifiable mapping to a specific active ingredient, dosage form, strength definition, marketing authorization holder, or an FDA/EMA registry entry, market and financial projections cannot be grounded in primary datasets (Orange Book, EMA EPAR, IQVIA public proxies, company filings, tender data, or payer formularies).

No complete market-dynamics or financial-trajectory analysis can be produced for “VALPIN 50” as written.

What is Valpin 50 and what active ingredient does it contain?

A market-dynamics and financial-trajectory model requires the exact drug identity: active ingredient, salt form (if any), dosage form (tablet/capsule/solution), route (oral/IV), and the reference listed drug (RLD) or marketing authorization in relevant jurisdictions. “Valpin 50” by itself does not provide that linkage.

Which jurisdictions have marketing authorization for Valpin 50?

An exclusivity, pricing, and competitive landscape assessment depends on where Valpin 50 is marketed (US, EU5, UK, Canada, LATAM, MENA, India). “Valpin 50” does not specify coverage.

Is Valpin 50 an originator product, generic, or branded repack?

Financial trajectory diverges sharply depending on whether the brand is protected as an innovator product, a line extension, or a generic brand under a different manufacturer.

What patents protect Valpin 50 and when do they expire?

A patent estate analysis requires at least one of the following: an NDA/ANDA/BLA number, an EPAR/marketing authorization number, an Orange Book listing, or a patent family anchored to the INN and formulation.

Which Orange Book listings apply to Valpin 50 in the US?

Orange Book status determines paragraph IV risk, settlement probability, and likely generic launch timing. No listing can be tied to “Valpin 50” without the drug’s active ingredient and RLD.

How many formulation and method-of-use patents cover Valpin 50?

Formulation and method-of-use coverage drive value-at-risk for brand holders. This cannot be quantified without patent identifiers.

When does Valpin 50 lose exclusivity and what generic entry risks exist?

Exclusivity and generic entry risk depend on regulatory status, patent term, pediatric exclusivity, data exclusivity, and any authorized generics.

Does Valpin 50 face Paragraph IV challenges?

Paragraph IV filings are tracked to specific Orange Book entries. Without the drug identity, there is no basis to enumerate challenges or assess the litigation calendar.

What generic launch scenarios apply to Valpin 50?

Launch scenarios require entry dates, likely challengers, and whether multiple ANDAs are ready at the same time. No verifiable information can be mapped.

What formulations are protected for Valpin 50 and how does that affect pricing?

Pricing power typically depends on differentiation: controlled release vs immediate release, combination vs monotherapy, or unique formulation enabling lower pill burden or improved tolerability.

Is Valpin 50 immediate release or extended release?

Delivery system affects substitutability and payer reimbursement thresholds. “Valpin 50” does not identify the formulation class.

What manufacturing/IP barriers block generic competition?

Manufacturing patents and process controls can slow entry even when composition-of-matter expires. This cannot be assessed without a patent family tied to the product.

What FDA or EMA regulatory status does Valpin 50 have?

Market access and volume trajectory track regulatory pathway and approval timing.

What is the FDA pathway and current approval type?

NDA vs ANDA vs 505(b)(2) and the RLD mapping determine whether the brand is exposed to immediate generic pressure.

What is the EMA status and any withdrawal history?

EPAR timelines and any safety-driven changes affect demand and pricing.

Which companies compete with Valpin 50 and how do their market shares evolve?

A competitor map needs the active ingredient and dosage form so it can be linked to the relevant therapeutic market definition.

How does Valpin 50 compare with other brands or generics in the same class?

Therapeutic-class comparison requires a defined comparator set by INN, strength, and release profile.

Are there authorized generics, bundle contracts, or tender exclusivity agreements?

Tender behavior can dominate unit volumes in several markets. “Valpin 50” does not provide enough information to ground tender or procurement analysis.

Valpin 50 pricing and reimbursement dynamics: what drives net sales?

Net sales depend on list price vs realized price, rebates/discounts, tender pricing, and payer restrictions.

Is Valpin 50 subject to price controls or reference pricing?

Price control regime depends on country, reimbursement status, and therapeutic index.

What do payer policies imply for formulary placement and utilization?

Utilization depends on clinical guidelines and formulary tiers. Drug identity is required to connect to HTA and payer evidence.

Financial trajectory for Valpin 50: revenue outlook, margin pressure, and downside scenarios

A financial model requires historical sales (units and net sales), gross-to-net composition, and guidance from the rights holder or public market data.

What is the historical sales trend for Valpin 50 (units, net sales, growth)?

No sales series can be anchored to “VALPIN 50” without a confirmed company/product identifier.

What is the downside risk from generic erosion and interchangeability?

Generic erosion depends on entry timing, number of entrants, and whether substitution is permitted without prescriber authorization.

Key variables that determine whether Valpin 50 maintains profitability

  • Tender price floor and rebate structure
  • Competitor entry density
  • Formulary tier persistence
  • Any safety updates or restriction changes

Key takeaways

No defensible market-dynamics or financial-trajectory analysis can be produced for “VALPIN 50” without a verifiable mapping to an active ingredient and regulatory product identity.


FAQs

  1. What is Valpin 50’s active ingredient and dosage form?
  2. Is Valpin 50 listed in the FDA Orange Book, and what is its RLD?
  3. Are there any pending Paragraph IV ANDA challenges for Valpin 50?
  4. What competitor generics or brands threaten Valpin 50’s market share?
  5. What reimbursement or price-control regime applies to Valpin 50 in key markets?

References

No sources cited.

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