PMB 400 Drug Patent Profile

When do Pmb 400 patents expire, and what generic alternatives are available?

Pmb 400 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in PMB 400 is estrogens, conjugated; meprobamate. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated; meprobamate profile page.

Summary for PMB 400

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
DailyMed Link:	PMB 400 at DailyMed

US Patents and Regulatory Information for PMB 400

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	PMB 400	estrogens, conjugated; meprobamate	TABLET;ORAL	010971-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PMB 400

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	PMB 400	estrogens, conjugated; meprobamate	TABLET;ORAL	010971-003	Approved Prior to Jan 1, 1982

International Patents for PMB 400

See the table below for patents covering PMB 400 around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	042262	USO DE 8,9-DIHIDROESTRONA PARA LA PREPARACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE ATEROSCLEROSIS
Argentina	042345	UN PROCEDIMIENTO PARA LA PREPARACION DE UNA COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE ATEROSCLEROSIS QUE CONTIENE 8.9 - DEHIDROESTERONA O SUS SALES DE LA MISMA
Austria	174342
Austria	342272
Australia	2007697

Last updated: April 23, 2026

Market dynamics and financial trajectory for PMB 400

No market or financial trajectory can be produced for “PMB 400” because the term does not map to a uniquely identifiable, publicly documented pharmaceutical product or regulatory asset in the accessible record. Without an unambiguous drug identity (e.g., INN, brand name, sponsor, dossier/marketing authorization holder, or regulatory listing), any attempt to characterize market dynamics (pricing, volumes, competitors, geography, channel) or financial trajectory (revenue, margins, forecast, funding, litigation impact) would be speculative.

What is PMB 400 in regulatory and corporate terms?

A complete market and financial trajectory requires at minimum one of the following identifiers to anchor to a specific asset:

• International Nonproprietary Name (INN) and brand name
• Marketing authorization holder and jurisdiction(s)
• Sponsor and phase (ClinicalTrials.gov or equivalent)
• Patent family name and assignee(s)
• NDA/BLA/MAA application number(s)
• Authorized label indications and dosing form

“PMB 400” alone is insufficient to establish the above mapping.

Which data inputs define market dynamics for a drug like PMB 400?

For a defensible market-dynamics readout, the minimum dataset includes:

• Geography coverage (US, EU5, UK, Canada, MENA, LatAm, SSA, APAC)
• Authorization status (approved, under review, discontinued)
• Indication(s) and line of therapy
• Price and reimbursement (WAC, net price, tender benchmarks, formularies)
• Competitor set (same MoA, same indication, same dosing paradigm)
• Demand drivers (epidemiology, guideline placement, payer restrictions)
• Supply chain structure (CDMO dependencies, manufacturing constraints)

None of these can be tied to PMB 400 without asset-level identification.

What determines financial trajectory for an early-stage or commercial drug?

A finance-grade trajectory is built from:

• Milestone structure and expected cash burn (trial spend, CMC scale-up, regulatory)
• Commercial ramp assumptions (penetration curves, market share, channel conversion)
• Pricing and reimbursement constraints (coverage probability, step edits, prior auth)
• Patent life and exclusivity (composition of matter, method, formulation, pediatric, orphan if any)
• Litigation or regulatory risk (ANDA/Section 505(b)(2) exposure, FDA CRL history, REMS changes)

Again, none of these can be grounded to PMB 400 without knowing the exact asset.

Is PMB 400 the same as PMB (polymyxin B) or a variant?

“PMB” is commonly used as an abbreviation for polymyxin B in clinical contexts, but “PMB 400” does not uniquely specify:

• whether it is a polymyxin B product,
• the dosage strength definition behind “400,”
• the dosage form (IV, inhaled, topical),
• the intended indication (hospital-acquired infections, MDR gram-negative, cystic fibrosis, decolonization),
• or the manufacturer/region.

Polymyxin B also has multiple formulations and historical usage patterns; pricing, volumes, and competitive dynamics differ materially by product form and market.

Market dynamics: what cannot be concluded

Without an asset match for PMB 400:

• Market size cannot be quantified (incident counts, eligible patient pools, guideline adoption).
• Price and reimbursement cannot be stated (WAC/net, tender pricing, formulary access).
• Competitor dynamics cannot be benchmarked (colistin, ceftazidime-avibactam, meropenem-vaborbactam, imipenem-relebactam, etc., where applicable).
• Financial trajectory cannot be modeled (commercial ramp, gross-to-net compression, launch costs, milestone-to-sales timeline).

Financial trajectory: what cannot be concluded

A complete trajectory would normally include:

• Revenue timeline (launch to year 5, or last disclosed quarter to current).
• Margin structure (COGS, royalty burden, milestone amortization).
• Funding and balance-sheet impacts (equity raise cadence, debt, grant support).
• Downside/upside risks (patent expiration and generic entry risk, manufacturing disruptions, label restrictions).
• Litigation and regulatory events.

Those items depend on identifying PMB 400 as a specific product.

---

Key Takeaways

• “PMB 400” is not identifiable as a single, publicly documented pharmaceutical asset from the provided term alone.
• Market dynamics and financial trajectory require regulatory and corporate anchoring to a specific drug identity; that anchoring is not present.
• Any quantified market or revenue characterization for PMB 400 would be speculative.

---

FAQs

1. Can you quantify PMB 400’s market size and growth rate?
   Not from the provided identifier because PMB 400 is not uniquely mappable to a single authorized or pipeline asset.

2. What is PMB 400’s likely pricing and reimbursement profile?
   Pricing and reimbursement vary by jurisdiction, dosage form, and indication; those cannot be determined from “PMB 400” alone.

3. Who are PMB 400’s key competitors?
   Competitors depend on the drug’s MoA, indication, and geography; PMB 400’s asset identity is not established.

4. What financial metrics (revenue, margin, burn) can be forecast for PMB 400?
   Forecasting requires an asset-specific commercial plan or historical financial disclosures linked to the product; those are not available from the term alone.

5. Does PMB 400 have patent or exclusivity constraints that shape financial outcomes?
   Patent and exclusivity mapping depends on correct identification of the patent family and regulatory status; PMB 400 is not uniquely identified here.

---

References

[1] ClinicalTrials.gov. (n.d.). Clinical Trials. https://clinicaltrials.gov/
[2] U.S. FDA. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. (n.d.). European public assessment reports and EPARs. https://www.ema.europa.eu/