Suppliers and packagers for generic pharmaceutical drug: ENSIFENTRINE

ENSIFENTRINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389	NDA	MERCK SHARP & DOHME LLC	83034-003-60	60 POUCH in 1 CARTON (83034-003-60) / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE	2024-06-26
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389	NDA	MERCK SHARP & DOHME LLC	83034-003-65	60 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE	2024-06-26

Ensifentrine drug suppliers: Who makes the API and finished drug, and what do the patent and regulatory records imply for procurement?

Last updated: May 23, 2026

Executive summary: Reliable public supplier detail for ensifentrine is limited because the API and finished-dose supply chain typically sits behind confidential manufacturing agreements and the standard FDA public record (Orange Book, labels, and most inspection databases) does not enumerate commercial-grade vendor lists. The most defensible sourcing conclusions come from (1) FDA labeling for the marketed product, (2) corporate disclosures tied to the New Drug Application (NDA) and contract manufacturing, and (3) patent assignees that identify where manufacturing know-how is controlled. Without those specific FDA-label/vendor citations and corresponding patent assignee/manufacturer mapping, vendor-ready procurement lists cannot be produced without fabricating names.

Which companies supply ensifentrine API and the finished drug (NDA contract manufacturers)?

Featured answer: Public records rarely name all commercial suppliers of ensifentrine API and drug product. For procurement-grade sourcing, you need the NDA holder’s label and manufacturing section (often lists drug substance and drug product manufacturing sites) plus any linked inspection or application chemistry/manufacturing disclosure references.

What does FDA labeling typically show for ensifentrine drug product manufacturing?

For most NDA-approved small molecules, the FDA label includes:

• “Manufactured for” and “Distributed by” parties (often NDA holder or marketing authorization holder).
• “Manufactured by” entities for drug product.
• Sometimes the drug substance site is not explicit on the consumer label but can appear in detailed application documentation, recent regulatory submissions, or inspection outcomes.

What do corporate disclosures typically reveal for ensifentrine supply?

NDA sponsors usually contract:

• Drug substance manufacture to specialized API producers.
• Drug product manufacture to a CDMO with formulation, fill-finish, and QA release capability. Procurement lists must be traced to those contract award statements. Without the label section text or application manufacturing site list, supplier naming is not defensible.

What patents protect ensifentrine manufacturing, and how do they constrain supplier selection?

Featured answer: Patent protection can restrict suppliers by covering synthetic routes, polymorphs, intermediates, solid-state forms, and drug product compositions. Even if multiple companies can manufacture chemically, patent barriers can force licensing or design-around.

How to use the ensifentrine patent estate to identify likely controlled manufacturing capabilities

The patent estate typically points to:

• Assignees that control the synthetic know-how (route patents).
• Formulation or dosage form patents (tablet/capsule formulation, excipient systems).
• Solid-state and particle engineering patents (crystal form, particle size distributions, solvate/hydrate). Those assignees often correlate with:
• Internal manufacturing capability.
• Named development partners and CMOs in filing histories.
• Later tech transfer and scale-up counterparts.

Which patent categories most directly affect API supplier qualification?

Key constraints for API procurement are usually:

• Process patents: specific reagents, catalysts, temperatures, purification steps.
• Intermediate patents: controlled intermediates can be a bottleneck for alternate suppliers.
• Solid-state form patents: alternate crystal forms can be non-infringing only if stability and bioavailability requirements are met.

What is the Orange Book status of ensifentrine, and does it list drug product manufacturing partners?

Featured answer: The Orange Book lists approved drug products, active ingredients, dosage forms, strengths, and the patent/exclusivity information. It does not normally serve as a complete supplier directory.

Does Orange Book listing provide a supplier procurement map?

Orange Book data can help identify:

• The NDA number and label holder.
• Patent numbers and patent owners. But it usually does not list:
• All API suppliers.
• All CDMO manufacturing sites.
• Commercial vendor substitutions post-approval.

When does ensifentrine lose exclusivity, and when does generic or biosimilar sourcing become practical?

Featured answer: Exclusivity timing drives supplier economics more than engineering feasibility. API CDMOs often won’t invest in a bioequivalent supply chain until you have a clear generic launch or licensed manufacturing window.

What exclusivity signals determine timing?

For small molecules, the relevant triggers are:

• Patent expiry dates (composition of matter, formulation, method-of-use where applicable).
• Regulatory exclusivity (New Chemical Entity and other exclusivity types where applicable).
• Entry pathways: ANDA filing and Paragraph IV timing.

Are there Paragraph IV challenges for ensifentrine, and which applicants could qualify as future suppliers?

Featured answer: Paragraph IV filers are often the closest public proxy for near-term generic supply. Their ANDA chemistry and manufacturing submissions indicate sourcing feasibility and sometimes identify API suppliers via manufacturing lists.

How Paragraph IV applicants connect to supplier risk and procurement planning

• Filing companies may not manufacture directly, but their ANDA manufacturing sites and listed suppliers become the key procurement targets.
• Litigation outcomes can determine whether those applicants obtain market access and whether their CDMO relationships become reliable supply sources.

How many different suppliers can realistically produce ensifentrine API without licensing?

Featured answer: The number depends on patent scope and whether design-around is available.

• If process and solid-state patents are broad, few suppliers can produce without a license.
• If patents are narrow to specific intermediates or forms, more suppliers may qualify with non-infringing routes.

What procurement teams should look for in supplier dossiers

When supplier count is constrained, buyers typically require:

• DMF or ASMF linkages where applicable (drug substance).
• CoA and batch release analytics for identity, assay, residuals, and polymorph/particle specs.
• Validation evidence for the route and solid-state profile.
• Regulatory history tied to the same form and specification.

How does ensifentrine formulation IP affect CDMO and fill-finish supplier selection?

Featured answer: If formulation patents cover composition, polymorph, or dissolution behavior, CDMOs may need license rights or must use a specific formulation recipe and control strategy.

What drug product attributes trigger formulation patent sensitivity

• Excipients and their ratios.
• Film coating systems and release profiles.
• Solid-state form and dissolution specifications.
• Manufacturing parameters tied to bioavailability.

Which geographic supplier regions reduce patent and regulatory risk for ensifentrine manufacturing?

Featured answer: Geographic diversification mostly reduces operational risk (capacity, logistics, tariffs) but does not remove patent risk for sales into the U.S. market. Patent risk is tied to U.S. commercial conduct and regulatory approvals, not the raw material origin.

What matters more than geography for risk

• Whether the supplier route is non-infringing.
• Whether the NDA/ANDA specification matches the protected form.
• Whether the supplier has regulatory acceptance and validated analytics.

Key takeaways

• Public-facing sources do not provide a complete, procurement-grade supplier list for ensifentrine API and finished drug without tying to NDA label manufacturing sections and patent assignee-linked manufacturing entities.
• Supplier selection is constrained more by ensifentrine’s patent estate (process, solid-state, formulation) than by simple chemical synthesis capability.
• The most actionable sourcing path is vendor identification through (1) the marketed product’s FDA label manufacturing section and (2) patent owner-linked development and manufacturing counterparts, then validating through DMF/ASMF and batch documentation.

FAQs

1. Does ensifentrine have multiple approved drug products (strengths/dosage forms) that imply different manufacturing partners?
2. Can an ANDA supplier use a different solid-state form of ensifentrine without violating patents?
3. Do DMFs for ensifentrine API list specific manufacturers or only facilities?
4. How do process patents for ensifentrine intermediates affect contract manufacturing qualification?
5. What litigation events would most directly change ensifentrine sourcing availability for generic supply chains?

References (APA)
No sources were provided in the request, and no FDA label/Orange Book/patent records were supplied to cite specific ensifentrine suppliers.