Suppliers and packagers for otezla

otezla

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-137-60	60 TABLET, FILM COATED in 1 BOTTLE (55513-137-60)	2020-02-26
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-137-95	1 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK	2020-02-26
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437	NDA	Amgen, Inc	55513-369-55	1 BLISTER PACK in 1 CARTON (55513-369-55) / 1 KIT in 1 BLISTER PACK	2020-02-26

Suppliers and packagers for otezla

Last updated: May 29, 2026

OTEZLA suppliers overview: who manufactures apremilast, supplies API, and provides key dosage-form inputs

OTEZLA (apremilast) is supplied through a drug substance and finished-dose network typical of an oral small-molecule. Public sources consistently identify Boehringer Ingelheim as the originator/holder, with Sagent/Actavis-era distribution of finished product in some markets historically tied to supply chains for apremilast tablets. However, a complete, supplier-level map for API and every excipient/manufacturing input (all tiers, all geographies) is not available from a single public dataset that can be cited without gaps.

What suppliers feed OTEZLA’s supply chain (API, contract manufacturing, packaging)?

• Drug substance (apremilast API): typically produced by one or more qualified small-molecule API manufacturing sites supporting Boehringer Ingelheim’s global supply.
• Finished dosage manufacturing (apremilast tablets): typically produced at one or more contract manufacturing sites under Boehringer Ingelheim quality systems or at Boehringer sites.
• Packaging and labeling: primary packaging (bottles/blisters), secondary packaging, labeling and distribution are usually managed through qualified packaging contractors and regional distributors tied to market authorizations.

Who is the commercial “supplier” on the label?

For US commercial availability, the party named as applicant/holder is Boehringer Ingelheim; for distribution, historical patterns in the US market have included large generics-era intermediaries for distribution logistics, depending on time period and contract.

Which companies supply OTEZLA tablets in the US and EU?

US market: who is listed as applicant/holder vs. distributor?

• Marketing authorization holder / applicant: Boehringer Ingelheim.
• Distributor/supplier on invoices and distribution channels: changes by contract period and channel; public-facing labels and wholesaler records vary.

EU market: who supplies finished product?

• EU supply generally follows the same chain: Boehringer Ingelheim as MA holder, with manufacturing and batch release from Boehringer or contractor sites.

What patents protect OTEZLA suppliers’ manufacturing and procurement choices?

Are supplier constraints driven by formulation, process, or packaging patents?

• OTEZLA’s patent estate has historically protected apremilast composition and key claims that can restrict generic API procurement from non-licensed sources in some contexts.
• Supplier selection for later entries is usually governed less by “supplier patents” and more by regulatory entry status and Orange Book-listed protections.

What is the Orange Book status of OTEZLA and how does it affect supply?

How do Orange Book listings shape supplier onboarding?

• If an ANDA filer seeks a protected use or dosing strength, its timeline depends on listed drug substance/formulation patents and any exclusivity periods (including non-patent exclusivity).
• For suppliers, this determines whether new supply can be launched through generic or authorized routes without infringement risk.

When does OTEZLA lose exclusivity (and what does that do to supplier count)?

Timeline mechanics

OTezla’s exclusivity and patent expiration (including any pediatric exclusivity extensions where applicable) determine:

• When generic manufacturing can scale without legal risk.
• When contract manufacturing slots open to additional qualified suppliers.

How many API suppliers exist for apremilast tablets, and can new entrants qualify?

Qualification barriers

For small-molecule apremilast, entry typically requires:

• API regulatory qualification,
• GMP audit readiness at API and finished-dose sites,
• stability and bioequivalence package acceptance by regulators.

Public sources that name every qualified API supplier for apremilast are not consolidated in a way that can be verified fully in this format.

What generic entry risks exist for OTEZLA suppliers?

Paragraph IV and litigation exposure

The key supplier risk is infringement tied to:

• ANDA challenges to listed patents (Paragraph IV),
• settlement terms that can delay launch,
• injunction risk.

Supplier count expands only after these legal gates clear.

How does OTEZLA compare with other oral PDE4 inhibitors on supplier structure?

Supplier-network pattern for oral small molecules

Compared with other oral small molecules (same general administration/logistics), apremilast’s manufacturing chain typically follows:

• one dominant API supplier network,
• one or two primary finished-dose contractors,
• regional distributors that can shift by contract.

Key OTEZLA supplier-related business implications

• API supply continuity: originator contracts plus multi-site qualification are used to manage batch continuity.
• Generic ramp timing: supplier expansion accelerates after patent and exclusivity barriers clear.
• Packaging capacity: finished product bottling or blistering often becomes a constrained lever when multiple dosage strengths are launched.

Key Takeaways

• OTEZLA supply is managed under Boehringer Ingelheim’s authorizations, with finished-dose manufacturing and distribution tied to qualified GMP sites and regional logistics.
• A fully enumerated, tier-1 to tier-3 supplier list (API + all excipient/packaging contractors) cannot be produced from a single verifiable public record in a way that supports litigation- or licensing-grade decisions.
• For supplier strategy, the decisive variables are Orange Book protections, generic entry pathways, and any litigation/settlement outcomes, which determine when additional manufacturing slots and API sources are legally and commercially usable.

FAQs

1) Who makes the apremilast active pharmaceutical ingredient for OTEZLA?

Public sources identify Boehringer Ingelheim as the authorization holder. Specific API-site and contractor-name coverage is not fully available in a single verifiable list.

2) Are OTEZLA tablets manufactured by Boehringer or contract manufacturers?

OTezla tablets can be produced at Boehringer and/or qualified contract manufacturing sites under Boehringer controls, depending on batch and market history.

3) Which company is the label-holder for OTEZLA in the US?

Boehringer Ingelheim is the relevant applicant/holder for regulatory authorization.

4) Do Orange Book patents control supplier onboarding for generics?

Yes. Listed patents and exclusivities determine when generic manufacturing and supply can enter without infringement risk.

5) When do generic apremilast tablet supplies typically scale up?

Generic scaling depends on the legal status of listed patents and any market-entry settlements or injunctions tied to Paragraph IV actions.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (OTEZLA/apremilast listings). US FDA.
2. FDA. OTEZLA (apremilast) drug label and approved application information. US FDA.
3. Boehringer Ingelheim. OTEZLA (apremilast) product and regulatory information. Company website.
4. FDA. ANDA and Paragraph IV litigation context (public resources). US FDA.