Suppliers and packagers for OXYTROL

OXYTROL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351	NDA	Allergan, Inc.	0023-6153-08	8 POUCH in 1 BOX (0023-6153-08) / 1 PATCH in 1 POUCH / 4 d in 1 PATCH	2003-02-26

Suppliers and packagers for OXYTROL

Last updated: June 3, 2026

OxyTrol (oxybutynin) suppliers: who manufactures patches, licenses, and API supply

OxyTrol is a branded oxybutynin transdermal delivery system (TDS). The supply chain is anchored by (1) the labeled drug product manufacturer for the US, (2) the active pharmaceutical ingredient (API) supplier(s) for oxybutynin, and (3) the patch technology and manufacturing contractors used to produce the controlled-release transdermal dosage form.

No complete supplier map can be produced from the information provided in the prompt alone.

Who manufactures OxyTrol patches in the US?

Featured answer: The US labeled manufacturer(s) for OxyTrol must be taken from the FDA label and/or Orange Book listing for the specific dosage strength and NDC.

Where to read the authoritative “listed” manufacturer

• FDA drug label “Manufactured for” / “Distributed by” sections for the specific strength (OxyTrol 3.9 mg/24 hr).
• FDA Orange Book “Applicant” and “Manufacturer” fields for the reference product.

Which companies supply oxybutynin API used for OxyTrol?

Featured answer: API suppliers are not reliably published as a named list in public FDA Orange Book data; API origin is typically handled via DMFs (Drug Master Files) and quality agreements.

What determines API supplier visibility

• Whether oxybutynin API is covered by an FDA DMF that identifies the DMF holder.
• Whether the Orange Book listing or labeling discloses the API manufacturer.

What patch technology suppliers are involved in OxyTrol manufacturing?

Featured answer: Transdermal patch manufacturing usually involves specialized excipient, membrane/adhesive, backing, and controlled-release layer supply, but these “technology” suppliers are often not listed publicly.

How to identify transdermal component suppliers

• Look for named material vendors in manufacturing sites disclosed in inspections or in submissions tied to the dosage form.
• DMF activity for excipients, adhesives, or rate-controlling membranes.

How does OxyTrol supply compare with generic oxybutynin TDS suppliers?

Featured answer: Generics can differ in patch design, adhesive composition, and release kinetics, which affects who qualifies as the supplier for the generic patch and whether they rely on different manufacturing contractors.

Key comparison points

• NDC-level manufacturer for each product
• Patch strength equivalence (3.9 mg/24 hr)
• DMF-backed excipients and release-control materials
• Whether the generic uses the same manufacturing site as the reference product

What is the Orange Book status of OxyTrol and how does it affect supplier selection?

Featured answer: Orange Book status indicates whether exclusivity or listed patents restrict certain entry strategies, which can influence who can obtain authorized manufacturing and supply.

How patent and exclusivity affect supply

• If patents or exclusivity remain in force, generic suppliers may avoid certain formulations or manufacturing methods.
• If exclusivity has expired, additional patch manufacturers and contract manufacturers may enter.

What generic entry risks exist for oxybutynin transdermal systems?

Featured answer: The main risks are formulation-layer and manufacturing process lock-in, plus bioequivalence risk tied to patch delivery performance.

Common risk drivers

• Controlled-release layer composition
• Adhesive system performance and skin compatibility
• Stability and moisture barrier requirements

Which litigation or FDA enforcement actions affect OxyTrol suppliers?

Featured answer: Supplier lists can change when manufacturing sites are swapped due to quality findings, consent decrees, or post-approval changes.

Where supplier-impacting events appear

• FDA inspection outcomes tied to manufacturing sites
• Labeling updates reflecting site changes
• Patent-litigation-driven settlement terms that sometimes include supply arrangements

Key Takeaways

• A defensible OxyTrol supplier answer requires mapping to FDA label and Orange Book listing fields at the NDC/strength level.
• API and transdermal component supplier identities typically surface only through DMFs and quality filings, not through public “supplier” lists.
• Without the specific OxyTrol strength/NDC and the FDA label/Orange Book record inputs, a complete supplier roster cannot be produced.

FAQs

1. How do I find the labeled manufacturer for OxyTrol for a specific NDC?
2. Where can oxybutynin API DMF holders be identified for transdermal products?
3. Do OxyTrol generics use the same transdermal patch contract manufacturers as the reference product?
4. Which FDA databases show manufacturing site changes for transdermal delivery systems?
5. How do Orange Book exclusivity periods influence the timing of generic oxybutynin TDS supply?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-04).
2. FDA Prescribing Information (Label) for OxyTrol (oxybutynin transdermal system). (Accessed 2026-06-04).