Suppliers and packagers for clindesse

clindesse

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793	NDA	Padagis Israel Pharmaceuticals Ltd	45802-042-01	1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATOR	2015-07-03
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793	NDA	Padagis Israel Pharmaceuticals Ltd	45802-042-02	1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATOR	2015-07-03

CLINDESSE (clindamycin phosphate) Supplier and IP/Regulatory Landscape: Who Manufactures, Sources, and Partners for the Vaginal Foam

Last updated: June 6, 2026

Executive summary CLINDESSE is a branded clindamycin phosphate vaginal foam (0.5% w/v; once-daily for 3 days). The supply chain is anchored by (1) active pharmaceutical ingredient (API) production and formulation into a metered-foam device, (2) aerosol/propellant packaging and filling, and (3) regulatory release by the listed manufacturer of record for each marketed strength. Identifying the specific named suppliers for CLINDESSE requires cross-referencing the FDA Orange Book manufacturing data (listed drug label applicants and manufacturers), agency drug product databases (NDAs and labeling), and the CMC sections that identify manufacturing sites and contract manufacturers.

What does CLINDESSE consist of, and which supplier categories are involved CLINDESSE is formulated as a clindamycin phosphate vaginal foam using a metered aerosol delivery system. The supplier set typically breaks into three categories:

1. API supplier(s): clindamycin phosphate production and supply to the finished dose manufacturer.
2. Finished-dose manufacturer: formulation, foam generation system integration, and packaging.
3. Packaging and propellant system supplier(s): canister, actuator/valve, and propellant components used in the metered foam.

Which companies supply clindamycin phosphate API for CLINDESSE Clindamycin phosphate API is a generic-grade commodity supplied by multiple manufacturers globally. CLINDESSE’s actual API supplier(s) for commercial lots are not reliably deducible from public labels alone because NDA/CMC outsourcing and lot-level sourcing can change. In practice, “supplier” inquiries for CLINDESSE should be treated as “manufacturers listed for the drug product” (FDA-identified) rather than upstream API firms, unless the firm name is explicitly disclosed in Orange Book manufacturing entries or label sections.

How many manufacturers are listed for CLINDESSE (FDA drug product manufacturing sites) The number of manufacturing sites and firms for CLINDESSE can include:

• Drug substance manufacturers (API) named in limited contexts in public FDA documentation
• Finished drug product manufacturers (formulation, filling, finishing)
• Packaging site(s) responsible for canister/actuator integration and final sterile/non-sterile controls (CLINDESSE is non-sterile)

Public-facing supplier lists should start with FDA Orange Book “Manufacturers” entries for the listed drug product.

What patents protect CLINDESSE, and does IP affect supplier eligibility?

Patent estate structure can affect sourcing and genericization, not the “supplier list” itself. Still, any supplier pursuing alternative production, generics, or authorized generics needs to evaluate:

• Composition of matter (clindamycin derivatives or formulations)
• Method-of-use for vaginal administration regimens
• Formulation patents tied to foam characteristics (metered dosing, excipient system, stability)

How strong is the patent estate for CLINDESSE Clindamycin is longstanding, so the dominant IP risk typically shifts to formulation and method-of-use rather than novel antibacterial chemistry. For a supplier of alternative products, the key is whether an Orange Book-listed patent blocks a 505(b)(2) or ANDA pathway.

What patent expiration dates drive generic or biosimilar risk for clindamycin vaginal foam

As clindamycin vaginal formulations are older, timing risk usually relates to:

• Patent expiration
• Pediatric exclusivity or additional exclusivity (if applicable)
• Orange Book delistings or terminal disclaimers

What is the Orange Book status of CLINDESSE?

Orange Book status is the practical reference point for:

• Patent coverage that can deter ANDA entry
• Exclusivity periods that block generic approval
• Listed drug identity used for manufacturing equivalence

When does CLINDESSE lose exclusivity?

Exclusivity timing depends on the specific CLINDESSE NDA listed drug and whether any exclusivity supplements apply (new chemical entity, new dosage form, patent term extensions, and other exclusivity mechanisms).

What generic entry risks exist for CLINDESSE?

For suppliers, the generic entry risk manifests as:

• Inability to launch until patent and exclusivity barriers clear
• Litigation exposure if Paragraph IV is pursued
• Need for bioequivalence or formulation equivalence if a different foam device is used

What formulation patents are protected by CLINDESSE, and what does that mean for manufacturers?

Foam formulations are often protected by:

• Excipients selection
• Foam stability and rheology
• Metered dose uniformity specifications
• Container-closure system integration

For a manufacturer, these patents translate into constraints on:

• Formulation changes
• Device design
• Fill-finish and stability design space

Which companies are challenging CLINDESSE with ANDAs or Paragraph IV certifications?

Generic challengers are identified in:

• Orange Book patent litigation dockets
• District court filings for Hatch-Waxman disputes
• Settlements impacting authorized generic launch timing

What patent litigation affects CLINDESSE supply chain planning?

If CLINDESSE has active patent challenges, they can influence:

• Whether a supplier is willing to invest in ANDA development
• Whether a supplier expects design-around feasibility
• Whether licensing or settlement agreements constrain manufacturing choices

How does CLINDESSE compare with other clindamycin vaginal products on supply and IP?

CLINDESSE is compared with:

• Other clindamycin vaginal creams/ovules (different dosage forms)
• Other clindamycin formulations with distinct IP and device constraints

Different dosage forms often have different device suppliers and different formulation excipient systems. For an investor or partner, this determines the realistic manufacturing transferability.

---

Key Takeaways

• CLINDESSE’s practical “supplier list” for business planning is driven by FDA-identified manufacturers for the drug product and packaging, then by upstream API sourcing under CMC confidentiality.
• Patent and exclusivity status do not change who can supply CLINDESSE today but do drive whether alternative manufacturers can enter and commercialize.
• The most actionable public route to supplier identification is FDA Orange Book manufacturing entries tied to the CLINDESSE listed drug product.

FAQs

1. Who is the manufacturer of record for CLINDESSE on the FDA label and Orange Book?
2. Do CLINDESSE suppliers differ by canister size, carton count, or container closure configuration?
3. What contract manufacturing steps are typically outsourced for vaginal foams like CLINDESSE?
4. Can an ANDA for clindamycin vaginal foam use the same device supplier as CLINDESSE?
5. What Orange Book patents most commonly block generics for older antibacterial vaginal formulations?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database). https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drugs@FDA: CLINDESSE (clindamycin phosphate vaginal foam). https://www.accessdata.fda.gov/scripts/cder/daf/