Share This Page
Suppliers and packagers for anafranil
✉ Email this page to a colleague
anafranil
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | ANAFRANIL | clomipramine hydrochloride | CAPSULE;ORAL | 019906 | NDA | SpecGx LLC | 0406-8806-01 | 100 CAPSULE in 1 BOTTLE (0406-8806-01) | 2015-06-01 |
| Specgx Llc | ANAFRANIL | clomipramine hydrochloride | CAPSULE;ORAL | 019906 | NDA | SpecGx LLC | 0406-8807-01 | 100 CAPSULE in 1 BOTTLE (0406-8807-01) | 2015-06-01 |
| Specgx Llc | ANAFRANIL | clomipramine hydrochloride | CAPSULE;ORAL | 019906 | NDA | SpecGx LLC | 0406-8808-01 | 100 CAPSULE in 1 BOTTLE (0406-8808-01) | 2015-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for anafranil
Anafranil (clomipramine) suppliers: who manufactures, supplies, and sells the drug in key markets
Executive summary: Anafranil is the brand name for clomipramine. Market supply is dominated by Teva (US marketing for some strengths/packaging), with additional contributors that typically include generic manufacturers licensed through FDA approvals and distribution agreements. Anafranil’s ongoing availability is shaped by Orange Book listings and ANDA supply chains rather than a single global supplier.
What follows identifies the supplier landscape at the company level (brand marketer and principal generic entrants) and the commercial/IP drivers that determine which companies can supply clomipramine under current US FDA listings.
Who are the main suppliers of Anafranil (clomipramine) in the US?
Short answer: Teva Pharmaceuticals is a key US marketer/supplier for Anafranil (selected strengths and package configurations), with additional supply coming from generic clomipramine manufacturers under ANDAs that the market can source through distributors and pharmacy wholesalers.
US distribution structure
US “suppliers” typically map to two layers:
- FDA label/marketing entity for the brand product (Anafranil).
- ANDA manufacturers making clomipramine tablets/capsules that wholesalers distribute alongside the brand.
Key company roles
- Brand marketer (Anafranil): Teva Pharmaceuticals (US marketing/availability for certain presentations).
- Generic supply (clomipramine): multiple ANDA holders (market access is determined by Orange Book status and distribution agreements).
Which companies make generic clomipramine that competes with Anafranil?
Short answer: Generic supply is multi-supplier, with ANDA manufacturers producing clomipramine tablets for wholesalers and pharmacy supply chains.
How to interpret “suppliers” for clomipramine
For a commodity-like oral antidepressant, company lists vary by:
- strength (e.g., lower vs higher mg tablets)
- dosage form (tablets)
- packaging (bottles vs blister where applicable)
- specific NDC
- contract manufacturing agreements
In practice, “supplier” lists are best built by FDA NDC-to-manufacturer mapping from Orange Book entries and FDA product databases, then linking those manufacturers to distributor networks.
What is the Orange Book status of Anafranil and what does it imply for supply?
Short answer: Anafranil’s exclusivity and patent estate status (via Orange Book listings) determines whether generics can lawfully enter and how quickly supply becomes fragmented across multiple manufacturers.
Why Orange Book matters for supplier counts
- Patent expirations or loss of exclusivity determine when ANDA approvals can convert to commercial launches.
- If exclusivity blocks additional ANDAs, supply concentrates with fewer authorized sources.
- Once patents/exclusivity clear, the market expands to more NDCs from more manufacturers.
When does Anafranil lose exclusivity, and how does that affect generic entry risks?
Short answer: Generic entry risk is determined by the interaction between:
- Orange Book-listed patent expirations for Anafranil (including formulation and method patents if listed), and
- exclusivity periods and any litigation-driven carve-outs that can delay launches.
Typical scenario for older antidepressants
For older, small-molecule oral drugs like clomipramine, the dominant driver tends to be:
- patent expiration timing and
- the ability of ANDA manufacturers to launch without triggering additional stay events.
This affects whether supply is concentrated or broad.
Do Paragraph IV challenges apply to Anafranil clomipramine?
Short answer: They can, but for older molecules the major supply shifts usually occur around patent expiry and any remaining exclusivities, not novel Paragraph IV campaigns.
Supplier impact
- A successful Paragraph IV challenge can add one or more new commercial suppliers quickly.
- A settlement or court decision can shift timelines and keep supply concentrated among fewer NDC providers.
What formulations are supplied for Anafranil, and does that change the supplier list?
Short answer: Supplier lists can change by strength and presentation even if the active ingredient is the same.
What to segment
- tablet strength
- immediate-release vs any alternate release (if applicable)
- packaging formats
- NDC-specific manufacturers
For procurement, contract terms are often NDC-specific.
Which FDA marketing/label entities are associated with Anafranil clomipramine products?
Short answer: The US label entity for Anafranil is Teva Pharmaceuticals for key presentations, while generic clomipramine is distributed through wholesalers under multiple ANDA-labeled manufacturers.
Procurement relevance
- Hospitals and pharmacy chains purchase by NDC and strength
- Substitute sourcing depends on whether the NDCs map to brand or generic manufacturers
What manufacturing/IP barriers limit new Anafranil supply?
Short answer: For clomipramine, supply barriers are usually less about complex biologic manufacturing and more about:
- regulatory status of specific NDCs
- patent and exclusivity constraints reflected in Orange Book
- ANDA approval status and manufacturing site readiness
Practical bottlenecks
- ANDA quality system and batch release performance
- site GMP compliance and inspection history
- ongoing stability and packaging requirements tied to specific NDCs
Competitive landscape: how many suppliers typically provide clomipramine vs Anafranil brand?
Short answer: The brand typically has 1 primary marketer (Teva), while generics usually have multiple ANDA manufacturers for the same strength, producing a multi-supplier competitive field.
What drives supplier count
- number of ANDA holders
- time since last Orange Book exclusivity expiry
- distributor contracting and pharmacy stocking behavior
Revenue and distribution exposure: where do Anafranil supply disruptions matter most?
Short answer: Supply disruptions matter most in:
- long-term antidepressant continuity (chronic use)
- formulary maintenance for fixed-strength regimens
- institutional procurement that locks in NDCs or specific manufacturers
Procurement risk vector
If a chain contracts with a limited set of NDC sources, loss of one manufacturer can drive rapid substitution or backorder risk.
Key Takeaways
- Anafranil is clomipramine, an oral small-molecule antidepressant with supply shaped by FDA listings and ANDA competition.
- Teva Pharmaceuticals is a principal US brand marketer/supplier for Anafranil for key presentations.
- The broader market supplier base is multi-manufacturer generic clomipramine driven by ANDA holders and NDC-level manufacturing assignments.
- Orange Book status governs the timing and breadth of generic entry, which in turn determines how many suppliers can profitably supply each strength and presentation.
- For procurement and litigation watch, focus on NDC-to-manufacturer mapping and any Orange Book-listed patents/exclusivities tied to those presentations.
FAQs
1) Are there multiple suppliers for clomipramine tablets besides Anafranil?
Yes. The clomipramine market typically includes multiple ANDA manufacturers supplying the same strengths under different NDCs.
2) Does the Anafranil supplier list change by strength or NDC?
Yes. The practical supplier for procurement is the manufacturer tied to each NDC, not just the active ingredient.
3) Who typically controls Anafranil distribution at the retail level in the US?
Wholesalers distribute whichever labeled NDCs are available. The branded label entity (notably Teva for Anafranil) and multiple generic manufacturers together define retail availability.
4) Does Orange Book exclusivity affect who can supply clomipramine generics?
Yes. When exclusivity or patents block launches, supply concentrates; once cleared, supplier counts increase via additional ANDAs.
5) What is the fastest way to identify the real-world suppliers for Anafranil?
Build an NDC-level manufacturer list from FDA product and Orange Book sources, then reconcile with wholesaler/NDC availability data used by pharmacies.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Drug Databases (Drugs@FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory
More… ↓
