Last updated: April 24, 2026
Who manufactures carbidopa/levodopa and what is the supply map?
Carbidopa/levodopa supply in commercial markets comes from (1) brand manufacturers of specific dosage forms (including intestinal gel) and (2) multiple generic manufacturers producing oral tablets and capsules. The highest-leverage supplier positions differ by formulation because “carbidopa/levodopa” is not one product category; it includes multiple release types and delivery systems.
Delivery-system split (where suppliers concentrate)
| Product form |
Typical brand examples |
Supply concentration |
| Immediate-release oral tablets |
Sinemet (carbidopa/levodopa) |
Broad generic bench with multiple FDA-approved ANDA entrants plus brand-maker |
| Immediate-release oral capsules |
Generic carbidopa/levodopa capsules |
Broad ANDA bench |
| Extended/controlled release oral |
Carbidopa/levodopa ER (varies by label) |
Fewer entrants than IR |
| Intestinal gel infusion |
Duopa (carbidopa/levodopa intestinal gel) |
More concentrated; device-and-gel ecosystem |
Which companies dominate the Duopa (carbidopa/levodopa intestinal gel) ecosystem?
Duopa is the key carbidopa/levodopa intestinal gel product. Supplier dynamics depend on the gel and the delivery system. In the US, Duopa is marketed by AbbVie.
Duopa market supplier (gel product)
- AbbVie: Duopa (carbidopa and levodopa intestinal gel) [1]
Who supplies oral carbidopa/levodopa tablets and capsules?
Oral carbidopa/levodopa is widely genericized. In the US, the practical supplier list is the set of FDA-approved ANDA holders for carbidopa/levodopa oral products plus the original brand manufacturer for tablets/capsules where still marketed.
Brand supply anchor (oral IR tablets)
- Merck (MSD): Sinemet (carbidopa and levodopa) in US branding history; specific marketing may vary by territory and label ownership over time, but Merck is the longstanding brand reference point for Sinemet. [2]
Generic supplier base (oral tablets/capsules)
The US generic supplier set is large and changes with approvals and discontinuations. The authoritative way to map “who supplies” is to enumerate currently listed FDA ANDA products by strength and dosage form. In this context, the only rigorous published supplier source is FDA’s Orange Book entry list for “carbidopa and levodopa” products and their ANDA holders.
How to identify the exact “supplier” list for procurement (FDA Orange Book method)
For business procurement, the supplier list is the ANDA holder (generic) or NDA holder (brand) tied to each dosage form, strength, and release type. The FDA Orange Book is the controlled reference for approved product holders and patent-linked entries.
What Orange Book provides for supplier mapping
- NDA/ANDA holder name (the legal manufacturer/marketing authorization holder)
- Dosage form (tablet/capsule/gel)
- Strengths
- Labeler changes that affect procurement eligibility
Carbidopa and levodopa are indexed in the FDA Orange Book under drug substance “levodopa, carbidopa” and are further separated by product specifics. [3]
Core supplier list by product line (actionable categories)
Because “supplier” depends on the dosage form, the supplier landscape is best treated as procurement categories:
1) Intestinal gel infusion (Duopa)
- AbbVie (NDA holder for Duopa intestinal gel) [1]
2) Oral immediate-release tablets and capsules (Sinemet and generics)
- Merck (brand anchor for Sinemet oral IR) [2]
- Generic ANDA holders (enumerate via Orange Book “carbidopa and levodopa” product listings by strength/dosage form) [3]
3) Oral ER/other release forms
- Orange Book enumeration required by strength and release type because availability and holders differ by formulation and bioavailability profile. [3]
Supplier-relevant manufacturing levers (what shifts availability)
Carbidopa and levodopa supply risk and lead times usually track with:
- Dosage-form complexity: intestinal gel has a tighter qualified ecosystem than IR tablets.
- Regulatory lock-in: a given holder’s approval ties them to specific label strengths, excipients, and manufacturing controls.
- Market access: generic oral products can cycle with approvals and discontinuations, making Orange Book holder lists the most reliable procurement starting point. [3]
Procurement shortlist strategy (lowest friction)
Use the following hierarchy to produce a procurement-ready supplier shortlist:
- Duopa gel: contract directly with the product’s NDA holder marketed in your region (US: AbbVie). [1]
- Oral IR: choose ANDA holders that are listed for the exact strength and dosage form in FDA Orange Book; avoid substituting across ER/IR or capsule/tablet without label alignment. [3]
- Plan for multiple SKUs: carbidopa/levodopa is sold across many strengths; supplier availability often differs by strength.
Where patent considerations intersect supply
Carbidopa/levodopa is a long-established regimen. Patent status mostly affects brand vs generic competition, not raw API supply. Supplier decisions should therefore focus on:
- which holders have current approvals for each dosage form and strength in Orange Book
- which holds have active commercial supply (market availability), which often diverges from approval lists
Key Takeaways
- Duopa intestinal gel is concentrated with AbbVie as the US NDA holder. [1]
- Oral carbidopa/levodopa is broad and genericized; the supplier roster is best derived from FDA Orange Book ANDA holder listings by strength and dosage form. [3]
- Procurement must be dosage-form specific because “carbidopa/levodopa” spans IR tablets/capsules and intestinal gel with materially different supplier ecosystems.
- Brand anchor for oral IR is Sinemet (carbidopa and levodopa) with Merck as a longstanding brand reference point. [2]
FAQs
1) Is Duopa the only intestinal carbidopa/levodopa product?
Duopa is the main carbidopa/levodopa intestinal gel product in the US marketed under that name, and it has AbbVie as the product’s listed NDA holder. [1]
2) How do I build an authoritative list of suppliers for oral carbidopa/levodopa?
Use the FDA Orange Book listings for “carbidopa and levodopa” and take the current ANDA holder tied to the exact strength and dosage form. [3]
3) Do oral and intestinal gel products share the same suppliers?
They do not reliably share procurement suppliers because intestinal gel requires a delivery ecosystem and different manufacturing controls than oral IR tablets/capsules. The Duopa holder is AbbVie. [1]
4) Can I substitute carbidopa/levodopa ER for IR without changing suppliers?
Not as a like-for-like product. ER vs IR strengths and approvals are listed separately in the Orange Book, and suppliers vary by formulation. [3]
5) Does patent status determine who supplies generic oral carbidopa/levodopa?
Patent status affects brand/generic competition, but the operational supplier set is defined by current approvals and commercial labeling, which are captured in the Orange Book holder list for each dosage form and strength. [3]
References
[1] AbbVie. (n.d.). DUOPA (carbidopa and levodopa intestinal gel) prescribing information and label. Retrieved from AbbVie product documentation.
[2] Merck. (n.d.). Sinemet (carbidopa and levodopa) prescribing information. Retrieved from Merck label documentation.
[3] U.S. Food and Drug Administration. (n.d.). Drugs@FDA and Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (carbidopa and levodopa). FDA.
