Services / US generics market entry

Enter the US generics market

Market data tells you what to make. We find the US company that will buy it, and stay on your side until the supply contract is signed.

  • First sheet free, in two working days
  • Paid mostly from the revenue you win
  • No fee for US buyers

One molecule’s US record, on one page

Sample sheet from public data, November 2026

Symbicort

Budesonide and formoterol, metered inhalation aerosol

Orange Book patents and exclusivities
None listed on 9 Oct 20261
Approved generic applications
21
Authorized generic, sold under the brand’s own approval
Listed by AstraZeneca and 2 other labelers2
First Paragraph IV patent challenge
June 20183
Medicare Part D spending, 2024
US$597.8 million4

An approved count is not a competitor count: generic applications under review are confidential. An NDC listing is the labeler’s own filing, not an approval. FDA’s Paragraph IV list gives a last qualifying patent expiring 16 Oct 20283, and a challenge is not a win or an approval. Spending is CMS’s row “Symbicort”, before rebates and Medicare only, linked to the drug by PhaseFolio through its FDA trade name.

  1. FDA Orange Book data files, built 9 Oct 2026
  2. FDA National Drug Code Directory, built 4 Nov 2026
  3. FDA Paragraph IV certifications list, 27 Oct 2026
  4. CMS Medicare Part D Spending by Drug, 2024 data

A report tells you what to make. We find who buys it.

Your portfolio team already knows the market. What it rarely has is a US buyer asking for your product, and someone on your side while the terms are agreed.

We start from the buyer

We ask US generic companies, distributors and hospital buyers which molecules they need a second source for, then bring those requests to manufacturers who can make them.

We earn when you do

Most of our fee is a share of the revenue you win. We only spend time on products a buyer will take, and we stay with you through documents, samples and follow-ups until the contract is signed.

The public US record, on one page

FDA approvals, patent challenges, authorized generics, shortages and Medicare spending sit with different agencies under different names. We link them to the same drug and cite every figure. Your first sheet is free.

Buying in the US? Get a second source.

Name the molecule. We bring you manufacturers whose FDA approvals and product listings are on a molecule sheet both sides read from. It costs you nothing: the manufacturer pays us, and we tell you so up front.

How it works

  1. 1

    Free molecule sheet

    Name one product. Its US record in two working days.

  2. 2

    Opportunity scan

    Your whole portfolio against the US market. A fixed fee, credited to your commission.

  3. 3

    Introductions

    Meetings with US buyers who need your product.

  4. 4

    Representation

    We stay on it until the supply contract is signed.

Get your free molecule sheet

Email us a product. We send its US record within two working days and show you where it fits.

What to send

  • Your company and the country you make in
  • The products or molecules you make, or want to make
  • Finished doses, active ingredients, or both
  • Or, for a US buyer: the molecule you need a second source for

We never share your product list with a competing manufacturer. Privacy policy

Molecule sheets draw on FDA’s Orange Book, Paragraph IV list, National Drug Code Directory and drug shortage data (through openFDA), NLM’s RxNorm, and CMS’s Medicare Part D and Part B spending by drug. Each figure names its source and date. A missing patent, challenge or shortage record never means there is none. Medicare spending is before rebates and covers Medicare only.

This product uses publicly available data courtesy of the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product. FDA and CMS do not endorse PhaseFolio. Not legal, medical or investment advice.