Tentative approval, when FDA clears a generic that cannot yet be sold

On Jan. 2, 2024, FDA's Office of Generic Drugs tentatively approved an application for generic sitagliptin, a diabetes tablet, according to the agency's Drugs@FDA data files¹⁰. The agency had finished its review. The company still could not sell the product. In the Drugs@FDA files dated Oct. 30, 2026, nearly three years later, the application still carried a tentative-approval status, even though the first final approvals for other generic sitagliptin tablet applications had come through in late December 2025 and January 2026.

That status is called tentative approval, and FDA issues a lot of them. In fiscal 2025 the agency tentatively approved 250 generic applications and gave final approval to 689, according to its monthly program activity report² for that year, figures that match its performance report to Congress. By the end of September 2025, 566 generic applications were sitting in tentative-approval status, up from 469 three years earlier.

A tentative approval is a waiting room. FDA has decided the product is good enough to approve, but a patent, an exclusivity period or a lawsuit keeps it off US shelves. The same mechanism does a second job abroad, letting FDA clear HIV medicines that cannot yet be sold in the United States so that the US global AIDS program can buy them for other countries.

What tentative approval means in law

Congress wrote a definition into the drug law in the Medicare Modernization Act of 2003⁵. A tentative approval is "notification to an applicant by the Secretary that an application under this subsection meets the requirements" for approval "but cannot receive effective approval" because of patent protections or an exclusivity period. The next sentence closes the door: "A drug that is granted tentative approval by the Secretary is not an approved drug and shall not have an effective approval until the Secretary issues an approval after any necessary additional review of the application."

FDA's regulation, 21 CFR 314.105(d)⁶, lists the blocks that lead to a tentative approval letter instead of a final one. They include the patent-related waiting periods in FDA's rules, the 5-year (new chemical entity) and 3-year exclusivities for new drugs, 7-year orphan drug exclusivity, pediatric exclusivity, and the exclusivity Congress created for certain new anti-infective drugs. The rule adds that a tentative approval rests on the information FDA has when it issues the letter, so it can change.

The practical effect is that the product cannot be marketed. FDA "will not include drug products with tentative approvals in the Orange Book because a drug product that is granted tentative approval is not an approved drug product," the Orange Book preface¹² says. That is why tentatively approved products do not show up in FDA's Orange Book or on GxRadar's approval counts, which track final approvals.

Why products sit in tentative status

Most tentative approvals trace to the patent and exclusivity rules of the Hatch-Waxman Act. A generic applicant that certifies it will wait for a patent to expire, a Paragraph III certification, can be tentatively approved years before the expiration date. One that challenges a patent with a Paragraph IV certification and gets sued faces a 30-month stay, during which FDA can keep reviewing and can tentatively approve. Later filers can be held behind a first filer's 180-day exclusivity.

Settlements extend the wait in another way. Many patent cases end with an agreed entry date, and a generic that has already been tentatively approved simply holds its status until that date arrives. Our piece on pay-for-delay settlements covers what the FTC learns from those agreements, and our guide to patent thickets explains why some brand drugs carry dozens of listed patents for generics to work through.

Tentative approval also protects a first filer's reward. Under the 2003 law, a first applicant forfeits its 180-day exclusivity if it "fails to obtain tentative approval of the application within 30 months after the date on which the application is filed," unless the delay comes from a change in approval requirements imposed after filing. For a first filer, a tentative approval letter can be worth a great deal.

Leaving the waiting room is not automatic. Under FDA's regulation⁶, a tentative approval rests on the information the agency has when it issues the letter, and the product is not approved "until FDA issues an approval after any necessary additional review." The sitagliptin application in the first paragraph shows how long that can take.

How many generics are waiting

FDA publishes generic approval actions monthly. The table combines the agency's fiscal-year totals with its count of applications in tentative-approval status, which FDA describes as products "ready for approval" that cannot be approved "due to a patent or exclusivity related to the reference listed drug product."

Figures come from FDA's activity reports for fiscal 2022⁴, fiscal 2023³, fiscal 2024¹ and fiscal 2025; the October 2022 status count is the first month of the 2023 report. The share column is GxRadar's arithmetic, tentative approvals divided by the sum of final and tentative approvals.

Two trends stand out. Final approvals have drifted down from 782 in fiscal 2023 to 689 in fiscal 2025, while tentative approvals jumped to 250 in fiscal 2025, the highest of the four years. The pile of applications in tentative status grew by 97 over three years. Those are applications that have cleared FDA's scientific review and are waiting on legal events, so the backlog says more about patents and exclusivity on brand drugs than about FDA's review speed.

Tentative approvals and global HIV treatment

The President's Emergency Plan for AIDS Relief, or PEPFAR, is the US government's global HIV program, led by a State Department bureau. FDA's PEPFAR page⁷ says the program "only procures ARVs that have been granted tentative approval or approval by CDER to be distributed outside the United States." Antiretrovirals that would otherwise qualify for final approval but are blocked by US patents or exclusivity receive tentative approval, and FDA's PEPFAR database FAQ⁸ explains that such drugs "are not eligible for marketing in the U.S. but can be distributed outside the U.S.," with PEPFAR money able to buy them, "usually at a cost savings to the program."

FDA has also encouraged manufacturers since 2004 to submit fixed-dose combinations and co-packaged versions of previously approved HIV drugs, and it gives these applications expedited review. In an August 2022 presentation⁹, an Office of Generic Drugs official reported 239 PEPFAR applications covering 303 products to date. GxRadar's count of the Oct. 30, 2026, Drugs@FDA files¹⁰ found 158 applications with products in tentative-approval status that contain antiretroviral ingredients, split evenly between 79 generic applications and 79 new drug applications; 65 of those NDAs combine two or more ingredients. Many such NDAs use the 505(b)(2) pathway; CDER's 2023 approvals report¹¹, for example, lists a dolutegravir, emtricitabine and tenofovir alafenamide combination as both a PEPFAR application and a 505(b)(2) approval.

CDER's year-end approval reports flag these products separately. FDA's GDUFA report for fiscal 2026, which ended Sept. 30, is the next place the tentative approval count will appear, along with the September 2026 total of applications still waiting.