HealthRX.com · Printable cost worksheet
Ozempic cost record and FDA generic-status check
Write down what you pay for Ozempic now and how it is covered, then check the same FDA records this page uses before you ask a pharmacist or plan whether anything has changed. Each record carries its own date, so note the date you looked.
What you use and pay today
Ozempic dose and devicepen strength, or single-dose syringe
Pharmacy and fill size
What you paid at the last fill
Coverageemployer plan, Marketplace, Medicare Part D, Medicaid, none
Prior authorization or step therapy needed?
Savings program in use, and when it ends
What FDA records showed in autumn 2026
- The Orange Book lists drug-substance patent 8129343 with an expiry date of 5 December 2031 for Ozempic products.[1]
- Exclusivity I-961, tied to the kidney indication, is listed to 28 January 2028 for the three pens, not the single-dose syringes.[1]
- FDA's Paragraph IV list dated 28 September 2026 shows the first generic challenge to the 2 mg/1.5 mL and 4 mg/3 mL pens was submitted on 6 December 2021, with 7 applications that day; the 8 mg/3 mL pen followed on 21 December 2022 and the 2 mg/3 mL pen on 11 April 2024.[2]
- On that list, the first-applicant approval and marketing columns are blank for every Ozempic entry; FDA says a blank generally means the event has not happened or FDA has not decided.[3]
- A patent lawsuit filed within 45 days of notice generally postpones FDA approval of a generic for 30 months.[3]
- The Orange Book lists a patent expiring 17 February 2041 for the single-dose syringes, the latest date on any Ozempic product page.[4]
Records to look at again (each is updated by FDA)
- Orange Book patent and exclusivity page for NDA 209637, one page per product number
- Orange Book search for the active ingredient semaglutide: does any application other than NDA 209637 appear?
- FDA Paragraph IV Certifications List: the date printed on page 1, and the semaglutide injection rows
- Drugs@FDA for NDA 209637: any new approvals or supplements
- Your plan's current formulary entry for Ozempic and other GLP-1 medicines
Each time you check
| Date you looked | Record | Date printed on the record | What changed |
|---|---|---|---|
For the pharmacist, prescriber or plan
- Is there an FDA-approved generic or authorized generic of Ozempic that this pharmacy can order?
- What tier is Ozempic on my plan, and is prior authorization or step therapy required for my diagnosis?
- Does the manufacturer's savings program apply to my type of coverage?
- If coverage is denied, which other GLP-1 medicines does my plan cover?
- If someone offers me compounded semaglutide, is it an FDA-approved product, and where is it made?
Sources for the facts on this sheet
- U.S. Food and Drug Administration, Orange Book. Orange Book: Patent and Exclusivity for N209637, Product 002, Ozempic 4 mg/3 mL pen (1 mg doses). Accessed 2026-10-19. https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=002&Appl_No=209637&Appl_type=N
- U.S. Food and Drug Administration, Office of Generic Drugs. Paragraph IV Certifications List, September 28, 2026. Accessed 2026-10-19. https://www.fda.gov/media/166048/download
- U.S. Food and Drug Administration. Patent Certifications and Suitability Petitions. Accessed 2026-10-19. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions
- U.S. Food and Drug Administration, Orange Book. Orange Book: Patent and Exclusivity for N209637, Product 005, Ozempic 0.25 mg/0.5 mL single-dose syringe. Accessed 2026-10-19. https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=005&Appl_No=209637&Appl_type=N
This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.