FDA Orange Book · active-ingredient family
Amoxicillin; clarithromycin; vonoprazan fumarate
Amoxicillin; clarithromycin; vonoprazan fumarate: 1 brand, 0 generics; first approved May 03, 2022; on patent until Apr 10, 2030.
On patent2 exclusivity periods
Generic status & protection
Protected until Apr 10, 2030 (earliest listed patent expiry).
Earliest patent expiry Apr 10, 2030Latest exclusivity ends May 03, 2032
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Apr 10, 2030
in 3 yr 9 mo
Originator applications
Brand (NDA) products
PHATHOMNDA 2151522022
PHATHOMNDA 2151522022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET | ORAL | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
May 03, 2027
in 10 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
May 03, 2032
in 5 yr 11 mo
Orange Book patent file
Listed patents
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7977488 | Apr 10, 2030 | in 3 yr 9 mo | Substance |
| 9186411 | Aug 11, 2030 | in 4 yr 2 mo | Product |
FDA approval span
Approval history
First approval
May 03, 2022
4 yr 3 mo ago
Most recent approval
May 03, 2022
4 yr 3 mo ago
All 1 application were approved in 2022.
Brand (NDA) 1100%
Generic (ANDA) 00%
Amoxicillin; clarithromycin; vonoprazan fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
