grepcent public filings, reorganized for comparison

ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN — FDA application NDA217806

Application NDA217806 · type NDA · FDA status: approved · original approval 2023-11-08

Listed sponsor: ELI LILLY AND CO · LLY company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescriptionnot listedYes
002ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescriptionnot listedYes
003ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescriptionnot listedYes
004ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescriptionnot listedYes
005ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescriptionnot listedYes
006ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescriptionnot listedYes
007ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescriptionnot listedYes
008ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescriptionnot listedYes
009ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescriptionnot listedYes
010ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescriptionnot listedYes
011ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescriptionnot listedYes
012ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescriptionnot listedYes
013ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/2.4ML (4.17MG/ML)Prescriptionnot listedYes
014ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS20MG/2.4ML (8.33MG/ML)Prescriptionnot listedYes
015ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS30MG/2.4ML (12.5MG/ML)Prescriptionnot listedYes
016ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS40MG/2.4ML (16.7MG/ML)Prescriptionnot listedYes
017ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS50MG/2.4ML (20.8MG/ML)Prescriptionnot listedYes
018ZEPBOUNDTIRZEPATIDESOLUTIONSUBCUTANEOUS60MG/2.4ML (25MG/ML)Prescriptionnot listedYes
019ZEPBOUND KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/2.4ML (4.17MG/ML)Prescriptionnot listedYes
020ZEPBOUND KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS20MG/2.4ML (8.33MG/ML)Prescriptionnot listedYes
021ZEPBOUND KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS30MG/2.4ML (12.5MG/ML)Prescriptionnot listedYes
022ZEPBOUND KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS40MG/2.4ML (16.7MG/ML)Prescriptionnot listedYes
023ZEPBOUND KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS50MG/2.4ML (20.8MG/ML)Prescriptionnot listedYes
024ZEPBOUND KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS60MG/2.4ML (25MG/ML)Prescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 9474780001listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780002listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780003listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780004listed patent expiry date: 2036-01-05drug substance, drug product
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Patent 9474780006listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780007listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780008listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780009listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780010listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780011listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780012listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780013listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780014listed patent expiry date: 2036-01-05drug substance, drug product
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Patent 9474780019listed patent expiry date: 2036-01-05drug substance, drug product
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Patent 9474780023listed patent expiry date: 2036-01-05drug substance, drug product
Patent 9474780024listed patent expiry date: 2036-01-05drug substance, drug product
Patent 11357820001listed patent expiry date: 2039-06-14drug product
Patent 11357820002listed patent expiry date: 2039-06-14drug product
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Patent 12629404001listed patent expiry date: 2039-06-14drug product, U-4531
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Exclusivity NP001listed exclusivity date: 2026-11-08FDA code as listed
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NDA217806 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217806 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217806 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002023-11-081.002026-11-081.002027-05-131.002027-10-181.002027-12-201.002036-01-051.002039-06-141.002039-07-221.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

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Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.