grepcent public filings, reorganized for comparison

MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN — FDA application NDA215866

Application NDA215866 · type NDA · FDA status: approved · original approval 2022-05-13

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
001MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescriptionnot listedYes
002MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescriptionnot listedYes
003MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescriptionnot listedYes
004MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescriptionnot listedYes
005MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescriptionnot listedYes
006MOUNJARO (AUTOINJECTOR)TIRZEPATIDESOLUTIONSUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescriptionnot listedYes
007MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)Prescriptionnot listedYes
008MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)Prescriptionnot listedYes
009MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)Prescriptionnot listedYes
010MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)Prescriptionnot listedYes
011MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)Prescriptionnot listedYes
012MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)Prescriptionnot listedYes
013MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/2.4ML (4.17MG/ML)Prescriptionnot listedYes
014MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS20MG/2.4ML (8.33MG/ML)Prescriptionnot listedYes
015MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS30MG/2.4ML (12.5MG/ML)Prescriptionnot listedYes
016MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS40MG/2.4ML (16.7MG/ML)Prescriptionnot listedYes
017MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS50MG/2.4ML (20.8MG/ML)Prescriptionnot listedYes
018MOUNJAROTIRZEPATIDESOLUTIONSUBCUTANEOUS60MG/2.4ML (25MG/ML)Prescriptionnot listedYes
019MOUNJARO KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS10MG/2.4ML (4.17MG/ML)Prescriptionnot listedYes
020MOUNJARO KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS20MG/2.4ML (8.33MG/ML)Prescriptionnot listedYes
021MOUNJARO KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS30MG/2.4ML (12.5MG/ML)Prescriptionnot listedYes
022MOUNJARO KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS40MG/2.4ML (16.7MG/ML)Prescriptionnot listedYes
023MOUNJARO KWIKPENTIRZEPATIDESOLUTIONSUBCUTANEOUS50MG/2.4ML (20.8MG/ML)Prescriptionnot listedYes
024MOUNJARO 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, U-4374
Patent 9474780002listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780003listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780004listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780005listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780006listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780007listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780008listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780009listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780010listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780011listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780012listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780013listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780014listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780015listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780016listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780017listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780018listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780019listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780020listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780021listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780022listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780023listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 9474780024listed patent expiry date: 2036-01-05drug substance, drug product, U-4374
Patent 11357820001listed patent expiry date: 2039-06-14drug product
Patent 11357820002listed patent expiry date: 2039-06-14drug product
Patent 11357820003listed patent expiry date: 2039-06-14drug product
Patent 11357820004listed patent expiry date: 2039-06-14drug product
Patent 11357820005listed patent expiry date: 2039-06-14drug product
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Patent 11357820007listed patent expiry date: 2039-06-14drug substance, drug product
Patent 11357820008listed patent expiry date: 2039-06-14drug substance, drug product
Patent 11357820009listed patent expiry date: 2039-06-14drug substance, drug product
Patent 11357820010listed patent expiry date: 2039-06-14drug substance, drug product
Patent 11357820011listed patent expiry date: 2039-06-14drug substance, drug product
Patent 11357820012listed patent expiry date: 2039-06-14drug substance, drug product
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Patent 12453756001listed patent expiry date: 2039-06-14drug product
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Patent 12629404001listed patent expiry date: 2039-06-14drug product, U-4533
Patent 12629404001listed patent expiry date: 2039-06-14drug product, U-4534
Patent 12629404002listed patent expiry date: 2039-06-14drug product, U-4533
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NDA215866 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215866 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215866 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 marker0.001.002.002022-05-131.002027-05-131.002028-12-191.002036-01-051.002039-06-141.002039-07-221.002041-12-301.00

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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.