# ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN — FDA application NDA217806 Informational only - not investment advice. Application NDA217806 · type NDA · FDA status: approved · original approval 2023-11-08 Listed sponsor: ELI LILLY AND CO · [LLY company profile](/company/LLY/) · exact_unique Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers. ## FDA application facts | Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 001 | ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | Prescription | not listed | Yes | | 002 | ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | Prescription | not listed | Yes | | 003 | ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | Prescription | not listed | Yes | | 004 | ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | Prescription | not listed | Yes | | 005 | ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | Prescription | not listed | Yes | | 006 | ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | Prescription | not listed | Yes | | 007 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | Prescription | not listed | Yes | | 008 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | Prescription | not listed | Yes | | 009 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | Prescription | not listed | Yes | | 010 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | Prescription | not listed | Yes | | 011 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | Prescription | not listed | Yes | | 012 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | Prescription | not listed | Yes | | 013 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/2.4ML (4.17MG/ML) | Prescription | not listed | Yes | | 014 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 20MG/2.4ML (8.33MG/ML) | Prescription | not listed | Yes | | 015 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 30MG/2.4ML (12.5MG/ML) | Prescription | not listed | Yes | | 016 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 40MG/2.4ML (16.7MG/ML) | Prescription | not listed | Yes | | 017 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 50MG/2.4ML (20.8MG/ML) | Prescription | not listed | Yes | | 018 | ZEPBOUND | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 60MG/2.4ML (25MG/ML) | Prescription | not listed | Yes | | 019 | ZEPBOUND KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/2.4ML (4.17MG/ML) | Prescription | not listed | Yes | | 020 | ZEPBOUND KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 20MG/2.4ML (8.33MG/ML) | Prescription | not listed | Yes | | 021 | ZEPBOUND KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 30MG/2.4ML (12.5MG/ML) | Prescription | not listed | Yes | | 022 | ZEPBOUND KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 40MG/2.4ML (16.7MG/ML) | Prescription | not listed | Yes | | 023 | ZEPBOUND KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 50MG/2.4ML (20.8MG/ML) | Prescription | not listed | Yes | | 024 | ZEPBOUND KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 60MG/2.4ML (25MG/ML) | Prescription | not listed | Yes | ## Orange Book patent and exclusivity listings - Patent 9474780, product 001; listed patent expiry date: 2036-01-05. - Patent 9474780, product 002; listed patent expiry date: 2036-01-05. - Patent 9474780, product 003; listed patent expiry date: 2036-01-05. - Patent 9474780, product 004; listed patent expiry date: 2036-01-05. - Patent 9474780, product 005; listed patent expiry date: 2036-01-05. - Patent 9474780, product 006; listed patent expiry date: 2036-01-05. - Patent 9474780, product 007; listed patent expiry date: 2036-01-05. - Patent 9474780, product 008; listed patent expiry date: 2036-01-05. - Patent 9474780, product 009; listed patent expiry date: 2036-01-05. - Patent 9474780, product 010; listed patent expiry date: 2036-01-05. - Patent 9474780, product 011; listed patent expiry date: 2036-01-05. - Patent 9474780, product 012; listed patent expiry date: 2036-01-05. - Patent 9474780, product 013; listed patent expiry date: 2036-01-05. - Patent 9474780, product 014; listed patent expiry date: 2036-01-05. - Patent 9474780, product 015; listed patent expiry date: 2036-01-05. - Patent 9474780, product 016; listed patent expiry date: 2036-01-05. - Patent 9474780, product 017; listed patent expiry date: 2036-01-05. - Patent 9474780, product 018; listed patent expiry date: 2036-01-05. - Patent 9474780, product 019; listed patent expiry date: 2036-01-05. - Patent 9474780, product 020; listed patent expiry date: 2036-01-05. - Patent 9474780, product 021; listed patent expiry date: 2036-01-05. - Patent 9474780, product 022; listed patent expiry date: 2036-01-05. - Patent 9474780, product 023; listed patent expiry date: 2036-01-05. - Patent 9474780, product 024; listed patent expiry date: 2036-01-05. - Patent 11357820, product 001; listed patent expiry date: 2039-06-14. - Patent 11357820, product 002; listed patent expiry date: 2039-06-14. - Patent 11357820, product 003; listed patent expiry date: 2039-06-14. - Patent 11357820, product 004; listed patent expiry date: 2039-06-14. - Patent 11357820, product 005; listed patent expiry date: 2039-06-14. - Patent 11357820, product 006; listed patent expiry date: 2039-06-14. - Patent 11357820, product 007; 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listed patent expiry date: 2039-07-22. - Patent 12453758, product 001; listed patent expiry date: 2039-07-22. - Patent 12453758, product 001; listed patent expiry date: 2039-07-22. - Patent 12453758, product 001; listed patent expiry date: 2039-07-22. - Patent 12453758, product 002; listed patent expiry date: 2039-07-22. - Patent 12453758, product 002; listed patent expiry date: 2039-07-22. - Patent 12453758, product 002; listed patent expiry date: 2039-07-22. - Patent 12453758, product 002; listed patent expiry date: 2039-07-22. - Patent 12453758, product 003; listed patent expiry date: 2039-07-22. - Patent 12453758, product 003; listed patent expiry date: 2039-07-22. - Patent 12453758, product 003; listed patent expiry date: 2039-07-22. - Patent 12453758, product 003; listed patent expiry date: 2039-07-22. - Patent 12453758, product 004; listed patent expiry date: 2039-07-22. - Patent 12453758, product 004; listed patent expiry date: 2039-07-22. - Patent 12453758, product 004; listed patent expiry date: 2039-07-22. - Patent 12453758, product 004; 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listed patent expiry date: 2039-07-22. - Patent 12453758, product 016; listed patent expiry date: 2039-07-22. - Patent 12453758, product 016; listed patent expiry date: 2039-07-22. - Patent 12453758, product 016; listed patent expiry date: 2039-07-22. - Patent 12453758, product 017; listed patent expiry date: 2039-07-22. - Patent 12453758, product 017; listed patent expiry date: 2039-07-22. - Patent 12453758, product 017; listed patent expiry date: 2039-07-22. - Patent 12453758, product 017; listed patent expiry date: 2039-07-22. - Patent 12453758, product 018; listed patent expiry date: 2039-07-22. - Patent 12453758, product 018; listed patent expiry date: 2039-07-22. - Patent 12453758, product 018; listed patent expiry date: 2039-07-22. - Patent 12453758, product 018; listed patent expiry date: 2039-07-22. - Patent 12453758, product 019; listed patent expiry date: 2039-07-22. - Patent 12453758, product 019; listed patent expiry date: 2039-07-22. - Patent 12453758, product 019; listed patent expiry date: 2039-07-22. - Patent 12453758, product 019; listed patent expiry date: 2039-07-22. - Patent 12453758, product 020; listed patent expiry date: 2039-07-22. - Patent 12453758, product 020; listed patent expiry date: 2039-07-22. - Patent 12453758, product 020; listed patent expiry date: 2039-07-22. - Patent 12453758, product 020; listed patent expiry date: 2039-07-22. - Patent 12453758, product 021; listed patent expiry date: 2039-07-22. - Patent 12453758, product 021; listed patent expiry date: 2039-07-22. - Patent 12453758, product 021; listed patent expiry date: 2039-07-22. - Patent 12453758, product 021; listed patent expiry date: 2039-07-22. - Patent 12453758, product 022; listed patent expiry date: 2039-07-22. - Patent 12453758, product 022; listed patent expiry date: 2039-07-22. - Patent 12453758, product 022; listed patent expiry date: 2039-07-22. - Patent 12453758, product 022; listed patent expiry date: 2039-07-22. - Patent 12453758, product 023; listed patent expiry date: 2039-07-22. - Patent 12453758, product 023; listed patent expiry date: 2039-07-22. - Patent 12453758, product 023; listed patent expiry date: 2039-07-22. - Patent 12453758, product 023; listed patent expiry date: 2039-07-22. - Patent 12453758, product 024; listed patent expiry date: 2039-07-22. - Patent 12453758, product 024; listed patent expiry date: 2039-07-22. - Patent 12453758, product 024; listed patent expiry date: 2039-07-22. - Patent 12453758, product 024; listed patent expiry date: 2039-07-22. - Patent 12616740, product 001; listed patent expiry date: 2039-07-22. - Patent 12616740, product 001; listed patent expiry date: 2039-07-22. - Patent 12616740, product 001; listed patent expiry date: 2039-07-22. - Patent 12616740, product 002; listed patent expiry date: 2039-07-22. - Patent 12616740, product 002; listed patent expiry date: 2039-07-22. - Patent 12616740, product 002; listed patent expiry date: 2039-07-22. - Patent 12616740, product 003; listed patent expiry date: 2039-07-22. - Patent 12616740, product 003; listed patent expiry date: 2039-07-22. - Patent 12616740, product 003; listed patent expiry date: 2039-07-22. - Patent 12616740, product 004; listed patent expiry date: 2039-07-22. - Patent 12616740, product 004; listed patent expiry date: 2039-07-22. - Patent 12616740, product 004; listed patent expiry date: 2039-07-22. - Patent 12616740, product 005; listed patent expiry date: 2039-07-22. - Patent 12616740, product 005; listed patent expiry date: 2039-07-22. - Patent 12616740, product 005; listed patent expiry date: 2039-07-22. - Patent 12616740, product 006; listed patent expiry date: 2039-07-22. - Patent 12616740, product 006; listed patent expiry date: 2039-07-22. - Patent 12616740, product 006; listed patent expiry date: 2039-07-22. - Patent 12616740, product 007; listed patent expiry date: 2039-07-22. - Patent 12616740, product 007; listed patent expiry date: 2039-07-22. - Patent 12616740, product 007; listed patent expiry date: 2039-07-22. - Patent 12616740, product 008; listed patent expiry date: 2039-07-22. - Patent 12616740, product 008; listed patent expiry date: 2039-07-22. - Patent 12616740, product 008; listed patent expiry date: 2039-07-22. - Patent 12616740, product 009; listed patent expiry date: 2039-07-22. - Patent 12616740, product 009; listed patent expiry date: 2039-07-22. - Patent 12616740, product 009; listed patent expiry date: 2039-07-22. - Patent 12616740, product 010; listed patent expiry date: 2039-07-22. - Patent 12616740, product 010; listed patent expiry date: 2039-07-22. - Patent 12616740, product 010; listed patent expiry date: 2039-07-22. - Patent 12616740, product 011; listed patent expiry date: 2039-07-22. - Patent 12616740, product 011; listed patent expiry date: 2039-07-22. - Patent 12616740, product 011; listed patent expiry date: 2039-07-22. - Patent 12616740, product 012; listed patent expiry date: 2039-07-22. - Patent 12616740, product 012; listed patent expiry date: 2039-07-22. - Patent 12616740, product 012; listed patent expiry date: 2039-07-22. - Patent 12616740, product 013; listed patent expiry date: 2039-07-22. - Patent 12616740, product 013; listed patent expiry date: 2039-07-22. - Patent 12616740, product 013; listed patent expiry date: 2039-07-22. - Patent 12616740, product 014; listed patent expiry date: 2039-07-22. - Patent 12616740, product 014; listed patent expiry date: 2039-07-22. - Patent 12616740, product 014; listed patent expiry date: 2039-07-22. - Patent 12616740, product 015; listed patent expiry date: 2039-07-22. - Patent 12616740, product 015; listed patent expiry date: 2039-07-22. - Patent 12616740, product 015; listed patent expiry date: 2039-07-22. - Patent 12616740, product 016; listed patent expiry date: 2039-07-22. - Patent 12616740, product 016; listed patent expiry date: 2039-07-22. - Patent 12616740, product 016; listed patent expiry date: 2039-07-22. - Patent 12616740, product 017; listed patent expiry date: 2039-07-22. - Patent 12616740, product 017; listed patent expiry date: 2039-07-22. - Patent 12616740, product 017; listed patent expiry date: 2039-07-22. - Patent 12616740, product 018; listed patent expiry date: 2039-07-22. - Patent 12616740, product 018; listed patent expiry date: 2039-07-22. - Patent 12616740, product 018; listed patent expiry date: 2039-07-22. - Patent 12616740, product 019; listed patent expiry date: 2039-07-22. - Patent 12616740, product 019; listed patent expiry date: 2039-07-22. - Patent 12616740, product 019; listed patent expiry date: 2039-07-22. - Patent 12616740, product 020; listed patent expiry date: 2039-07-22. - Patent 12616740, product 020; listed patent expiry date: 2039-07-22. - Patent 12616740, product 020; listed patent expiry date: 2039-07-22. - Patent 12616740, product 021; listed patent expiry date: 2039-07-22. - Patent 12616740, product 021; listed patent expiry date: 2039-07-22. - Patent 12616740, product 021; listed patent expiry date: 2039-07-22. - Patent 12616740, product 022; listed patent expiry date: 2039-07-22. - Patent 12616740, product 022; listed patent expiry date: 2039-07-22. - Patent 12616740, product 022; listed patent expiry date: 2039-07-22. - Patent 12616740, product 023; listed patent expiry date: 2039-07-22. - Patent 12616740, product 023; listed patent expiry date: 2039-07-22. - Patent 12616740, product 023; listed patent expiry date: 2039-07-22. - Patent 12616740, product 024; listed patent expiry date: 2039-07-22. - Patent 12616740, product 024; listed patent expiry date: 2039-07-22. - Patent 12616740, product 024; listed patent expiry date: 2039-07-22. - Exclusivity NP, product 001; listed exclusivity date: 2026-11-08. - Exclusivity NP, product 002; listed exclusivity date: 2026-11-08. - Exclusivity NP, product 003; listed exclusivity date: 2026-11-08. - Exclusivity NP, product 004; listed exclusivity date: 2026-11-08. - Exclusivity NP, product 005; listed exclusivity date: 2026-11-08. - Exclusivity NP, product 006; listed exclusivity date: 2026-11-08. - Exclusivity NCE, product 001; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 002; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 003; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 004; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 005; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 006; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 007; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 008; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 009; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 010; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 011; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 012; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 013; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 014; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 015; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 016; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 017; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 018; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 019; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 020; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 021; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 022; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 023; listed exclusivity date: 2027-05-13. - Exclusivity NCE, product 024; listed exclusivity date: 2027-05-13. - Exclusivity M-82, product 001; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 002; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 003; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 004; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 005; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 006; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 007; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 008; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 009; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 010; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 011; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 012; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 013; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 014; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 015; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 016; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 017; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 018; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 019; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 020; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 021; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 022; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 023; listed exclusivity date: 2027-10-18. - Exclusivity M-82, product 024; listed exclusivity date: 2027-10-18. - Exclusivity I-958, product 001; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 002; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 003; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 004; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 005; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 006; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 007; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 008; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 009; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 010; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 011; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 012; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 013; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 014; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 015; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 016; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 017; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 018; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 019; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 020; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 021; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 022; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 023; listed exclusivity date: 2027-12-20. - Exclusivity I-958, product 024; listed exclusivity date: 2027-12-20. Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied. ## Compound cross-links - TIRZEPATIDE · UNII OYN3CCI6QE · no lmmol compound match Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link. ## Related pages - [Sponsor company](/company/LLY/) - [FDA-approved application index](/drug/) - [Large-cap biopharma](/compare/pharma/) Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA217806. FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.