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

Informational only - not investment advice.

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

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 | MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | Prescription | not listed | Yes |
| 002 | MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | Prescription | not listed | Yes |
| 003 | MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | Prescription | not listed | Yes |
| 004 | MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | Prescription | not listed | Yes |
| 005 | MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | Prescription | not listed | Yes |
| 006 | MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | Prescription | not listed | Yes |
| 007 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | Prescription | not listed | Yes |
| 008 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | Prescription | not listed | Yes |
| 009 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | Prescription | not listed | Yes |
| 010 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | Prescription | not listed | Yes |
| 011 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | Prescription | not listed | Yes |
| 012 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | Prescription | not listed | Yes |
| 013 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/2.4ML (4.17MG/ML) | Prescription | not listed | Yes |
| 014 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 20MG/2.4ML (8.33MG/ML) | Prescription | not listed | Yes |
| 015 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 30MG/2.4ML (12.5MG/ML) | Prescription | not listed | Yes |
| 016 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 40MG/2.4ML (16.7MG/ML) | Prescription | not listed | Yes |
| 017 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 50MG/2.4ML (20.8MG/ML) | Prescription | not listed | Yes |
| 018 | MOUNJARO | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 60MG/2.4ML (25MG/ML) | Prescription | not listed | Yes |
| 019 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 10MG/2.4ML (4.17MG/ML) | Prescription | not listed | Yes |
| 020 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 20MG/2.4ML (8.33MG/ML) | Prescription | not listed | Yes |
| 021 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 30MG/2.4ML (12.5MG/ML) | Prescription | not listed | Yes |
| 022 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 40MG/2.4ML (16.7MG/ML) | Prescription | not listed | Yes |
| 023 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION | SUBCUTANEOUS | 50MG/2.4ML (20.8MG/ML) | Prescription | not listed | Yes |
| 024 | MOUNJARO 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.
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- Patent 12453756, product 001; listed patent expiry date: 2039-06-14.
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- Patent 12343382, product 007; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 007; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 007; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 008; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 008; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 008; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 008; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 008; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 008; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 009; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 009; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 009; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 009; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 009; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 009; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 010; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 010; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 010; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 010; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 010; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 010; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 011; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 011; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 011; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 011; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 011; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 011; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 012; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 012; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 012; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 012; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 012; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 012; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 013; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 013; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 013; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 013; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 013; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 013; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 014; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 014; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 014; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 014; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 014; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 014; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 015; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 015; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 015; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 015; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 015; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 015; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 016; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 016; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 016; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 016; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 016; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 016; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 017; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 017; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 017; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 017; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 017; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 017; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 018; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 018; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 018; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 018; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 018; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 018; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 019; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 019; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 019; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 019; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 019; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 019; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 020; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 020; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 020; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 020; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 020; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 020; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 021; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 021; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 021; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 021; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 021; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 021; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 022; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 022; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 022; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 022; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 022; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 022; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 023; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 023; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 023; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 023; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 023; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 023; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 024; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 024; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 024; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 024; listed patent expiry date: 2039-07-22.
- Patent 12343382, product 024; listed patent expiry date: 2039-07-22.
- Patent 12343382, 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.
- Patent 12295987, product 001; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 001; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 002; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 002; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 003; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 003; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 004; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 004; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 005; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 005; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 006; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 006; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 007; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 007; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 008; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 008; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 009; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 009; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 010; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 010; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 011; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 011; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 012; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 012; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 013; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 013; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 014; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 014; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 015; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 015; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 016; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 016; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 017; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 017; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 018; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 018; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 019; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 019; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 020; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 020; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 021; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 021; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 022; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 022; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 023; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 023; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 024; listed patent expiry date: 2041-12-30.
- Patent 12295987, product 024; listed patent expiry date: 2041-12-30.
- 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 NPP, product 001; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 002; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 003; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 004; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 007; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 008; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 009; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 010; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 013; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 014; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 015; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 016; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 017; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 018; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 019; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 020; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 021; listed exclusivity date: 2028-12-19.
- Exclusivity NPP, product 022; listed exclusivity date: 2028-12-19.

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:NDA215866. FDA data retrieved 2026-08-07.

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