Is there a generic for Tirzepatide?

The FDA Orange Book does not currently list an approved generic (ANDA) for Tirzepatide. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Tirzepatide?

ZEPBOUND (NDA 217806, ELI LILLY AND CO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Tirzepatide?

The Orange Book lists 10 patents against Tirzepatide products, with the earliest listed expiry in 2036. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Tirzepatide have FDA marketing exclusivity?

Yes. The Orange Book records 120 marketing-exclusivity periods for Tirzepatide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Tirzepatide are approved?

Tirzepatide is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Tirzepatide

Tirzepatide is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ZEPBOUND · NDA 217806

Brand (NDA)

Generics (ANDA)

Listed patents

120

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
ZEPBOUNDRLD×24	ELI LILLY AND CO	NDA 217806	—	Mar 28, 2024
MOUNJARORLD×24	ELI LILLY AND CO	NDA 215866	—	Jul 28, 2023

Marketing exclusivity (120)

NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPNew product exclusivity (3 years)
Nov 08, 2026
in 5 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPNew product exclusivity (3 years)
Nov 08, 2026
in 5 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPNew product exclusivity (3 years)
Nov 08, 2026
in 5 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPNew product exclusivity (3 years)
Nov 08, 2026
in 5 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPNew product exclusivity (3 years)
Nov 08, 2026
in 5 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
NPNew product exclusivity (3 years)
Nov 08, 2026
in 5 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9474780	Jan 05, 2036	in 9 yr 8 mo	SubstanceProductU-4374
12453755	Jun 14, 2039	in 13 yr 2 mo	U-4386
12629404	Jun 14, 2039	in 13 yr 2 mo	ProductU-4533
11357820	Jun 14, 2039	in 13 yr 2 mo	SubstanceProduct
12453756	Jun 14, 2039	in 13 yr 2 mo	Product
11918623	Jun 14, 2039	in 13 yr 2 mo	U-3855
12343382	Jul 22, 2039	in 13 yr 3 mo	U-4229
12616740	Jul 22, 2039	in 13 yr 3 mo	U-4500
12453758	Jul 22, 2039	in 13 yr 3 mo	U-4311
12295987	Dec 30, 2041	in 15 yr 9 mo	U-4193

Tirzepatide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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