Generic tirzepatide filing expected; patent protection into at least 2036

Research evidence excerpt

Generic tirzepatide filing expected; patent protection into at least 2036

Update

June 29, 2026 11:52 AM GMT

Morgan Stanley & Co. LLCMEli Lilly & Co. | North America Terence C Flynn, Ph.D.

Equity Analyst

Generic tirzepatide filing Terence.Flynn@morganstanley.comChris Yu, J.D., Ph.D. +1 212 761-2230

Chris.L.Yu@morganstanley.com +1 212 761-2535

expected; patent protection into Alexander Yevdokimov, Ph.D.

Research Associate

Alexander.Yevdokimov@morganstanley.com +1 212 761-2167

at least 2036 Hailey Horowitz

Hailey.Horowitz@morganstanley.com +1 212 761-5264

Sandoz (covered by Thibault Boutherin) announced that the FDA accepted its

Connor M Massari

applications for generic tirzepatide autoinjector applications referencing LLY's Equity Analyst

Mounjaro and Zepbound (LINK). We note this is not a surprise as tirzepatide is Connor.Massari@morganstanley.com +1 212 761-2417

Damien H Kerner

classified as a small molecule by the FDA, thus it is subject to the litigation timeline Research Associate

associated with Abbreviated New Drug Applications (ANDAs). See Exhibit 1 below. Damien.H.Kerner@morganstanley.com +1 212 761-3829

Specifically, the new chemical exclusivity (NCE) for tirzepatide expires on 5/13/2027, Morgan Stanley India Company Private Limited+

Saket Agarwalthereby allowing generics such as Sandoz to file its ANDA on or after 4/13/2026. We

expect LLY to file an ANDA lawsuit shortly at a District Court, which will start a 30- Saket.Agarwal@morganstanley.com +91 22 6995-4012

month stay preventing the FDA from approving Sandoz's applications for 30

Eli Lilly & Co. (LLY.N, LLY UN)

months.

Major Pharmaceuticals | United States of America

Mounjaro/Zepbound (tirzepatide) composition-of-matter (COM) patent is Stock Rating Overweight

US9,474,780, expiring on 1/5/2036 (LINK).