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COVID-19 Response and Update

Innovating access for tomorrow

We’ve developed hundreds of medicines across all dosage forms. Along the way, we’ve earned our reputation as a trusted leader in highly complex medicines. Our pipeline centers on meeting unmet needs, filling drug shortages and opening access to the world’s most advanced and critical medicines.

As of October 2025, we have 69 ANDAs pending (64% are complex products) and 44 additional products in development (95% are complex products).

Data as of October 2025. All trademarks listed below are the property of their respective owners.

Launch Date / Anticipated Launch Date

Launch Date / Anticipated Launch Date

Q1 2025

Mesalamine DR

Therapeutic Area - Gastroenterology

Referenced Brand - Asacol® HD

Dosage Form - Tablet

Approval - Q1’25

Launch - Q1’25

Everolimus

Therapeutic Area - Oncology

Referenced Brand - Afinitor®

Dosage Form - Tablet

Approval - Q1’25

Launch - Q1’25

Launch Date / Anticipated Launch Date

Q4 2025

Epinephrine

Therapeutic Area - Emergency/Critical Care
Referenced Brand - Adrenalin®

Dosage Form - SDV/MDV/PFS

Approval - Q4’25/Q1’26*

Launch - Q4’25/Q1’26

Prednisolone acetate

Therapeutic Area - Opthalmology

Referenced Brand - Pred-Forte®

Dosage Form - Ophthalmic

Approval - Q2’25

Launch - Q4’25

Risperidone ER

Therapeutic Area - Psychiatry
Referenced Brand - Risperdal Consta®

Dosage Form - Vial

Approval - Q3’25

Launch - Q4’25

Launch Date / Anticipated Launch Date

Q1 2026

Iohexol

Therapeutic Area - Diagnostic
Referenced Brand - Omnipaque®

Dosage Form - Vial

Approval - Q4’25*

Launch - Q1’26

Eltrombopag

Therapeutic Area - Hematology

Referenced Brand - Promacta®

Dosage Form - Tablet

Approval - Q1’26*

Launch - Q1’26

Epinephrine

Therapeutic Area - Emergency/Critical Care
Referenced Brand - Adrenalin®

Dosage Form - SDV/MDV/PFS

Approval - Q4’25/Q1’26*

Launch - Q4’25/Q1’26

Lanreotide injection

Therapeutic Area - Oncology

Referenced Brand - Somatuline®  Depot

Dosage Form - PFS

Approval - Q1’26*

Launch - Q1’26

Lenalidomide

Therapeutic Area - Oncology

Referenced Brand - Revlimid®

Dosage Form - Capsule

Approval - Q1’25

Launch - Q1’26

Romidepsin injection

Therapeutic Area - Oncology

Referenced Brand - Romidepsin

Dosage Form - Vial

Approval - Q1’26*

Launch - Q1’26

Cyclosporine

Therapeutic Area - Ophthalmology

Referenced Brand - Restasis®

Dosage Form - Ophthalmic

Approval - Q4’25*

Launch - Q1’26

Beclomethasone dipropionate

Therapeutic Area - Respiratory

Referenced Brand - QVAR®

Dosage Form - Inhalation

Approval - Q4’25

Launch - Q1’26

Launch Date / Anticipated Launch Date

Undisclosed

Rifaximin

Therapeutic Area - Gastroenterology

Referenced Brand - Xifaxan®

Dosage Form - Tablet

Approval - Q1’25

Launch - Undisclosed

Omalizumab biosimilar

Therapeutic Area - Immunology/Allergy

Referenced Brand - XOLAIR®

Dosage Form - PFS

Approval - Q3’26*

Launch - Undisclosed

Sodium oxybate

Therapeutic Area - Neurology

Referenced Brand - Xyrem®

Dosage Form - Oral solution

Approval - Q3’25

Launch - Undisclosed

Bimatoprost

Therapeutic Area - Ophthalmology

Referenced Brand - Lumigan®

Dosage Form - Ophthalmic

Approval - Q3’25

Launch - Undisclosed

Denosumab biosimilars

Therapeutic Area - Osteoporosis/Bone Cancer

Referenced Brand - PROLIA® & XGEVA®

Dosage Form - Vial

Approval - Q4’25*

Launch - Undisclosed

Albuterol sulfate

Therapeutic Area Respiratory

Referenced Brand - ProAir® HFA

Dosage Form - Inhalation

Approval - Q4’25*

Launch - Undisclosed

 
 

Note: Selected new product launches listed. Additional opportunities not disclosed. All trademarks are the property of their respective owners.
PFS = Prefilled Syringe; MDV = Multiple-dose vial; RTU = Ready-to-use; SDV = Single-dose vial; BLA = Biologics License Application.

*Not yet approved, estimated approval date