Patent and Exclusivity Expirations Report

Report generated for the week of 2025-03-24 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 10 drugs in the patent and exclusivity list. They are:

• Adasuve by Alexza Pharmaceuticals, containing active ingredient Loxapine
• Contrave by Nalpropion Pharmaceuticals, containing active ingredient Bupropion Hydrochloride and Naltrexone Hydrochloride
• Protonix by Wyeth Pharmaceuticals, containing active ingredient Pantoprazole Sodium
• Oxycontin by Purdue Pharma, containing active ingredient Oxycodone Hydrochloride
• Fintepla by UCB Inc, containing active ingredient Fenfluramine Hydrochloride
• Zeposia by Bristol Myers Squibb, containing active ingredient Ozanimod Hydrochloride
• Tlando by Verity Pharmaceuticals, containing active ingredient Testosterone Undecanoate
• Ozempic by Novo Nordisk, containing active ingredient Semaglutide
• Cabenuva Kit by ViiV Healthcare, containing active ingredients Cabotegravir and Rilpivirine
• Vocabria by ViiV Healthcare, containing active ingredient Cabotegravir Sodium

Patents Expiring This Week

BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - CONTRAVE

From NALPROPION PHARMACEUTICALS LLC; to help manage weight in obese or overweight adults with weight-related medical problems.

90MG;8MG

Approved in Sep 10, 2014, used as Reference Listed Drug and Reference Standard

There are 18 future patent(s) for this application. The earliest expires on 2027-06-04, and the latest expires on 2034-07-02.

Patent No	Patent Expiration Date	Patent Title
7375111	2025-03-26	Compositions for affecting weight loss

OXYCODONE - CAPSULE, EXTENDED RELEASE;ORAL - XTAMPZA ER

From COLLEGIUM PHARMACEUTICAL INC; to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

9MG; 13.5MG; 18MG; 27MG

Approved in Apr 26, 2016, used as Reference Listed Drug

36MG

Approved in Apr 26, 2016, used as Reference Listed Drug and Reference Standard

There are 8 future patent(s) for this application. The earliest expires on 2025-06-10, and the latest expires on 2036-09-02.

Patent No	Patent Expiration Date	Patent Title
8449909	2025-03-24	Abuse-deterrent drug formulations
7399488	2025-03-24	Abuse-deterrent pharmaceutical compositions of opiods and other drugs
7771707	2025-03-24	Abuse-deterrent drug formulations

OXYCODONE HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - OXYCONTIN

From PURDUE PHARMA LP; an opioid (narcotic) pain medication used to relieve severe ongoing pain that is not controlled by other pain treatments

10MG; 15MG; 20MG; 30MG; 60MG; 80MG

Approved in Apr 5, 2010, used as Reference Listed Drug

40MG

Approved in Apr 5, 2010, used as Reference Listed Drug and Reference Standard

There are 13 future patent(s) for this application. The earliest expires on 2027-08-24, and the latest expires on 2030-03-29.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
9522919			2025-03-30	Oxycodone compositions
9073933			2025-03-30	Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
10407434			2025-03-30	Process for preparing oxycodone compositions
12060361	U-1556	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE	2025-03-30	Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
10696684			2025-03-30	Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone

PANTOPRAZOLE SODIUM - FOR SUSPENSION, DELAYED RELEASE;ORAL - PROTONIX

From WYETH PHARMACEUTICALS LLC; to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old.

EQ 40MG BASE

Approved in Nov 14, 2007, used as Reference Listed Drug and Reference Standard

There are 2 future patent(s) for this application. The earliest expires on 2026-06-07, and the latest expires on 2026-12-07.

Patent No	Patent Expiration Date	Patent Title
7550153*PED	2025-03-30	Pantoprazole multiparticulate formulations
7838027*PED	2025-03-30	Pantoprazole multiparticulate formulations
7553498*PED	2025-03-30	Pantoprazole multiparticulate formulations

Exclusivities Expiring This Week

CABOTEGRAVIR SODIUM - TABLET;ORAL - VOCABRIA

From VIIV HEALTHCARE CO; an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying.

EQ 30MG BASE

Approved in Jan 21, 2021, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-01-21, and the latest expires on 2026-01-21.

Exclusivity Date	Exclusivity Use Definition
2025-03-29	NEW PATIENT POPULATION

CABOTEGRAVIR; RILPIVIRINE - SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - CABENUVA KIT

From VIIV HEALTHCARE CO; long-acting HIV treatment used to keep HIV levels undetectable in patients 12 years and older.

400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)

600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)

Approved in Jan 21, 2021, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-01-21, and the latest expires on 2026-01-21.

Exclusivity Date	Exclusivity Use Definition
2025-03-29	NEW PATIENT POPULATION

FENFLURAMINE HYDROCHLORIDE - SOLUTION;ORAL - FINTEPLA

From UCB INC; to treat the seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

EQ 2.2MG BASE/ML

Approved in Jun 25, 2020, used as Reference Listed Drug and Reference Standard

There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-09-25, and the latest expires on 2029-09-25.

Exclusivity Date	Exclusivity Use Definition
2025-03-25	INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER

OZANIMOD HYDROCHLORIDE - CAPSULE;ORAL - ZEPOSIA

From BRISTOL MYERS SQUIBB CO; to treat adults with types relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC)

EQ 0.23MG BASE; EQ 0.46MG BASE

Approved in Mar 25, 2020, used as Reference Listed Drug

EQ 0.92MG BASE

Approved in Mar 25, 2020, used as Reference Listed Drug and Reference Standard

There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-08-30, and the latest expires on 2027-08-30.

Exclusivity Date	Exclusivity Use Definition
2025-03-25	NEW CHEMICAL ENTITY

SEMAGLUTIDE - SOLUTION;SUBCUTANEOUS - OZEMPIC

From NOVO NORDISK INC; used to help adults with type 2 diabetes manage blood sugar levels. It is also prescribed to reduce the risk of kidney function decline in chronic kidney disease (CKD) and lower cardiovascular risks in certain patients with type 2 diabetes.

Unibest offers a one-stop Semaglutide development package from Semaglutide intermediates to Semaglutide API and FDF, including Semaglutide tablets. Contact us today to discuss how we can support you to get into the GLP-1 market.

8MG/3ML (2.68MG/ML)

Approved in Mar 28, 2022, used as Reference Listed Drug and Reference Standard

There is 1 future exclusivity(ies) for this drug product. The earliest expires on 2028-01-28, and the latest expires on 2028-01-28.

Exclusivity Date	Exclusivity Use Definition
2025-03-28	ADDITION OF A 3RD MAINTENANCE DOSE OF SEMAGLUTIDE

TESTOSTERONE UNDECANOATE - CAPSULE;ORAL - TLANDO

From VERITY PHARMACEUTICALS INC; a liquid filled capsule used to treat symptoms of low testosterone in men who have hypogonadism

112.5MG

Approved in Mar 28, 2022, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-03-28	NEW PRODUCT