Patent and Exclusivity Expirations Report

Report generated for the week of 2025-02-10 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 6 drugs in the patent and exclusivity list. They are:
- Tudorza Pressair by Covis Pharma GMBH, containing active ingredient Aclidinium Bromide

- Duaklir Pressair by Covis Pharma GMBH, containing active ingredient Aclidinium Bromide and Formoterol Fumarate

- Scenesse by Clinuvel Inc, containing active ingredient Afamelanotide

- Hysingla ER by Purdue Pharma LP, containing active ingredient Hydrocodone Bitartrate

- Izervay by Astellas Pharma US Inc, containing active ingredient Avacincaptad Pegol Sodium

- Symdeko by Vertex Pharmaceuticals Inc, containing active ingredient Ivacaftor and Tezacaftor

Patents Expiring This Week

ACLIDINIUM BROMIDE - POWDER, METERED;INHALATION - TUDORZA PRESSAIR

From COVIS PHARMA GMBH; for prevention of bronchospasm in adults with chronic bronchitis, emphysema, or other forms of COPD.

0.4MG/INH

Approved in Jul 23, 2012, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2027-04-22, and the latest expires on 2029-03-13.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
RE46417	U-2513	Maintenance treatment of chronic obstructive pulmonary disease (COPD)	2025-02-10	Quinuclidine derivatives and their use as muscarinic M3 receptor ligands

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE - POWDER, METERED;INHALATION - DUAKLIR PRESSAIR

From COVIS PHARMA GMBH; for prevention of airflow obstruction and reduce flare-ups in adults with COPD, including bronchitis and emphysema.

0.4MG/INH;0.012MG/INH

Approved in Mar 29, 2019, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2027-04-22, and the latest expires on 2029-03-13.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
RE46417	U-2513	Maintenance treatment of chronic obstructive pulmonary disease (COPD)	2025-02-10	Quinuclidine derivatives and their use as muscarinic M3 receptor ligands

AFAMELANOTIDE - IMPLANT;SUBCUTANEOUS - SCENESSE

From CLINUVEL INC; to prevent sun-induced skin damage in patients with a rare type of disorder, erythropoietic protoporphyria (EPP).

16MG

Approved in Oct 8, 2019, used as Reference Listed Drug and Reference Standard

There are 1 future patent(s) for this application. The earliest expires on 2029-03-11, and the latest expires on 2029-03-11.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
10076555	U-2638	Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)	2025-02-11	Methods of inducing melanogenesis in a subject

AVACINCAPTAD PEGOL SODIUM - SOLUTION;INTRAVITREAL - IZERVAY

From ASTELLAS PHARMA US INC; an RNA aptamer inhibiting the complement C5 indicated for the treatment of geographic atrophy secondary to age-related macular degeneration.

EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)

Approved in Aug 4, 2023, used as Reference Listed Drug and Reference Standard

There are 4 future patent(s) for this application. The earliest expires on 2026-11-11, and the latest expires on 2034-07-11.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
7803931			2025-02-14	Aptamer therapeutics useful in the treatment of complement-related disorders
7579456			2025-02-14	Aptamer therapeutics useful in the treatment of complement-related disorders
7538211			2025-02-14	Aptamer therapeutics useful in the treatment of complement-related disorders
10947544	U-3673	Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye	2025-02-14	Aptamer therapeutics useful in the treatment of complement-related disorders
9617546	U-3673	Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye	2025-02-14	Aptamer therapeutics useful in the treatment of complement-related disorders

HYDROCODONE BITARTRATE - TABLET, EXTENDED RELEASE;ORAL - HYSINGLA ER

From PURDUE PHARMA LP; to treat severe pain.

20MG

Approved in Nov 20, 2014, used as Reference Listed Drug and Reference Standard

30MG; 40MG; 60MG; 80MG; 100MG; 120MG

Approved in Nov 20, 2014, used as Reference Listed Drug

There are 19 future patent(s) for this application. The earliest expires on 2027-08-24, and the latest expires on 2031-12-21.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
11844865	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	2025-02-13	Abuse-proofed oral dosage form

Exclusivities Expiring This Week

IVACAFTOR; IVACAFTOR, TEZACAFTOR - TABLET;ORAL - SYMDEKO (COPACKAGED)

From VERTEX PHARMACEUTICALS INC; to treat cystic fibrosis in adults and children who are at least 6 years old.

Vertex Pharmaceuticals has also developed TRIKAFTA and TRIKAFTA (COPACKAGED) with these Ivacatfor and Tezacaftor, and in the issue of 2024-10-21, exclusivity of New Chemical Entity has expired.

150MG;150MG, 100MG

Approved in Feb 12, 2018, used as Reference Listed Drug and Reference Standard

75MG;75MG, 50MG

Approved in Jun 21, 2019, used as Reference Listed Drug

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2026-06-21, and the latest expires on 2027-12-21.

Exclusivity Date	Exclusivity Use Definition
2025-02-12	Treatment of patients with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene responsive to tezacaftor/ivacaftor