Drugs facing NCE-1 in 2025
Drugs becoming eligible for first Paragraph IV ANDA filing in 2025
1. Amondys 45 patent expiration
AMONDYS 45's oppositions filed in EPO
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US9416361 | SAREPTA | Splice-region antisense composition and method |
May, 2021
(4 years ago) | |
| US9447415 | SAREPTA | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months ago) | |
| US8524880 | SAREPTA | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Apr, 2026
(10 days from now) | |
| USRE48960 | SAREPTA | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Feb, 2029
(2 years from now) | |
| US9228187 | SAREPTA | Antisense molecules and methods for treating pathologies |
Nov, 2030
(4 years from now) | |
| US10287586 | SAREPTA | Antisense molecules and methods for treating pathologies |
Nov, 2030
(4 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US10533174 | SAREPTA | Splice-region antisense composition and method |
May, 2021
(4 years ago) | |
| US9758783 | SAREPTA | Antisense molecules and methods for treating pathologies |
Nov, 2030
(4 years from now) | |
| US10781450 | SAREPTA | Antisense molecules and methods for treating pathologies |
Nov, 2030
(4 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 25, 2026 |
| Orphan Drug Exclusivity(ODE-347) | Feb 25, 2028 |
Drugs and Companies using CASIMERSEN ingredient
NCE-1 date: 25 February, 2025
Market Authorisation Date: 25 February, 2021
Treatment: Treatment of duchenne muscular dystrophy (dmd) in patients who have a mutation of the dmd gene that is amenable to exon 45 skipping by restoring an mrna reading frame to induce dystrophin protein prod...
Dosage: SOLUTION
More Information on Dosage
AMONDYS 45 family patents
2. Apretude patent expiration
APRETUDE's oppositions filed in EPO
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US10927129 | VIIV | N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity |
Apr, 2026
(a month from now) | |
| US8410103 | VIIV | (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent |
Feb, 2031
(4 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US12138264 | VIIV | Pharmaceutical compositions |
Sep, 2031
(5 years from now) | |
| US11224597 | VIIV | Pharmaceutical compositions |
Sep, 2031
(5 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2026 |
Drugs and Companies using CABOTEGRAVIR ingredient
NCE-1 date: 21 January, 2025
Market Authorisation Date: 20 December, 2021
Treatment: NA
Dosage: SUSPENSION, EXTENDED RELEASE
More Information on Dosage
APRETUDE family patents
3. Azstarys patent
expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US10584112 | COMMAVE | Methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(11 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9079928 | COMMAVE | Methylphenidate-oxoacid conjugates, processes of making and using the same |
Jul, 2032
(6 years from now) | |
| US10584113 | COMMAVE | Methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(11 years from now) | |
| US10759778 | COMMAVE | Methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(11 years from now) | |
| US10954213 | COMMAVE | Compositions comprising methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(11 years from now) | |
| US10858341 | COMMAVE | Compositions comprising methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(11 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 07, 2026 |
NCE-1 date: 07 May, 2025
Market Authorisation Date: 07 May, 2021
Treatment: Treatment of attention-deficit hyperactivity disorder (adhd) with serdexmethylphenidate and dexmethylphenidate
Dosage: CAPSULE
More Information on Dosage
AZSTARYS family patents
4. Brexafemme patent expiration
BREXAFEMME's oppositions filed in EPO
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US8188085 | GLAXOSMITHKLINE | Antifungal agents |
Aug, 2030
(4 years from now) | |
| US10927142 | GLAXOSMITHKLINE | Salts and polymorphs of SCY-078 |
Jan, 2035
(8 years from now) | |
| US10174074 | GLAXOSMITHKLINE | Salts and polymorphs of SCY-078 |
Jan, 2035
(8 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US10370406 | GLAXOSMITHKLINE | Salts and polymorphs of SCY-078 |
Jan, 2035
(8 years from now) | |
| US11534433 | GLAXOSMITHKLINE | Antifungal agents with enhanced activity in acidic pH |
Jun, 2039
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-903) | Nov 30, 2025 |
| New Chemical Entity Exclusivity(NCE) | Jun 01, 2026 |
| Generating Antibiotic Incentives Now(GAIN) | Jun 01, 2031 |
Drugs and Companies using IBREXAFUNGERP CITRATE ingredient
NCE-1 date: 01 June, 2025
Market Authorisation Date: 01 June, 2021
Treatment: Treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (vvc); Reduction in the incidence of recurrent vulvovaginal candidiasis (rvvc) in adult and post-menarchal pediatr...
Dosage: TABLET
More Information on Dosage
BREXAFEMME family patents
5. Bylvay patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US7132416 | IPSEN | Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia |
Sep, 2022
(3 years ago) | |
| US10975046 | IPSEN | Crystal modifications of odevixibat |
Jun, 2039
(13 years from now) | |
| US12091394 | IPSEN | Crystal modifications of odevixibat |
Jun, 2039
(13 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US12545705 | IPSEN | Ibat Inhibitors For The Treatment Of Liver Diseases |
Nov, 2031
(5 years from now) | |
| US10011633 | IPSEN | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(5 years from now) | |
| US11732006 | IPSEN | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(5 years from now) | |
| US12187812 | IPSEN | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(5 years from now) | |
| US9694018 | IPSEN | IBAT inhibitors for the treatment of liver disease |
Nov, 2031
(5 years from now) | |
| US10093697 | IPSEN | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(5 years from now) | |
| US10487111 | IPSEN | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(5 years from now) | |
| US10981952 | IPSEN | IBAT inhibitors for the treatment of liver diseases |
Nov, 2031
(5 years from now) | |
| US11801226 | IPSEN | Pharmaceutical formulation of odevixibat |
Jun, 2039
(13 years from now) | |
| US11802115 | IPSEN | Pharmaceutical formulation of odevixibat |
Jun, 2039
(13 years from now) | |
| US12508234 | IPSEN | Pharmaceutical Formulation Of Odevixibat |
Jun, 2039
(13 years from now) | |
| US11365182 | IPSEN | Crystal modifications of odevixibat |
Jun, 2039
(13 years from now) | |
| US12447156 | IPSEN | Treating Progressive Familial Intrahepatic Cholestasis (Pfic) With Ibat Inhibitors |
Nov, 2041
(15 years from now) | |
| US11583539 | IPSEN | Treating progressive familial intrahepatic cholestasis (PFIC) with IBAT inhibitors |
Nov, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-918) | Jun 13, 2026 |
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2026 |
| Orphan Drug Exclusivity(ODE-363) | Jul 20, 2028 |
| Orphan Drug Exclusivity(ODE-436) | Jun 13, 2030 |
Drugs and Companies using ODEVIXIBAT ingredient
NCE-1 date: 20 July, 2025
Market Authorisation Date: 20 July, 2021
Treatment: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (algs); Method of treating pruritus in patients 3 months or older suffering from progressive fam...
Dosage: CAPSULE; CAPSULE, PELLETS
More Information on Dosage
BYLVAY family patents
6. Cabenuva Kit patent expiration
CABENUVA KIT's oppositions filed in EPO
CABENUVA KIT IPR and PTAB Proceedings
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US6838464 | VIIV | 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents |
Feb, 2021
(5 years ago) | |
| US8080551 | VIIV | HIV inhibiting pyrimidines derivatives |
Apr, 2023
(2 years ago) | |
| US7125879 | VIIV | HIV inhibiting pyrimidines derivatives |
Apr, 2025
(10 months ago) | |
| US10927129 | VIIV | N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity |
Apr, 2026
(a month from now) | |
| US8410103 | VIIV | (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent |
Feb, 2031
(4 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11389447 | VIIV | Aqueous suspensions of TMC278 |
Jun, 2027
(1 year, 3 months from now) | |
| US12138264 | VIIV | Pharmaceutical compositions |
Sep, 2031
(5 years from now) | |
| US11224597 | VIIV | Pharmaceutical compositions |
Sep, 2031
(5 years from now) | |
| USRE50189 | VIIV | Long term treatment of HIV-infection with TMC278 |
Nov, 2031
(5 years from now) | |
| US11389448 | VIIV | Freeze dried drug nanosuspensions |
Apr, 2032
(6 years from now) | |
| US12178815 | VIIV | Regimens for treating HIV infections and aids |
Jul, 2038
(12 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-184) | Jan 31, 2025 |
| New Patient Population(NPP) | Mar 29, 2025 |
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2026 |
Drugs and Companies using CABOTEGRAVIR; RILPIVIRINE ingredient
NCE-1 date: 21 January, 2025
Market Authorisation Date: 21 January, 2021
Treatment: Treatment of hiv-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg by monthly administration of rilpivirine suspension as part of combination therapy; Treatme...
Dosage: SUSPENSION, EXTENDED RELEASE
More Information on Dosage
CABENUVA KIT family patents
7. Cosela patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US10189849 | PHARMACOSMOS | CDK inhibitors |
Oct, 2031
(5 years from now) | |
| US8598197 | PHARMACOSMOS | CDK inhibitors |
Oct, 2031
(5 years from now) | |
| US9957276 | PHARMACOSMOS | CDK inhibitors |
Oct, 2031
(5 years from now) | |
| US8598186 | PHARMACOSMOS | CDK inhibitors |
Dec, 2034
(8 years from now) | |
| US12168666 | PHARMACOSMOS | Morphic forms of trilaciclib and methods of manufacture thereof |
Nov, 2040
(14 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11040042 | PHARMACOSMOS | Transient protection of normal cells during chemotherapy |
Oct, 2031
(5 years from now) | |
| US10927120 | PHARMACOSMOS | CDK inhibitors |
Oct, 2031
(5 years from now) | |
| US10189850 | PHARMACOSMOS | CDK inhibitors |
Oct, 2031
(5 years from now) | |
| US10085992 | PHARMACOSMOS | Transient protection of normal cells during chemotherapy |
Mar, 2034
(7 years from now) | |
| US11717523 | PHARMACOSMOS | Transient protection of normal cells during chemotherapy |
Mar, 2034
(7 years from now) | |
| US10966984 | PHARMACOSMOS | Transient protection of normal cells during chemotherapy |
Mar, 2034
(7 years from now) | |
| US9487530 | PHARMACOSMOS | Transient protection of normal cells during chemotherapy |
Mar, 2034
(7 years from now) | |
| US12527798 | PHARMACOSMOS | NA |
Dec, 2037
(11 years from now) | |
| US11529352 | PHARMACOSMOS | Preservation of immune response during chemotherapy regimens |
Jul, 2039
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 12, 2026 |
Drugs and Companies using TRILACICLIB DIHYDROCHLORIDE ingredient
NCE-1 date: 12 February, 2025
Market Authorisation Date: 12 February, 2021
Treatment: A method to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a carboplatin and etoposide-containing regimen for extensive-stage small cell l...
Dosage: POWDER
How can I launch a generic of COSELA before its drug patent expiration?
More Information on Dosage
COSELA family patents
8. Cytalux patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US9061057 | ON TARGET | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(7 years from now) | |
| US9341629 | ON TARGET | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(7 years from now) | |
| US9333270 | ON TARGET | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(7 years from now) | |
| US9789208 | ON TARGET | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(7 years from now) | |
| US10881747 | ON TARGET | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(7 years from now) | |
| US9254341 | ON TARGET | Methods of manufacture of pteroyl-amino acid-fluorescent dyes |
Oct, 2033
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-905) | Dec 16, 2025 |
| New Chemical Entity Exclusivity(NCE) | Nov 29, 2026 |
| Orphan Drug Exclusivity(ODE-390) | Nov 29, 2028 |
Drugs and Companies using PAFOLACIANINE SODIUM ingredient
NCE-1 date: 29 November, 2025
Market Authorisation Date: 29 November, 2021
Treatment: Cytalux is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions
Dosage: SOLUTION
More Information on Dosage
CYTALUX family patents
9. Empaveli patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US9169307 | APELLIS | Potent compstatin analogs |
Nov, 2027
(1 year, 7 months from now) | |
| US7888323 | APELLIS | Potent compstatin analogs |
Dec, 2027
(1 year, 8 months from now) | |
| US7989589 | APELLIS | Compstatin analogs with improved activity |
Dec, 2027
(1 year, 8 months from now) | |
| US11661441 | APELLIS | Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof |
Jan, 2033
(6 years from now) | |
| US10125171 | APELLIS | Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof |
Aug, 2033
(7 years from now) | |
| US10035822 | APELLIS | Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods |
Nov, 2033
(7 years from now) | |
| US10875893 | APELLIS | Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods |
Nov, 2033
(7 years from now) | |
| US11292815 | APELLIS | Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods |
Nov, 2033
(7 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11040107 | APELLIS | Dosing regimens and related compositions and methods |
Apr, 2038
(12 years from now) | |
| US11844841 | APELLIS | Dosing regimens and related compositions and methods |
Dec, 2038
(12 years from now) | |
| US12290566 | APELLIS | Dosing regimens and related compositions and methods |
Dec, 2038
(12 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-288) | Feb 08, 2026 |
| New Chemical Entity Exclusivity(NCE) | May 14, 2026 |
| Orphan Drug Exclusivity(ODE-351) | May 14, 2028 |
| New Indication(I-972) | Jul 28, 2028 |
Drugs and Companies using PEGCETACOPLAN ingredient
NCE-1 date: 14 May, 2025
Market Authorisation Date: 14 May, 2021
Treatment: Treatment of adult and pediatric patients aged 12 years and older weighing 50 kg or higher with c3 glomerulopathy or primary immunecomplex membranoproliferative glomerulonephritis by administration of...
Dosage: SOLUTION
More Information on Dosage
EMPAVELI family patents
10. Exkivity patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US9796712 | TAKEDA | Heteroaryl compounds for kinase inhibition |
May, 2035
(9 years from now) | |
| US10227342 | TAKEDA | Heteroaryl compounds for kinase inhibition |
May, 2035
(9 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 15, 2026 |
| Orphan Drug Exclusivity(ODE-374) | Sep 15, 2028 |
Drugs and Companies using MOBOCERTINIB SUCCINATE ingredient
NCE-1 date: 15 September, 2025
Market Authorisation Date: 15 September, 2021
Treatment: Treatment of patients with non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 20 exon insertion mutations whose disease has progressed on or after platinum-based chem...
Dosage: CAPSULE
More Information on Dosage
EXKIVITY family patents