Drugs facing NCE-1 in 2024
Drugs becoming eligible for first Paragraph IV ANDA filing in 2024
1. Artesunate patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US12121506 | AMIVAS | Artesunate powders, pharmaceutical compositions and methods of manufacture |
Feb, 2044
(17 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 26, 2025 |
| Orphan Drug Exclusivity(ODE-290) | May 26, 2027 |
Drugs and Companies using ARTESUNATE ingredient
NCE-1 date: 26 May, 2024
Market Authorisation Date: 26 May, 2020
Treatment: NA
Dosage: POWDER
More Information on Dosage
ARTESUNATE family patents
2. Ayvakit 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. | ||||
| US9944651 | BLUEPRINT MEDICINES | Compositions useful for treating disorders related to kit |
Oct, 2034
(8 years from now) | |
| US9994575 | BLUEPRINT MEDICINES | Compositions useful for treating disorders related to kit |
Oct, 2034
(8 years from now) | |
| US9200002 | BLUEPRINT MEDICINES | Compositions useful for treating disorders related to KIT |
Oct, 2034
(8 years from now) | |
| US11827642 | BLUEPRINT MEDICINES | Compositions useful for treating disorders related to KIT |
Oct, 2034
(8 years from now) | |
| US11964980 | BLUEPRINT MEDICINES | Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making |
Apr, 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). | ||||
| US11999744 | BLUEPRINT MEDICINES | Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making |
Apr, 2040
(14 years from now) | |
| US12252494 | BLUEPRINT MEDICINES | Dosing regimens of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine for treatment of indolent systemic mastocytosis |
Apr, 2040
(14 years from now) | |
| US12060354 | BLUEPRINT MEDICINES | Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making |
Mar, 2042
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-863) | Jun 16, 2024 |
| New Indication(I-864) | Jun 16, 2024 |
| New Chemical Entity Exclusivity(NCE) | Jan 09, 2025 |
| New Indication(I-912) | May 22, 2026 |
| Orphan Drug Exclusivity(ODE-366) | Jan 09, 2027 |
| Orphan Drug Exclusivity(ODE-356) | Jun 16, 2028 |
| Orphan Drug Exclusivity(ODE-434) | May 22, 2030 |
Drugs and Companies using AVAPRITINIB ingredient
NCE-1 date: 10 January, 2024
Market Authorisation Date: 16 June, 2021
Treatment: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with an associated hematological neoplasm (sm-ahn), and mast cell leu...
Dosage: TABLET
More Information on Dosage
AYVAKIT family patents
3. Barhemsys patent
expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US10525033 | ACACIA | Use of amisulpride as an anti-emetic |
Mar, 2031
(4 years from now) | |
| US9889118 | ACACIA | Use of amisulpride as an anti-emetic |
Mar, 2031
(4 years from now) | |
| US9545426 | ACACIA | Use of amisulpride as an anti-emetic |
Mar, 2031
(4 years from now) | |
| US12194022 | ACACIA | Use of amisulpride as an anti-emetic |
Mar, 2031
(4 years from now) | |
| US9084765 | ACACIA | Use of amisulpride as an anti-emetic |
Feb, 2034
(7 years from now) | |
| US12005042 | ACACIA | Rescue treatment of post operative nausea and vomiting |
Feb, 2038
(11 years from now) | |
| US11357753 | ACACIA | Rescue treatment of post operative nausea and vomiting |
Feb, 2038
(11 years from now) | |
| US12329740 | ACACIA | Rescue treatment of post operative nausea and vomiting |
Feb, 2038
(11 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 26, 2025 |
Drugs and Companies using AMISULPRIDE ingredient
NCE-1 date: 27 February, 2024
Market Authorisation Date: 26 February, 2020
Treatment: Prevention of post-operative nausea and vomiting; Prevention and treatment of post-operative nausea and vomiting; Treatment of post-operative nausea and vomiting
Dosage: SOLUTION
More Information on Dosage
BARHEMSYS family patents
4. Brilinta patent expiration
BRILINTA'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. | ||||
| US6251910 | ASTRAZENECA | 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists |
Jul, 2018
(7 years ago) | |
| US6525060 | ASTRAZENECA | Triazolo(4,5-d)pyrimidine compounds |
Dec, 2019
(6 years ago) | |
| US7250419 | ASTRAZENECA | Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition |
Dec, 2019
(6 years ago) | |
| US7265124 | ASTRAZENECA | Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound |
Jul, 2021
(4 years ago) | |
| USRE46276 | ASTRAZENECA | Triazolo(4,5-D)pyrimidine compounds |
Oct, 2024
(1 year, 4 months ago) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US6251910 | ASTRAZENECA | 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists |
Jul, 2018
(7 years ago) | |
| US6525060 | ASTRAZENECA | Triazolo(4,5-d)pyrimidine compounds |
Dec, 2019
(6 years ago) | |
| US7250419 | ASTRAZENECA | Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition |
Dec, 2019
(6 years ago) | |
| US7265124 | ASTRAZENECA | Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound |
Jul, 2021
(4 years ago) | |
|
USRE46276 (Pediatric) | ASTRAZENECA | Triazolo(4,5-D)pyrimidine compounds |
Apr, 2025
(10 months ago) | |
| US8425934 | ASTRAZENECA | Pharmaceutical compositions |
Apr, 2030
(4 years from now) | |
|
US8425934 (Pediatric) | ASTRAZENECA | Pharmaceutical compositions |
Oct, 2030
(4 years from now) | |
| US10300065 | ASTRAZENECA | Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction |
Jan, 2036
(9 years from now) | |
|
US10300065 (Pediatric) | ASTRAZENECA | Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction |
Jul, 2036
(10 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2016 |
| New Indication(I-714) | Sep 03, 2018 |
| New Strength(NS) | Sep 03, 2018 |
| New Indication(I-851) | May 28, 2023 |
| New Indication(I-848) | Nov 05, 2023 |
| M(M-283) | May 09, 2025 |
| Pediatric Exclusivity(PED) | Nov 09, 2025 |
Drugs and Companies using TICAGRELOR ingredient
NCE-1 date: 09 November, 2024
Market Authorisation Date: 03 September, 2015
Treatment: Reduction of the rate of thrombotic events in patients with acute coronary syndrome; Reducing the rate of cardiovascular death, myocardial infarction, and stroke in a patient receiving 75-100 mg aspir...
Dosage: TABLET
How can I launch a generic of BRILINTA before its drug patent expiration?
More Information on Dosage
BRILINTA family patents
5. Byfavo patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US10961250 | ACACIA | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(1 year, 3 months from now) | |
| US9777007 | ACACIA | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(1 year, 3 months from now) | |
| US10472365 | ACACIA | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(1 year, 3 months from now) | |
| US9914738 | ACACIA | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(1 year, 3 months from now) | |
| US10052334 | ACACIA | Dosing regimen for sedation with CNS 7056 (remimazolam) |
Nov, 2031
(5 years from now) | |
| US9737547 | ACACIA | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Nov, 2031
(5 years from now) | |
| US10342800 | ACACIA | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Nov, 2031
(5 years from now) | |
| US10195210 | ACACIA | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Nov, 2031
(5 years from now) | |
| US10722522 | ACACIA | Dosing regimen for sedation with CNS 7056 (remimazolam) |
Nov, 2031
(5 years from now) | |
| US9561236 | ACACIA | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Apr, 2033
(7 years from now) | |
| US9827251 | ACACIA | Dosing regimen for sedation with CNS 7056 (remimazolam) |
Jan, 2034
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 06, 2025 |
Drugs and Companies using REMIMAZOLAM BESYLATE ingredient
NCE-1 date: 06 October, 2024
Market Authorisation Date: 06 October, 2020
Treatment: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Dosage: POWDER
How can I launch a generic of BYFAVO before its drug patent expiration?
More Information on Dosage
BYFAVO family patents
6. Dayvigo 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. | ||||
| US8268848 | EISAI | Cyclopropane compound |
Sep, 2031
(5 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). | ||||
| US10188652 | EISAI | Compositions and methods for treating insomnia |
Oct, 2035
(9 years from now) | |
| US11026944 | EISAI | Compositions and methods for treating insomnia |
Oct, 2035
(9 years from now) | |
| US10702529 | EISAI | Compositions and methods for treating insomnia |
Oct, 2035
(9 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 07, 2025 |
| M(M-293) | Apr 20, 2026 |
Drugs and Companies using LEMBOREXANT ingredient
NCE-1 date: 07 April, 2024
Market Authorisation Date: 07 April, 2020
Treatment: Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance
Dosage: TABLET
More Information on Dosage
DAYVIGO family patents
7. Detectnet patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US10159759 | CURIUM | Pet tracer for imaging of neuroendocrine tumors |
Aug, 2032
(6 years from now) | |
| US11160888 | CURIUM | PET tracer for imaging of neuroendocrine tumors |
Aug, 2032
(6 years from now) | |
| US10383961 | CURIUM | PET tracer for imaging of neuroendocrine tumors |
Jul, 2033
(7 years from now) | |
| US12102696 | CURIUM | Radiolabeling and formulation for scale up of 64Cu-DOTATATE |
Sep, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 03, 2025 |
| Orphan Drug Exclusivity(ODE-317) | Sep 03, 2027 |
Drugs and Companies using COPPER CU-64 DOTATATE ingredient
NCE-1 date: 03 September, 2024
Market Authorisation Date: 03 September, 2020
Treatment: Use of cu-64 dotatate with positron emission tomography (pet) for localization of somatostatin receptor positive neuroendocrine tumors (nets) in adult patients
Dosage: SOLUTION
More Information on Dosage
DETECTNET family patents
8. Dojolvi patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9186344 | ULTRAGENYX | Glycogen or polysaccharide storage disease treatment method |
Jul, 2025
(8 months ago) | |
| US8697748 | ULTRAGENYX | Glycogen or polysaccharide storage disease treatment method |
Apr, 2029
(3 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 30, 2025 |
| Orphan Drug Exclusivity(ODE-311) | Jun 30, 2027 |
Drugs and Companies using TRIHEPTANOIN ingredient
NCE-1 date: 30 June, 2024
Market Authorisation Date: 30 June, 2020
Treatment: NA
Dosage: LIQUID
How can I launch a generic of DOJOLVI before its drug patent expiration?
More Information on Dosage
DOJOLVI family patents
9. Evrysdi 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. | ||||
| US9586955 | GENENTECH | Compounds for treating spinal muscular atrophy |
Feb, 2033
(6 years from now) | |
| US9969754 | GENENTECH | Compounds for treating spinal muscular atrophy |
May, 2035
(9 years from now) | |
| US12122789 | GENENTECH | Forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making |
Apr, 2041
(15 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). | ||||
| US11827646 | GENENTECH | Compounds for treating spinal muscular atrophy |
Jan, 2036
(9 years from now) | |
| US11938136 | GENENTECH | Compositions for treating spinal muscular atrophy |
Nov, 2036
(10 years from now) | |
| US12350273 | GENENTECH | Treatment Of Sma |
Oct, 2038
(12 years from now) | |
| US11534444 | GENENTECH | Treatment of SMA |
Oct, 2038
(12 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | May 27, 2025 |
| New Chemical Entity Exclusivity(NCE) | Aug 07, 2025 |
| M(M-270) | Oct 03, 2026 |
| Orphan Drug Exclusivity(ODE-334) | Aug 07, 2027 |
| Orphan Drug Exclusivity(ODE-400) | May 27, 2029 |
Drugs and Companies using RISDIPLAM ingredient
NCE-1 date: 07 August, 2024
Market Authorisation Date: 07 August, 2020
Treatment: Treatment of spinal muscular atrophy
Dosage: FOR SOLUTION; TABLET
How can I launch a generic of EVRYSDI before its drug patent expiration?
More Information on Dosage
EVRYSDI family patents
10. Gavreto 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. | ||||
| US10030005 | RIGEL | Inhibitors of RET |
Nov, 2036
(10 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). | ||||
| US11963958 | RIGEL | RET inhibitor for use in treating cancer having a RET alteration |
Apr, 2039
(13 years from now) | |
| US11273160 | RIGEL | RET inhibitor for use in treating cancer having a RET alteration |
Apr, 2039
(13 years from now) | |
| US11872192 | RIGEL | RET inhibitor for use in treating cancer having a RET alteration |
Apr, 2039
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 04, 2025 |
| Orphan Drug Exclusivity(ODE-318) | Sep 04, 2027 |
| Orphan Drug Exclusivity(ODE-340) | Dec 01, 2027 |
| Orphan Drug Exclusivity(ODE-341) | Dec 01, 2027 |
Drugs and Companies using PRALSETINIB ingredient
NCE-1 date: 04 September, 2024
Market Authorisation Date: 04 September, 2020
Treatment: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractor...
Dosage: CAPSULE
More Information on Dosage
GAVRETO family patents