Drugs facing NCE-1 in 2028
Drugs becoming eligible for first Paragraph IV ANDA filing in 2028
1. Alyftrek patent expiration
ALYFTREK'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. | ||||
| US8754224 | VERTEX | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(9 months from now) | |
| US11639347 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 1 month from now) | |
| US10239867 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 1 month from now) | |
| US7645789 | VERTEX | Indole derivatives as CFTR modulators |
May, 2027
(1 year, 2 months from now) | |
| US8623905 | VERTEX | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 2 months from now) | |
| US7495103 | VERTEX | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 2 months from now) | |
| US7776905 | VERTEX | Modulators of ATP-binding cassette transporters |
Jun, 2027
(1 year, 3 months from now) | |
| USRE50453 | VERTEX | NA |
Jul, 2031
(5 years from now) | |
| US9181192 | VERTEX | Deuterated CFTR potentiators |
May, 2032
(6 years from now) | |
| US10047053 | VERTEX | Deuterated CFTR potentiators |
May, 2032
(6 years from now) | |
| US8865902 | VERTEX | Deuterated CFTR potentiators |
May, 2032
(6 years from now) | |
| US9512079 | VERTEX | Deuterated CFTR potentiators |
May, 2032
(6 years from now) | |
| US11066417 | VERTEX | Modulators of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators |
Feb, 2039
(12 years from now) | |
| US11873300 | VERTEX | Crystalline forms of CFTR modulators |
Aug, 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). | ||||
| US8629162 | VERTEX | Modulators of ATP-binding cassette transporters |
Jun, 2025
(8 months ago) | |
| US8354427 | VERTEX | Modulators of ATP-binding cassette transporters |
Jul, 2026
(4 months from now) | |
| US9931334 | VERTEX | Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(9 months from now) | |
| US8410274 | VERTEX | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(9 months from now) | |
| US9670163 | VERTEX | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(9 months from now) | |
| US10022352 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 1 month from now) | |
| US9974781 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 1 month from now) | |
| US8598181 | VERTEX | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 2 months from now) | |
| US8324242 | VERTEX | Modulators of ATP-binding cassette transporters |
Aug, 2027
(1 year, 5 months from now) | |
| US8415387 | VERTEX | Modulators of ATP-binding cassette transporters |
Nov, 2027
(1 year, 8 months from now) | |
| US10646481 | VERTEX | Pharmaceutical composition and administrations thereof |
Aug, 2029
(3 years from now) | |
| US11564916 | VERTEX | Pharmaceutical composition and administrations thereof |
Aug, 2029
(3 years from now) | |
| US11578062 | VERTEX | Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide |
Mar, 2031
(5 years from now) | |
| US10081621 | VERTEX | Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide |
Mar, 2031
(5 years from now) | |
| US9012496 | VERTEX | Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof |
Jul, 2033
(7 years from now) | |
| US10058546 | VERTEX | Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof |
Jul, 2033
(7 years from now) | |
| US10206877 | VERTEX | Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases |
Apr, 2035
(9 years from now) | |
| US11951212 | VERTEX | Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases |
Apr, 2035
(9 years from now) | |
| US11866450 | VERTEX | Modulators of Cystic Fibrosis Transmembrane Conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators |
Feb, 2039
(12 years from now) | |
| US12186306 | VERTEX | Methods of treatment for cystic fibrosis |
Jan, 2043
(16 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 20, 2029 |
Drugs and Companies using DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM ingredient
NCE-1 date: 20 December, 2028
Market Authorisation Date: 20 December, 2024
Treatment: Treatment of a moderate to mild clinical phenotype of cf in patients aged 6 years and older who have at least one f508del mutation or another responsive mutation in the cftr gene with a pharmaceutical...
Dosage: TABLET
More Information on Dosage
ALYFTREK family patents
2. Aqneursa 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). | ||||
| US12433862 | INTRABIO | Pharmaceutical Compositions And Uses Directed To Lysosomal Storage Disorders |
Apr, 2037
(11 years from now) | |
| US12433863 | INTRABIO | Pharmaceutical Compositions And Uses Directed To Lysosomal Storage Disorders |
Apr, 2037
(11 years from now) | |
| US11400067 | INTRABIO | Pharmaceutical compositions and uses directed to lysosomal storage disorders |
Apr, 2037
(11 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 24, 2029 |
| Orphan Drug Exclusivity(ODE-498) | Sep 24, 2031 |
Drugs and Companies using LEVACETYLLEUCINE ingredient
NCE-1 date: 24 September, 2028
Market Authorisation Date: 24 September, 2024
Treatment: Treatment of neurological manifestations of niemann-pick disease type-c (npc) for a duration of greater than 3 months; Treatment of neurological manifestations of niemann-pick disease type-c (npc) for...
Dosage: FOR SUSPENSION
More Information on Dosage
AQNEURSA family patents
3. Attruby 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. | ||||
| US9642838 | BRIDGEBIO | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(5 years from now) | |
| US10513497 | BRIDGEBIO | Process for preparing AG-10, its intermediates, and salts thereof |
Feb, 2038
(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). | ||||
| US9169214 | BRIDGEBIO | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(5 years from now) | |
| US8877795 | BRIDGEBIO | Identification of stabilizers of multimeric proteins |
May, 2031
(5 years from now) | |
| US9913826 | BRIDGEBIO | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(5 years from now) | |
| US10842777 | BRIDGEBIO | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(5 years from now) | |
| US10398681 | BRIDGEBIO | Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions |
May, 2031
(5 years from now) | |
| US11919865 | BRIDGEBIO | Processes for preparing AG-10, its intermediates, and salts thereof |
Feb, 2038
(11 years from now) | |
| US12070449 | BRIDGEBIO | Methods of treating TTR amyloidosis using AG10 |
Mar, 2039
(13 years from now) | |
| US11058668 | BRIDGEBIO | Methods of treating TTR amyloidosis using AG10 |
Mar, 2039
(13 years from now) | |
| US11260047 | BRIDGEBIO | Formulations of AG10 |
Aug, 2039
(13 years from now) | |
| US12005043 | BRIDGEBIO | Formulations of AG10 |
Aug, 2039
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 22, 2029 |
| Orphan Drug Exclusivity(ODE-506) | Nov 22, 2031 |
Drugs and Companies using ACORAMIDIS HYDROCHLORIDE ingredient
NCE-1 date: 22 November, 2028
Market Authorisation Date: 22 November, 2024
Treatment: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (attr-cm)
Dosage: TABLET
More Information on Dosage
ATTRUBY family patents
4. Cobenfy 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). | ||||
| US10238643 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US10369144 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US10369143 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US10265311 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US10695339 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US11890378 | BRISTOL MYERS | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | |
| US10933020 | BRISTOL MYERS | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | |
| US11452692 | BRISTOL MYERS | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | |
| US10925832 | BRISTOL MYERS | Compositions and methods for treatment of disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | |
| US11471413 | BRISTOL MYERS | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 26, 2029 |
Drugs and Companies using TROSPIUM CHLORIDE; XANOMELINE TARTRATE ingredient
NCE-1 date: 26 September, 2028
Market Authorisation Date: 26 September, 2024
Treatment: Treatment of schizophrenia in adults
Dosage: CAPSULE
More Information on Dosage
COBENFY family patents
5. Crenessity 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. | ||||
| US12128033 | NEUROCRINE | Synthetic methods for preparation of 4-(2-chloro-4-methoxy-5-methylphenyl)-n-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-n-prop-2-ynyl-1,3-thiazol-2-amine |
Jun, 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). | ||||
| US11730739 | NEUROCRINE | Treatment of congenital adrenal hyperplasia |
Jan, 2035
(8 years from now) | |
| US10905690 | NEUROCRINE | Treatment of congenital adrenal hyperplasia |
Jan, 2035
(8 years from now) | |
| US11311544 | NEUROCRINE | Treatment of congenital adrenal hyperplasia |
Jan, 2035
(8 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 13, 2029 |
| Orphan Drug Exclusivity(ODE-503) | Dec 13, 2031 |
Drugs and Companies using CRINECERFONT ingredient
NCE-1 date: 13 December, 2028
Market Authorisation Date: 13 December, 2024
Treatment: Adjunctive treatment of classic congenital adrenal hyperplasia (cah)
Dosage: CAPSULE; SOLUTION
More Information on Dosage
CRENESSITY family patents
6. Duvyzat 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. | ||||
| US7329689 | ITALFARMACO | Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester |
Jan, 2027
(10 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9867799 | ITALFARMACO | Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy |
Feb, 2032
(5 years from now) | |
| US9421184 | ITALFARMACO | Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy |
Feb, 2032
(5 years from now) | |
| US10688047 | ITALFARMACO | Physically and chemically stable oral suspensions of givinostat |
Oct, 2036
(10 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 21, 2029 |
| Orphan Drug Exclusivity(ODE-473) | Mar 21, 2031 |
Drugs and Companies using GIVINOSTAT HYDROCHLORIDE ingredient
NCE-1 date: 21 March, 2028
Market Authorisation Date: 21 March, 2024
Treatment: A method for the treatment of duchenne muscular dystrophy (dmd) using givinostat
Dosage: SUSPENSION
More Information on Dosage
DUVYZAT family patents
7. Ensacove 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. | ||||
| US8551995 | XCOVERY | Kinase inhibitor compounds |
Feb, 2029
(2 years from now) | |
| US9296724 | XCOVERY | Substituted pyridazinecarboxamides as kinase inhibitors |
Jun, 2029
(3 years from now) | |
| US9126947 | XCOVERY | Substituted pyridazine carboxamide compounds |
Nov, 2031
(5 years from now) | |
| US10899744 | XCOVERY | Crystalline form of compound suppressing protein kinase activity, and application thereof |
Jun, 2037
(11 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2029 |
Drugs and Companies using ENSARTINIB HYDROCHLORIDE ingredient
NCE-1 date: 18 December, 2028
Market Authorisation Date: 18 December, 2024
Treatment: Treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc) who have not previously received an alk-inhibitor
Dosage: CAPSULE
More Information on Dosage
ENSACOVE family patents
8. Exblifep 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. | ||||
| US7687488 | ORCHID | 2-substituted methyl penam derivatives |
Dec, 2027
(1 year, 9 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11124526 | ORCHID | Crystalline beta-lactamase inhibitor |
Nov, 2034
(8 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 22, 2029 |
| Generating Antibiotic Incentives Now(GAIN) | Feb 22, 2034 |
Drugs and Companies using CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM ingredient
NCE-1 date: 23 February, 2028
Market Authorisation Date: 22 February, 2024
Treatment: Use of specified polymorphs of exblifep (cefepime and enmetazobactam) for treating complicated urinary tract infections (cuti) including pyelonephritis caused by designated susceptible microorganisms;...
Dosage: POWDER
More Information on Dosage
EXBLIFEP family patents
9. Flyrcado 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. | ||||
| US9161997 | GE HEALTHCARE | Contrast agents for myocardial perfusion imaging |
Feb, 2026
(24 days ago) | |
| US7344702 | GE HEALTHCARE | Contrast agents for myocardial perfusion imaging |
May, 2026
(2 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US8226929 | GE HEALTHCARE | Contrast agents for myocardial perfusion imaging |
Jun, 2028
(2 years from now) | |
| US9603951 | GE HEALTHCARE | Methods and apparatus for synthesizing imaging agents, and intermediates thereof |
May, 2031
(5 years from now) | |
| US8936777 | GE HEALTHCARE | Methods and apparatus for synthesizing imaging agents, and intermediates thereof |
Jun, 2031
(5 years from now) | |
| US9687571 | GE HEALTHCARE | Stabilization of radiopharmaceutical compositions using ascorbic acid |
Nov, 2032
(6 years from now) | |
| US12527884 | GE HEALTHCARE | NA |
May, 2042
(16 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 27, 2029 |
Drugs and Companies using FLURPIRIDAZ F-18 ingredient
NCE-1 date: 27 September, 2028
Market Authorisation Date: 27 September, 2024
Treatment: Method of positron emission tomography (pet) for cardiac imaging; Method of positron emission tomography (pet) for cardiac diseases
Dosage: SOLUTION
More Information on Dosage
FLYRCADO family patents
10. Iqirvo 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. | ||||
| US7943661 | IPSEN | Substituted 1,3-diphenylprop-2-en-1-one derivatives and preparation and uses thereof |
Sep, 2024
(1 year, 5 months ago) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US7632870 | IPSEN | Composition based on substituted 1,3-diphenylprop-2-en-1-one derivatives, preparation and uses thereof |
Sep, 2024
(1 year, 5 months ago) | |
| US11331292 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US12295927 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US12295928 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US12310935 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US11185519 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US11850223 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US12233038 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US11857523 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 10, 2029 |
| Orphan Drug Exclusivity(ODE-486) | Jun 10, 2031 |
Drugs and Companies using ELAFIBRANOR ingredient
NCE-1 date: 10 June, 2028
Market Authorisation Date: 10 June, 2024
Treatment: Treatment of primary biliary cholangitis (pbc); Treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults who have had an inadequate response to udca, or...
Dosage: TABLET
More Information on Dosage
IQIRVO family patents