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) | |
| US10239867 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 19 days from now) | |
| US11639347 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 19 days from now) | |
| US8623905 | VERTEX | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 1 month from now) | |
| US7645789 | VERTEX | Indole derivatives as CFTR modulators |
May, 2027
(1 year, 1 month from now) | |
| US7495103 | VERTEX | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 1 month from now) | |
| US7776905 | VERTEX | Modulators of ATP-binding cassette transporters |
Jun, 2027
(1 year, 2 months from now) | |
| USRE50453 | VERTEX | NA |
Jul, 2031
(5 years from now) | |
| US9512079 | VERTEX | Deuterated CFTR potentiators |
May, 2032
(6 years from now) | |
| US8865902 | VERTEX | Deuterated CFTR potentiators |
May, 2032
(6 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) | |
| 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
(3 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) | |
| 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) | |
| US9974781 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 19 days from now) | |
| US10022352 | VERTEX | Modulators of ATP-binding cassette transporters |
Apr, 2027
(1 year, 19 days from now) | |
| US8598181 | VERTEX | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 1 month from now) | |
| US8324242 | VERTEX | Modulators of ATP-binding cassette transporters |
Aug, 2027
(1 year, 4 months from now) | |
| US8415387 | VERTEX | Modulators of ATP-binding cassette transporters |
Nov, 2027
(1 year, 7 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) | |
| 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) | |
| 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) | |
| 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) | |
| 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) | |
| 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). | ||||
| 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) | |
| US8877795 | BRIDGEBIO | Identification of stabilizers of multimeric proteins |
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) | |
| 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) | |
| 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) | |
| US11919865 | BRIDGEBIO | Processes for preparing AG-10, its intermediates, and salts thereof |
Feb, 2038
(11 years from now) | |
| US11058668 | BRIDGEBIO | Methods of treating TTR amyloidosis using AG10 |
Mar, 2039
(13 years from now) | |
| US12070449 | BRIDGEBIO | Methods of treating TTR amyloidosis using AG10 |
Mar, 2039
(13 years from now) | |
| US12539290 | BRIDGEBIO | NA |
Aug, 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). | ||||
| 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) | |
| US10369144 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US10238643 | BRISTOL MYERS | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | |
| US10925832 | BRISTOL MYERS | Compositions and methods for treatment of 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) | |
| US11471413 | BRISTOL MYERS | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | |
| US11890378 | 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) | |
| US11311544 | 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) | |
| 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: SOLUTION; CAPSULE
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
(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). | ||||
| 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) | |
| 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) | |
| 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, 8 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
(a month 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, 6 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, 6 months ago) | |
| US11857523 | 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) | |
| US11185519 | 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) | |
| US12233038 | IPSEN | Methods of treatment of cholestatic diseases |
Mar, 2037
(11 years from now) | |
| US11331292 | 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) | |
| US12310935 | 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) in combination with ursodeoxycholic acid (udca) in adults who have had an inadequate response to udca, or as monotherapy in patients unable to tolerate u...
Dosage: TABLET
More Information on Dosage
IQIRVO family patents