Drugs facing NCE-1 in 2027
Drugs becoming eligible for first Paragraph IV ANDA filing in 2027
1. Agamree 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. | ||||
| US12201639 | CATALYST | Aqueous oral pharmaceutical suspension compositions |
Mar, 2040
(14 years from now) | |
| US11382922 | CATALYST | Aqueous oral pharmaceutical suspension compositions |
Jul, 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). | ||||
| US8334279 | CATALYST | Non-hormonal steroid modulators of NF-κB for treatment of disease |
May, 2029
(3 years from now) | |
| US11833159 | CATALYST | Non-hormonal steroid modulators of NF-kB for treatment of disease |
May, 2029
(3 years from now) | |
| US10857161 | CATALYST | Non-hormonal steroid modulators of NF-kB for treatment of disease |
May, 2029
(3 years from now) | |
| US11690853 | CATALYST | Non-hormonal steroid modulators of NF-κβ for treatment of disease |
Mar, 2033
(7 years from now) | |
| US11471471 | CATALYST | Aqueous oral pharmaceutical suspension compositions |
Mar, 2040
(14 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 26, 2028 |
| Orphan Drug Exclusivity(ODE-450) | Oct 26, 2030 |
Drugs and Companies using VAMOROLONE ingredient
NCE-1 date: 27 October, 2027
Market Authorisation Date: 26 October, 2023
Treatment: Treatment of duchenne muscular dystrophy
Dosage: SUSPENSION
More Information on Dosage
AGAMREE family patents
2. Aphexda 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). | ||||
| US12257285 | AYRMID | Composition of BL-8040 |
Dec, 2041
(15 years from now) | |
| US12268725 | AYRMID | Composition of BL-8040 |
Dec, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 08, 2028 |
| Orphan Drug Exclusivity(ODE-442) | Sep 08, 2030 |
Drugs and Companies using MOTIXAFORTIDE ACETATE ingredient
NCE-1 date: 09 September, 2027
Market Authorisation Date: 08 September, 2023
Treatment: NA
Dosage: POWDER
More Information on Dosage
APHEXDA family patents
3. Augtyro 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. | ||||
| USRE50634 | BRISTOL | NA |
Jan, 2035
(8 years from now) | |
| US9714258 | BRISTOL | Diaryl macrocycles as modulators of protein kinases |
Jan, 2035
(8 years from now) | |
| US10294242 | BRISTOL | Diaryl macrocycle polymorph |
Jul, 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). | ||||
| US12187739 | BRISTOL | Diaryl macrocycle polymorph |
Jul, 2036
(10 years from now) | |
| US12310968 | BRISTOL | Chiral diaryl macrocycles and uses thereof |
Jul, 2036
(10 years from now) | |
| US11452725 | BRISTOL | Chiral diaryl macrocycles and uses thereof |
Jul, 2036
(10 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 15, 2028 |
| ODE*(ODE*) | Nov 15, 2030 |
| Orphan Drug Exclusivity(ODE-455) | Nov 15, 2030 |
| Orphan Drug Exclusivity(ODE-483) | Jun 13, 2031 |
| Orphan Drug Exclusivity(ODE-488) | Jun 13, 2031 |
Drugs and Companies using REPOTRECTINIB ingredient
NCE-1 date: 16 November, 2027
Market Authorisation Date: 15 November, 2023
Treatment: Treatment of adult patients with locally advanced or metastatic ros1-positive non-small cell lung cancer (nsclc); Treatment of adult and pediatric patients >12 years with solid tumors and ntrk gene fu...
Dosage: CAPSULE
More Information on Dosage
AUGTYRO family patents
4. Brenzavvy 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. | ||||
| US8802637 | THERACOSBIO | Benzylbenzene derivatives and methods of use |
Aug, 2028
(2 years from now) | |
| US7838499 | THERACOSBIO | Benzylbenzene derivatives and methods of use |
Jan, 2029
(2 years from now) | |
| US10981942 | THERACOSBIO | Crystalline form of benzylbenzene SGLT2 inhibitor |
Jun, 2031
(5 years from now) | |
| US8987323 | THERACOSBIO | Crystalline form of benzylbenzene SGLT2 inhibitor |
May, 2032
(6 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). | ||||
| US8106021 | THERACOSBIO | Benzylbenzene derivatives and methods of use |
Aug, 2028
(2 years from now) | |
| US10533032 | THERACOSBIO | Crystalline form of benzylbenzene SGLT2 inhibitor |
Jul, 2031
(5 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 20, 2028 |
Drugs and Companies using BEXAGLIFLOZIN ingredient
NCE-1 date: 20 January, 2027
Market Authorisation Date: 20 January, 2023
Treatment: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Dosage: TABLET
More Information on Dosage
BRENZAVVY family patents
5. Daybue 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. | ||||
| US11370755 | ACADIA | Compositions of trofinetide |
Aug, 2040
(14 years from now) | |
| US12492167 | ACADIA | NA |
Jul, 2042
(16 years from now) | |
| US11827600 | ACADIA | Crystalline forms of trofinetide |
Jul, 2042
(16 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). | ||||
| US9212204 | ACADIA | Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid |
Jan, 2032
(5 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 10, 2028 |
| Orphan Drug Exclusivity(ODE-425) | Mar 10, 2030 |
Drugs and Companies using TROFINETIDE ingredient
NCE-1 date: 11 March, 2027
Market Authorisation Date: 10 March, 2023
Treatment: Treatment of rett syndrome or a symptom thereof
Dosage: SOLUTION
More Information on Dosage
DAYBUE family patents
6. Daybue Stix 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. | ||||
| US11370755 | ACADIA | Compositions of trofinetide |
Aug, 2040
(14 years from now) | |
| US11827600 | ACADIA | Crystalline forms of trofinetide |
Jul, 2042
(16 years from now) | |
| US12492167 | ACADIA | NA |
Jul, 2042
(16 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). | ||||
| US9212204 | ACADIA | Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid |
Jan, 2032
(5 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 10, 2028 |
| ODE*(ODE*) | Mar 10, 2030 |
Drugs and Companies using TROFINETIDE ingredient
NCE-1 date: 11 March, 2027
Market Authorisation Date: 11 December, 2025
Treatment: Treatment of rett syndrome or a symptom thereof
Dosage: FOR SOLUTION
More Information on Dosage
DAYBUE STIX family patents
7. Defencath 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. | ||||
| US8541393 | CORMEDIX | Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin |
Nov, 2024
(1 year, 3 months ago) | |
| US9339036 | CORMEDIX | Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin |
Nov, 2024
(1 year, 3 months ago) | |
| US7696182 | CORMEDIX | Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin |
May, 2026
(2 months from now) | |
| US11738120 | CORMEDIX | Synthesis of taurolidine, purity profiles and polymorphs |
Apr, 2042
(16 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 15, 2028 |
| Generating Antibiotic Incentives Now(GAIN) | Nov 15, 2033 |
Drugs and Companies using HEPARIN SODIUM; TAUROLIDINE ingredient
NCE-1 date: 16 November, 2027
Market Authorisation Date: 15 November, 2023
Treatment: A catheter lock solution to reduce catheter-related bloodstream infections in adult patients receiving hemodialysis through a central venous catheter
Dosage: SOLUTION
More Information on Dosage
DEFENCATH family patents
8. Exxua 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). | ||||
| US7538116 | FABRE KRAMER | Treatment of sexual disorders |
Sep, 2030
(4 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 22, 2028 |
Drugs and Companies using GEPIRONE HYDROCHLORIDE ingredient
NCE-1 date: 23 September, 2027
Market Authorisation Date: 22 September, 2023
Treatment: Treatment of subjects with major depression with sexual dysfunction caused by either major depression or prior treatments, or treatment of subjects with major depression without the risk of sexual dys...
Dosage: TABLET, EXTENDED RELEASE
More Information on Dosage
EXXUA family patents
9. Fabhalta 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. | ||||
| US9682968 | NOVARTIS | Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof |
Jul, 2034
(8 years from now) | |
| US11603363 | NOVARTIS | Crystalline form of LNP023 |
May, 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). | ||||
| US10093663 | NOVARTIS | Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof |
Jul, 2034
(8 years from now) | |
| US11723901 | NOVARTIS | Uses of piperidinyl-indole derivatives |
Aug, 2038
(12 years from now) | |
| US12285422 | NOVARTIS | Uses of piperidinyl-indole derivatives |
Aug, 2038
(12 years from now) | |
| US12384758 | NOVARTIS | Crystalline Form Of Lnp023 |
May, 2041
(15 years from now) | |
| US12453726 | NOVARTIS | Methods Of Using Factor B Inhibitors |
Jul, 2041
(15 years from now) | |
| US11951101 | NOVARTIS | Methods of using factor B inhibitors |
Jul, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-949) | Aug 07, 2027 |
| New Indication(I-963) | Mar 20, 2028 |
| New Chemical Entity Exclusivity(NCE) | Dec 05, 2028 |
| Orphan Drug Exclusivity(ODE-456) | Dec 05, 2030 |
Drugs and Companies using IPTACOPAN HYDROCHLORIDE ingredient
NCE-1 date: 06 December, 2027
Market Authorisation Date: 05 December, 2023
Treatment: Treatment of primary immunoglobulin a nephropathy (igan); Treatment of complement 3 glomerulopathy (c3g) by administration of 200 mg of iptacopan twice daily; Treatment of complement 3 glomerulopathy ...
Dosage: CAPSULE
More Information on Dosage
FABHALTA family patents
10. Filspari patent expiration
FILSPARI's oppositions filed in EPO
| 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). | ||||
| US9993461 | TRAVERE | Method for treating disorders associated with glomerular function |
Mar, 2030
(4 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 17, 2028 |
| Orphan Drug Exclusivity(ODE-389) | Feb 17, 2030 |
| Orphan Drug Exclusivity(ODE-493) | Sep 05, 2031 |
Drugs and Companies using SPARSENTAN ingredient
NCE-1 date: 17 February, 2027
Market Authorisation Date: 17 February, 2023
Treatment: Treatment of primary immunoglobulin a nephropathy (igan) in adults at risk for disease progression
Dosage: TABLET
More Information on Dosage
FILSPARI family patents