Drugs facing NCE-1 in 2026
Drugs becoming eligible for first Paragraph IV ANDA filing in 2026
1. Amvuttra patent expiration
AMVUTTRA'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. | ||||
| US10131907 | ALNYLAM | Glycoconjugates of RNA interference agents |
Aug, 2028
(2 years from now) | |
| US8828956 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US9370581 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US10806791 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US8106022 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(3 years from now) | |
| US10570391 | ALNYLAM | RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases |
Nov, 2032
(6 years from now) | |
| US9399775 | ALNYLAM | RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases |
Nov, 2032
(6 years from now) | |
| US10612024 | ALNYLAM | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US11401517 | ALNYLAM | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US10683501 | ALNYLAM | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(10 years from now) | |
| US11286486 | ALNYLAM | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(10 years from now) | |
| US12049628 | ALNYLAM | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(10 years from now) | |
| US10208307 | ALNYLAM | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases |
Jul, 2036
(10 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 13, 2027 |
| New Indication(I-964) | Mar 20, 2028 |
| Orphan Drug Exclusivity(ODE-212) | Jun 13, 2029 |
Drugs and Companies using VUTRISIRAN SODIUM ingredient
NCE-1 date: 13 June, 2026
Market Authorisation Date: 13 June, 2022
Treatment: Amvuttra is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Dosage: SOLUTION
More Information on Dosage
AMVUTTRA family patents
2. Aqvesme 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. | ||||
| USRE49582 | AGIOS | Therapeutic compounds and compositions |
Feb, 2031
(4 years from now) | |
| US11254652 | AGIOS | Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide |
Nov, 2038
(12 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). | ||||
| US9682080 | AGIOS | Pyruvate kinase activators for use in therapy |
May, 2032
(6 years from now) | |
| US10632114 | AGIOS | Pyruvate kinase activators for use in therapy |
May, 2032
(6 years from now) | |
| US9193701 | AGIOS | Pyruvate kinase activators for use in therapy |
Oct, 2032
(6 years from now) | |
| US11878049 | AGIOS | Mitapivat therapy and modulators of cytochrome P450 |
Jul, 2041
(15 years from now) | |
Drugs and Companies using MITAPIVAT SULFATE ingredient
NCE-1 date: 17 February, 2026
Market Authorisation Date: 23 December, 2025
Treatment: Method of using a pyruvate kinase activator for the treatment of anemia in adults with alpha or beta thalassemia; Method of using a pyruvate kinase activator for treating anemia in adults with alpha o...
Dosage: TABLET
More Information on Dosage
AQVESME family patents
3. Bludigo 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. | ||||
| US11845867 | PROVEPHARM | Process for the preparation of indigotindisulfonate sodium (indigo carmine) |
Nov, 2036
(10 years from now) | |
| US11499050 | PROVEPHARM | Process for the preparation of indigotindisulfonate sodium (indigo carmine) |
Dec, 2037
(11 years from now) | |
| US10927258 | PROVEPHARM | Process for the preparation of Indigotindisulfonate sodium (indigo carmine) |
Dec, 2037
(11 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 08, 2027 |
Drugs and Companies using INDIGOTINDISULFONATE SODIUM ingredient
NCE-1 date: 08 July, 2026
Market Authorisation Date: 08 July, 2022
Treatment: NA
Dosage: SOLUTION
More Information on Dosage
BLUDIGO family patents
4. Camzyos 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. | ||||
| US9181200 | BRISTOL | Pyrimidinedione compounds |
Jun, 2034
(8 years from now) | |
| USRE50050 | BRISTOL | Pyrimidinedione compounds |
Apr, 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). | ||||
| US9585883 | BRISTOL | Pyrimidinedione compounds |
Jun, 2034
(8 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-297) | Jun 15, 2026 |
| New Chemical Entity Exclusivity(NCE) | Apr 28, 2027 |
| Orphan Drug Exclusivity(ODE-398) | Apr 28, 2029 |
Drugs and Companies using MAVACAMTEN ingredient
NCE-1 date: 28 April, 2026
Market Authorisation Date: 28 April, 2022
Treatment: Treatment of adults with symptomatic new york heart association (nyha) class ii-iii obstructive hypertrophic cardiomyopathy (hcm) to improve functional capacity and symptoms
Dosage: CAPSULE
More Information on Dosage
CAMZYOS family patents
5. Cibinqo 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. | ||||
| US9545405 | PFIZER | Pyrrolo[2,3-D]pyrimidine derivatives |
Feb, 2034
(7 years from now) | |
| US9035074 | PFIZER | Pyrrolo[2,3-D]pyrimidine derivatives |
Jan, 2036
(9 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). | ||||
| US9549929 | PFIZER | Pyrrolo[2,3-D]pyrimidine derivatives |
Feb, 2034
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Feb 09, 2026 |
| New Chemical Entity Exclusivity(NCE) | Jan 14, 2027 |
Drugs and Companies using ABROCITINIB ingredient
NCE-1 date: 14 January, 2026
Market Authorisation Date: 14 January, 2022
Treatment: Treatment of adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products or when use of those therapies is inadvisable
Dosage: TABLET
More Information on Dosage
CIBINQO family patents
6. Elucirem patent expiration
ELUCIREM'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. | ||||
| US8114863 | GUERBET | Compounds comprising short aminoalcohol chains and metal complexes for medical imaging |
Sep, 2028
(2 years from now) | |
| US10973934 | GUERBET | Gadolinium bearing PCTA-based contrast agents |
Aug, 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). | ||||
| US11590246 | GUERBET | Complex of gadolinium and a chelating ligand derived from a diastereoisomerically enriched PCTA and preparation and purification process |
Jan, 2040
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 21, 2027 |
Drugs and Companies using GADOPICLENOL ingredient
NCE-1 date: 21 September, 2026
Market Authorisation Date: 21 September, 2022
Treatment: NA
Dosage: SOLUTION
More Information on Dosage
ELUCIREM family patents
7. Krazati 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. | ||||
| US10689377 | BRISTOL | KRas G12C inhibitors |
May, 2037
(11 years from now) | |
| US12281113 | BRISTOL | Crystalline forms of a KRas G12C inhibitor |
Sep, 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). | ||||
| US12336995 | BRISTOL | Combination Therapies |
Feb, 2041
(14 years from now) | |
| US12383503 | BRISTOL | Adagrasib Solid Pharmaceutical Compositions |
Aug, 2043
(17 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2027 |
| Orphan Drug Exclusivity(ODE-352) | Dec 12, 2029 |
Drugs and Companies using ADAGRASIB ingredient
NCE-1 date: 12 December, 2026
Market Authorisation Date: 12 December, 2022
Treatment: Treatment, in combination with cetuximab, of adult patients with kras g12c-muted locally advanced or metastatic colorectal cancer, per fda approved test, where prior treatment with fluoropyrimidine-, ...
Dosage: TABLET
More Information on Dosage
KRAZATI family patents
8. Lytgobi 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. | ||||
| US9108973 | TAIHO | 3,5-disubstituted alkynylbenzene compound and salt thereof |
Feb, 2033
(6 years from now) | |
| US10434103 | TAIHO | Crystal of 3,5-disubstituted benzene alkynyl compound |
Mar, 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). | ||||
| US11833151 | TAIHO | Pharmaceutical composition including sodium alkyl sulfate |
Nov, 2039
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 30, 2027 |
| ODE*(ODE*) | Sep 30, 2029 |
| Orphan Drug Exclusivity(ODE-410) | Sep 30, 2029 |
Drugs and Companies using FUTIBATINIB ingredient
NCE-1 date: 30 September, 2026
Market Authorisation Date: 30 September, 2022
Treatment: Method of treating intrahepatic cholangiocarcinoma
Dosage: TABLET
More Information on Dosage
LYTGOBI family patents
9. Mounjaro patent expiration
MOUNJARO 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. | ||||
| US9474780 | ELI LILLY | GIP and GLP-1 co-agonist compounds |
Jan, 2036
(9 years from now) | |
| US11357820 | ELI LILLY | GIP/GLP1 agonist compositions |
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). | ||||
| US12453756 | ELI LILLY | Gip/Glp1 Agonist Compositions |
Jun, 2039
(13 years from now) | |
| US12453755 | ELI LILLY | Gip/Glp1 Agonist Compositions |
Jun, 2039
(13 years from now) | |
| US12343382 | ELI LILLY | Methods Of Using A Gip/Glp1 Co-Agonist For Therapy |
Jul, 2039
(13 years from now) | |
| US12295987 | ELI LILLY | Method of using a GIP/GLP1 co-agonist for diabetes |
Dec, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 13, 2027 |
Drugs and Companies using TIRZEPATIDE ingredient
NCE-1 date: 13 May, 2026
Market Authorisation Date: 28 July, 2023
Treatment: A method for improving glycemic control in patients with t2dm by administering a 5 mg/ml, 10 mg/ml, 15 mg/ml, 20 mg/ml, 25 mg/ml, or 30 mg/ml dose of tirzepatide, about 1.34 mg/ml of na2hpo4, and abou...
Dosage: SOLUTION
More Information on Dosage
MOUNJARO family patents
10. Mounjaro (autoinjector) patent expiration
MOUNJARO (AUTOINJECTOR) 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. | ||||
| US9474780 | ELI LILLY | GIP and GLP-1 co-agonist compounds |
Jan, 2036
(9 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). | ||||
| US8734394 | ELI LILLY | Automatic injection device with delay mechanism including dual functioning biasing member |
Feb, 2031
(4 years from now) | |
| US9402957 | ELI LILLY | Automatic injection device with delay mechanism including dual functioning biasing member |
Jun, 2031
(5 years from now) | |
| US12453756 | ELI LILLY | Gip/Glp1 Agonist Compositions |
Jun, 2039
(13 years from now) | |
| US11357820 | ELI LILLY | GIP/GLP1 agonist compositions |
Jun, 2039
(13 years from now) | |
| US12453755 | ELI LILLY | Gip/Glp1 Agonist Compositions |
Jun, 2039
(13 years from now) | |
| US12343382 | ELI LILLY | Methods Of Using A Gip/Glp1 Co-Agonist For Therapy |
Jul, 2039
(13 years from now) | |
| US12295987 | ELI LILLY | Method of using a GIP/GLP1 co-agonist for diabetes |
Dec, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 13, 2027 |
Drugs and Companies using TIRZEPATIDE ingredient
NCE-1 date: 13 May, 2026
Market Authorisation Date: 28 July, 2023
Treatment: A method for improving glycemic control in patients with t2dm by administering a composition comprising an effective dose of about 5-30 mg/ml of tirzepatide, about 1.34 mg/ml of na2hpo4, about 8.2 mg/...
Dosage: SOLUTION
More Information on Dosage
MOUNJARO (AUTOINJECTOR) family patents