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) | |
| 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) | |
| US8828956 | 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) | |
| US11401517 | ALNYLAM | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US10612024 | 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) | |
| US10208307 | 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) | |
| 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) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 17, 2027 |
| New Product(NP) | Dec 23, 2028 |
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) | |
| US10927258 | PROVEPHARM | Process for the preparation of Indigotindisulfonate sodium (indigo carmine) |
Dec, 2037
(11 years from now) | |
| US11499050 | 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) | |
| US12064487 | 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: Method of magnetic resonance imaging to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax,...
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 |
| New Patient Population(NPP) | Dec 19, 2028 |
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 |
| New Patient Population(NPP) | Dec 19, 2028 |
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