Metabolic Disorders Therapeutics
1. Cerdelga patent expiration
Treatment: Treatment of gaucher disease type 1; Long-term treatment of adults with gaucher disease type 1 who are cyp2d6 extensive or intermediate metabolizers with 84 mg twice per day of eliglustat (equivalent ...
CERDELGA's oppositions filed in EPO
CERDELGA 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. | ||||
| US6916802 | GENZYME | Amino ceramide-like compounds and therapeutic methods of use |
Apr, 2022
(3 years ago) | |
| US7196205 | GENZYME | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors |
Jun, 2026
(4 months from now) | |
| US11458119 | GENZYME | Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase |
Nov, 2030
(4 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). | ||||
| US7615573 | GENZYME | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors |
Apr, 2022
(3 years ago) | |
| US7253185 | GENZYME | Amino ceramide-like compounds and therapeutic methods of use |
Apr, 2022
(3 years ago) | |
| US10888547 | GENZYME | Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase |
Jan, 2031
(4 years from now) | |
| US10888544 | GENZYME | Methods for treating Gaucher disease |
Dec, 2038
(12 years from now) | |
| US12465586 | GENZYME | Inhibitors Of Glucosylceramide Synthase |
Jun, 2032
(6 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 19, 2019 |
| Orphan Drug Exclusivity(ODE) | Aug 19, 2021 |
| Orphan Drug Exclusivity(ODE-73) | Aug 19, 2021 |
Drugs and Companies using ELIGLUSTAT TARTRATE ingredient
NCE-1 date: 19 August, 2018
Market Authorisation Date: 19 August, 2014
Dosage: CAPSULE
How can I launch a generic of CERDELGA before it's drug patent expiration?
More Information on Dosage
CERDELGA family patents
2. Dojolvi patent expiration
Treatment: NA
| 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). | ||||
| US9186344 | ULTRAGENYX | Glycogen or polysaccharide storage disease treatment method |
Jul, 2025
(7 months ago) | |
| US8697748 | ULTRAGENYX | Glycogen or polysaccharide storage disease treatment method |
Apr, 2029
(3 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 30, 2025 |
| Orphan Drug Exclusivity(ODE-311) | Jun 30, 2027 |
Drugs and Companies using TRIHEPTANOIN ingredient
NCE-1 date: 30 June, 2024
Market Authorisation Date: 30 June, 2020
Dosage: LIQUID
How can I launch a generic of DOJOLVI before it's drug patent expiration?
More Information on Dosage
DOJOLVI family patents
3. Givlaari patent
expiration
Treatment: Treatment of acute hepatic porphyria
GIVLAARI's oppositions filed in EPO
GIVLAARI 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. | ||||
| US9708610 | ALNYLAM | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Jan, 2024
(2 years ago) | |
| US8546143 | ALNYLAM | Compositions and methods for inhibiting expression of a target gene |
Jan, 2022
(4 years ago) | |
| US10131907 | ALNYLAM | Glycoconjugates of RNA interference agents |
Aug, 2028
(2 years from now) | |
| US8106022 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(3 years from now) | |
| US10119143 | ALNYLAM | Compositions and methods for inhibiting expression of the ALAS1 gene |
Oct, 2034
(8 years from now) | |
| US8828956 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US11028392 | ALNYLAM | Compositions and methods for inhibiting expression of the ALAS1 gene |
Oct, 2034
(8 years from now) | |
| US10125364 | ALNYLAM | Compositions and methods for inhibiting expression of the ALAS1 gene |
Mar, 2033
(7 years from now) | |
| US11530408 | ALNYLAM | Therapeutic compositions |
May, 2024
(1 year, 9 months ago) | |
| US9708615 | ALNYLAM | Therapeutic compositions |
Mar, 2024
(1 year, 11 months ago) | |
| US10273477 | ALNYLAM | Therapeutic compositions |
Mar, 2024
(1 year, 11 months ago) | |
| US9133461 | ALNYLAM | Compositions and methods for inhibiting expression of the ALAS1 gene |
Nov, 2033
(7 years from now) | |
| US9150605 | ALNYLAM | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Aug, 2025
(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). | ||||
| US9631193 | ALNYLAM | Compositions and methods for inhibiting expression of the ALAS1 gene |
Mar, 2033
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 20, 2024 |
| Orphan Drug Exclusivity(ODE-273) | Nov 20, 2026 |
Drugs and Companies using GIVOSIRAN SODIUM ingredient
NCE-1 date: 21 November, 2023
Market Authorisation Date: 20 November, 2019
Dosage: SOLUTION
More Information on Dosage
GIVLAARI family patents
4. Kuvan patent expiration
Treatment: Kuvan is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia; To reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa); Method of use f...
KUVAN'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). | ||||
| USRE43797 | BIOMARIN | Methods of administering tetrahydrobiopterin |
Nov, 2024
(1 year, 3 months ago) | |
|
US7947681 (Pediatric) | BIOMARIN | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
May, 2025
(9 months ago) | |
| US7947681 | BIOMARIN | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
Nov, 2024
(1 year, 3 months ago) | |
| US7566714 | BIOMARIN | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(1 year, 3 months ago) | |
|
US9433624 (Pediatric) | BIOMARIN | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(9 months ago) | |
| US7612073 | BIOMARIN | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
Nov, 2024
(1 year, 3 months ago) | |
| US9433624 | BIOMARIN | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(1 year, 3 months ago) | |
| US8067416 | BIOMARIN | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(1 year, 3 months ago) | |
| US8003126 | BIOMARIN | Stable tablet formulation |
Nov, 2025
(3 months ago) | |
| US7566462 | BIOMARIN | Stable tablet formulation |
Nov, 2025
(3 months ago) | |
| US7727987 | BIOMARIN | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
Nov, 2024
(1 year, 3 months ago) | |
| US8318745 | BIOMARIN | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
Nov, 2024
(1 year, 3 months ago) | |
| US9216178 | BIOMARIN | Dry blend formulation of tetrahydrobiopterin |
Nov, 2032
(6 years from now) | |
|
US7566462 (Pediatric) | BIOMARIN | Stable tablet formulation |
May, 2026
(2 months from now) | |
|
US7566714 (Pediatric) | BIOMARIN | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(9 months ago) | |
|
US7612073 (Pediatric) | BIOMARIN | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
May, 2025
(9 months ago) | |
|
US7727987 (Pediatric) | BIOMARIN | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
May, 2025
(9 months ago) | |
|
US8003126 (Pediatric) | BIOMARIN | Stable tablet formulation |
May, 2026
(2 months from now) | |
|
US8067416 (Pediatric) | BIOMARIN | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(9 months ago) | |
|
US8318745 (Pediatric) | BIOMARIN | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
May, 2025
(9 months ago) | |
|
USRE43797 (Pediatric) | BIOMARIN | Methods of administering tetrahydrobiopterin |
May, 2025
(9 months ago) | |
|
US9216178 (Pediatric) | BIOMARIN | Dry blend formulation of tetrahydrobiopterin |
May, 2033
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 13, 2012 |
| Orphan Drug Exclusivity(ODE) | Dec 13, 2014 |
| New Patient Population(NPP) | Apr 23, 2017 |
| Pediatric Exclusivity(PED) | Oct 23, 2017 |
Drugs and Companies using SAPROPTERIN DIHYDROCHLORIDE ingredient
NCE-1 date: 23 October, 2016
Market Authorisation Date: 13 December, 2007
Dosage: TABLET; POWDER
How can I launch a generic of KUVAN before it's drug patent expiration?
More Information on Dosage
KUVAN family patents
5. Nulibry patent expiration
Treatment: Method of treating molybdenum cofactor deficiency type a
| 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). | ||||
| US7504095 | SENTYNL | Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency |
Apr, 2029
(3 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-286) | Oct 27, 2025 |
| New Chemical Entity Exclusivity(NCE) | Feb 26, 2026 |
| Orphan Drug Exclusivity(ODE-342) | Feb 26, 2028 |
Drugs and Companies using FOSDENOPTERIN HYDROBROMIDE ingredient
NCE-1 date: 26 February, 2025
Market Authorisation Date: 26 February, 2021
Dosage: POWDER
More Information on Dosage
NULIBRY family patents
6. Orfadin patent expiration
Treatment: Treatment of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine
| 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). | ||||
| US5550165 | SWEDISH ORPHAN | Pharmaceutical compositions for the treatment of hereditary tyosinemia type I |
Aug, 2013
(12 years ago) | |
| US9301932 | SWEDISH ORPHAN | Liquid pharmaceutical composition comprising nitisinone |
Feb, 2033
(7 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-169) | Sep 01, 2020 |
Drugs and Companies using NITISINONE ingredient
Market Authorisation Date: 18 January, 2002
Dosage: CAPSULE; SUSPENSION
More Information on Dosage
ORFADIN family patents
7. Oxlumo patent expiration
Treatment: Treatment of primary hyperoxaluria type 1 (ph1)
| 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. | ||||
| US11401517 | ALNYLAM | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US11060093 | ALNYLAM | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US10487330 | ALNYLAM | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US11261447 | ALNYLAM | Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression |
Nov, 2038
(12 years from now) | |
| US9828606 | ALNYLAM | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US10478500 | ALNYLAM | Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression |
Oct, 2035
(9 years from now) | |
| US8106022 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(3 years from now) | |
| US8828956 | ALNYLAM | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US10131907 | ALNYLAM | Glycoconjugates of RNA interference agents |
Aug, 2028
(2 years from now) | |
| US10612024 | ALNYLAM | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US10612027 | ALNYLAM | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US10465195 | ALNYLAM | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US11446380 | ALNYLAM | Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression |
Oct, 2035
(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). | ||||
| US10435692 | ALNYLAM | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-901) | Oct 06, 2025 |
| New Chemical Entity Exclusivity(NCE) | Nov 23, 2025 |
| Orphan Drug Exclusivity(ODE-339) | Nov 23, 2027 |
| Orphan Drug Exclusivity(ODE-415) | Oct 06, 2029 |
Drugs and Companies using LUMASIRAN SODIUM ingredient
NCE-1 date: 23 November, 2024
Market Authorisation Date: 23 November, 2020
Dosage: SOLUTION
More Information on Dosage
OXLUMO family patents
8. Sephience patent expiration
Treatment: Treatment of hyperphenylalaninemia (hpa) in adult and pediatric patients with sepiapterin-responsive phenylketonuria (pku) by administering sepiapterin; Method of treating hyperphenylalaninemia (hpa) ...
| 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. | ||||
| US11072614 | PTC | Polymorphs Of Sepiapterin And Salts Thereof |
Apr, 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). | ||||
| US11752154 | PTC | Pharmaceutical Compositions Comprising Sepiapterin And Uses Thereof |
Sep, 2038
(12 years from now) | |
| US12213982 | PTC | Pharmaceutical Compositions Comprising Sepiapterin And Uses Thereof |
Sep, 2038
(12 years from now) | |
| US12257252 | PTC | Compositions And Methods For Increasing Tetrahydrobiopterin Plasma Exposure |
Mar, 2042
(16 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 28, 2030 |
Drugs and Companies using SEPIAPTERIN ingredient
NCE-1 date: 28 July, 2029
Market Authorisation Date: 28 July, 2025
Dosage: POWDER
More Information on Dosage
SEPHIENCE family patents
9. Xuriden patent expiration
Treatment: NA
| 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). | ||||
| US6258795 | BTG | Acylated uridine and cytidine and uses thereof |
Jul, 2023
(2 years ago) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 04, 2020 |
| Orphan Drug Exclusivity(ODE) | Sep 04, 2022 |
| Orphan Drug Exclusivity(ODE-98) | Sep 04, 2022 |
Drugs and Companies using URIDINE TRIACETATE ingredient
NCE-1 date: 05 September, 2019
Market Authorisation Date: 04 September, 2015
Dosage: GRANULE
More Information on Dosage
XURIDEN family patents