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 CORP | Amino ceramide-like compounds and therapeutic methods of use |
Apr, 2022
(3 years ago) | |
| US7196205 | GENZYME CORP | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors |
Jun, 2026
(5 months from now) | |
| US11458119 | GENZYME CORP | 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 CORP | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors |
Apr, 2022
(3 years ago) | |
| US7253185 | GENZYME CORP | Amino ceramide-like compounds and therapeutic methods of use |
Apr, 2022
(3 years ago) | |
| US12465586 | GENZYME CORP | NA |
Jun, 2032
(6 years from now) | |
| US10888547 | GENZYME CORP | Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase |
Jan, 2031
(5 years from now) | |
| US10888544 | GENZYME CORP | Methods for treating Gaucher disease |
Dec, 2038
(12 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 PHARM INC | Glycogen or polysaccharide storage disease treatment method |
Jul, 2025
(6 months ago) | |
| US8697748 | ULTRAGENYX PHARM INC | 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
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
Can you believe GIVLAARI received compensation for the extended wait time during the regulatory approval process?
| 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 PHARMS INC | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Jan, 2024
(2 years ago) | |
| US8546143 | ALNYLAM PHARMS INC | Compositions and methods for inhibiting expression of a target gene |
Jan, 2022
(4 years ago) | |
| US10131907 | ALNYLAM PHARMS INC | Glycoconjugates of RNA interference agents |
Aug, 2028
(2 years from now) | |
| US8106022 | ALNYLAM PHARMS INC | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(3 years from now) | |
| US10119143 | ALNYLAM PHARMS INC | Compositions and methods for inhibiting expression of the ALAS1 gene |
Oct, 2034
(8 years from now) | |
| US8828956 | ALNYLAM PHARMS INC | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US10125364 | ALNYLAM PHARMS INC | Compositions and methods for inhibiting expression of the ALAS1 gene |
Mar, 2033
(7 years from now) | |
| US11028392 | ALNYLAM PHARMS INC | Compositions and methods for inhibiting expression of the ALAS1 gene |
Oct, 2034
(8 years from now) | |
| US11530408 | ALNYLAM PHARMS INC | Therapeutic compositions |
May, 2024
(1 year, 7 months ago) | |
| US9708615 | ALNYLAM PHARMS INC | Therapeutic compositions |
Mar, 2024
(1 year, 10 months ago) | |
| US10273477 | ALNYLAM PHARMS INC | Therapeutic compositions |
Mar, 2024
(1 year, 10 months ago) | |
| US9133461 | ALNYLAM PHARMS INC | Compositions and methods for inhibiting expression of the ALAS1 gene |
Nov, 2033
(7 years from now) | |
| US9150605 | ALNYLAM PHARMS INC | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Aug, 2025
(4 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 PHARMS INC | 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: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia; Kuvan is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia; T...
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). | ||||
| US8067416 | BIOMARIN PHARM | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(1 year, 1 month ago) | |
| USRE43797 | BIOMARIN PHARM | Methods of administering tetrahydrobiopterin |
Nov, 2024
(1 year, 1 month ago) | |
|
US7947681 (Pediatric) | BIOMARIN PHARM | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
May, 2025
(7 months ago) | |
| US7947681 | BIOMARIN PHARM | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
Nov, 2024
(1 year, 1 month ago) | |
| US7566714 | BIOMARIN PHARM | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(1 year, 1 month ago) | |
| US7612073 | BIOMARIN PHARM | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
Nov, 2024
(1 year, 1 month ago) | |
| US9433624 | BIOMARIN PHARM | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(1 year, 1 month ago) | |
| US8003126 | BIOMARIN PHARM | Stable tablet formulation |
Nov, 2025
(a month ago) | |
| US7566462 | BIOMARIN PHARM | Stable tablet formulation |
Nov, 2025
(a month ago) | |
| US7727987 | BIOMARIN PHARM | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
Nov, 2024
(1 year, 1 month ago) | |
| US9216178 | BIOMARIN PHARM | Dry blend formulation of tetrahydrobiopterin |
Nov, 2032
(6 years from now) | |
| US8318745 | BIOMARIN PHARM | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
Nov, 2024
(1 year, 1 month ago) | |
|
US7566462 (Pediatric) | BIOMARIN PHARM | Stable tablet formulation |
May, 2026
(4 months from now) | |
|
US7566714 (Pediatric) | BIOMARIN PHARM | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(7 months ago) | |
|
US7612073 (Pediatric) | BIOMARIN PHARM | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
May, 2025
(7 months ago) | |
|
US7727987 (Pediatric) | BIOMARIN PHARM | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
May, 2025
(7 months ago) | |
|
US8003126 (Pediatric) | BIOMARIN PHARM | Stable tablet formulation |
May, 2026
(4 months from now) | |
|
US8067416 (Pediatric) | BIOMARIN PHARM | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(7 months ago) | |
|
US8318745 (Pediatric) | BIOMARIN PHARM | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
May, 2025
(7 months ago) | |
|
USRE43797 (Pediatric) | BIOMARIN PHARM | Methods of administering tetrahydrobiopterin |
May, 2025
(7 months ago) | |
|
US9433624 (Pediatric) | BIOMARIN PHARM | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(7 months ago) | |
|
US9216178 (Pediatric) | BIOMARIN PHARM | 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
Market Authorisation Date: 19 December, 2013
Dosage: POWDER; TABLET
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 THERAPS INC | 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)
Can you believe OXLUMO received compensation for the extended wait time during the regulatory approval process?
| 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 PHARMS INC | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US11060093 | ALNYLAM PHARMS INC | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US10487330 | ALNYLAM PHARMS INC | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US10478500 | ALNYLAM PHARMS INC | Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression |
Oct, 2035
(9 years from now) | |
| US8106022 | ALNYLAM PHARMS INC | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(3 years from now) | |
| US8828956 | ALNYLAM PHARMS INC | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(2 years from now) | |
| US10131907 | ALNYLAM PHARMS INC | Glycoconjugates of RNA interference agents |
Aug, 2028
(2 years from now) | |
| US10612024 | ALNYLAM PHARMS INC | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US10612027 | ALNYLAM PHARMS INC | Modified double-stranded RNA agents |
Aug, 2035
(9 years from now) | |
| US10465195 | ALNYLAM PHARMS INC | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US11261447 | ALNYLAM PHARMS INC | Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression |
Nov, 2038
(12 years from now) | |
| US9828606 | ALNYLAM PHARMS INC | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(8 years from now) | |
| US11446380 | ALNYLAM PHARMS INC | 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 PHARMS INC | 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: Method of treating hyperphenylalaninemia (hpa) in adult and pediatric patients with sepiapterin-responsive phenylketonuria (pku) by administering sepiapterin with food; Treatment of hyperphenylalanine...
| 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 THERAP | NA |
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). | ||||
| US12257252 | PTC THERAP | NA |
Mar, 2042
(16 years from now) | |
| US12213982 | PTC THERAP | NA |
Sep, 2038
(12 years from now) | |
| US11752154 | PTC THERAP | NA |
Sep, 2038
(12 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 INTL | 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