Pharsight

1. Cerezyme patents 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).
US5549892	GENZYME	Enhanced in vivo uptake of glucocerebrosidase	Aug, 2013 (10 years ago)

Drugs and Companies using IMIGLUCERASE ingredient

Market Authorisation Date: 23 May, 1994

Treatment: Method of treating a human subject having gaucher's disease

Dosage: INJECTABLE;INJECTION

Strength	Dosage	Availability
400 UNITS/VIAL	INJECTABLE;INJECTION	Prescription
200 UNITS/VIAL	INJECTABLE;INJECTION	Prescription

CEREZYME family patents

2. Clolar patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5661136	GENZYME	2-halo-2'-fluoro ARA adenosines as antinoplastic agents	Jan, 2018 (6 years ago)
US5661136 (Pediatric)	GENZYME	2-halo-2'-fluoro ARA adenosines as antinoplastic agents	Jul, 2018 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Dec 28, 2011
Pediatric Exclusivity(PED)	Jun 28, 2012

Drugs and Companies using CLOFARABINE ingredient

Market Authorisation Date: 28 December, 2004

Treatment: Clolar is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1 mg/mL, 20 mL vial	23 Feb, 2012	1	09 May, 2017	14 Jan, 2018	Eligible

Strength	Dosage	Availability
20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription

CLOLAR family patents

3. Mozobil patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10184509A	2020-05-07	Accord Healthcare Ltd	Granted and Under Opposition
EP10184509A	2020-05-07	Sandoz AG	Granted and Under Opposition
EP10184509A	2020-05-07	Zentiva, k.s.	Granted and Under Opposition
EP10184509A	2020-05-07	STADA Arzneimittel AG	Granted and Under Opposition
EP10184509A	2020-05-07	Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH	Granted and Under Opposition
EP10184509A	2020-05-06	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition
EP10184509A	2020-05-04	Generics [UK] Limited (trading as Mylan)	Granted and Under Opposition
EP02750370A	2012-09-28	Actavis group PTC ehf	Revoked
EP02750370A	2012-09-27	Taylor Wessing LLP	Revoked
EP02750370A	2012-09-26	Generics [UK] Limited	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE42152	GENZYME	Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity	Dec, 2018 (5 years ago)
US6987102	GENZYME	Methods to mobilize progenitor/stem cells	Jul, 2023 (8 months ago)
US7897590	GENZYME	Methods to mobilize progenitor/stem cells	Jul, 2023 (8 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Dec 15, 2015
New Chemical Entity Exclusivity(NCE)	Dec 15, 2013

Drugs and Companies using PLERIXAFOR ingredient

NCE-1 date: 15 December, 2012

Market Authorisation Date: 15 December, 2008

Treatment: Use in combination with granulocyte-colony stimulating factor (g-csf) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with n...

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
24 mg/1.2 mL vials (20 mg/mL)	17 Dec, 2012	3		23 Jul, 2023	Extinguished

Strength	Dosage	Availability
24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription

MOZOBIL family patents

4. Renagel patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7014846	GENZYME	Phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US6509013	GENZYME	Method of making phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US5496545	GENZYME	Phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US7459151	GENZYME	Phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US5667775	GENZYME	Phosphate-binding polymers for oral administration	Sep, 2014 (9 years ago)
US6733780	GENZYME	Direct compression polymer tablet core	Oct, 2020 (3 years ago)

Drugs and Companies using SEVELAMER HYDROCHLORIDE ingredient

Market Authorisation Date: 12 July, 2000

Treatment: Phosphate binding

Dosage: TABLET;ORAL; CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
400 mg and 800 mg	22 May, 2008	1		18 Oct, 2020	Extinguished

Strength	Dosage	Availability
800MG	TABLET;ORAL	Prescription
400MG	TABLET;ORAL	Prescription
403MG	CAPSULE;ORAL	Discontinued

RENAGEL family patents

5. Renvela patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06824928A	2016-07-20	Alpex Pharma S.A.	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6509013	GENZYME	Method of making phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US5496545	GENZYME	Phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US6858203	GENZYME	Method of making phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US7014846	GENZYME	Phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US7459151	GENZYME	Phosphate-binding polymers for oral administration	Aug, 2013 (10 years ago)
US5667775	GENZYME	Phosphate-binding polymers for oral administration	Sep, 2014 (9 years ago)
US9095509	GENZYME	Sachet formulation for amine polymers	Dec, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Nov 25, 2019
New Dosage Form(NDF)	Aug 12, 2012

Drugs and Companies using SEVELAMER CARBONATE ingredient

Market Authorisation Date: 18 February, 2009

Treatment: Phosphate binding

Dosage: FOR SUSPENSION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.8 g/packet and 2.4 g/packet	30 Dec, 2009	1		16 Sep, 2014	Extinguished
800 mg	04 Dec, 2008	1	23 Oct, 2017	16 Sep, 2014	Extinguished

Strength	Dosage	Availability
800MG/PACKET	FOR SUSPENSION;ORAL	Prescription
2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription

RENVELA family patents

6. Thyrogen patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5840566	GENZYME	Isolation of a gene encoding human thyrotropin beta subunit	Nov, 2015 (8 years ago)
US6365127	GENZYME	Isolation of a gene encoding human thyrotropin beta subunit	Nov, 2015 (8 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Dec 14, 2014

Drugs and Companies using THYROTROPIN ALFA ingredient

Market Authorisation Date: 30 November, 1998

Treatment: Use as adjunct diagnostic for serum thyroglobulin (tg) testing