Pharsight

Application	Filing Date	Opposition Party	Legal Status

EP10184575A	2015-09-30	Actavis Group PTC ehf	Revoked
EP10184575A	2015-09-29	Fresenius Kabi Deutschland GmbH	Revoked
EP04759349A	2015-09-24	Actavis Group PTC ehf	Patent maintained as amended
EP04759349A	2015-09-24	Fresenius Kabi Deutschland GmbH	Patent maintained as amended
EP10184684A	2015-09-24	Fresenius Kabi Deutschland GmbH	Revoked
EP10184684A	2015-09-24	Actavis Group PTC ehf	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).
US6559158	SALIX PHARMS	Use of methylnaltrexone and related compounds to treat chronic opioid use side affects	Nov, 2017 (6 years ago)
US8552025	SALIX PHARMS	Stable methylnaltrexone preparation	Apr, 2024 (17 days ago)
US10376584	SALIX PHARMS	Stable pharmaceutical formulations of methylnaltrexone	Apr, 2024 (17 days ago)
US9669096	SALIX PHARMS	Stable pharmaceutical formulations of methylnaltrexone	Apr, 2024 (17 days ago)
US8420663	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8822490	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9492445	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9180125	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8247425	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Dec, 2030 (6 years from now)

Relistor is owned by Salix Pharms.

Relistor contains Methylnaltrexone Bromide.

Relistor has a total of 9 drug patents out of which 4 drug patents have expired.

Expired drug patents of Relistor are:

Relistor was authorised for market use on 27 September, 2010.

Relistor is available in solution;subcutaneous dosage forms.

Relistor can be used as treatment of opioid-induced constipation.

Drug patent challenges can be filed against Relistor from 24 April, 2012.

The generics of Relistor are possible to be released after 31 December, 2030.

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 24, 2013

NCE-1 date: 24 April, 2012

Market Authorisation Date: 27 September, 2010

Treatment: Treatment of opioid-induced constipation

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
12 mg/0.6 mL	22 Jul, 2015	1	31 Dec, 2030
8 mg/0.4 mL	08 Sep, 2015	1	31 Dec, 2030
150 mg	06 Sep, 2016	1	10 Mar, 2031

Strength	Dosage	Availability
12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription
8MG/0.4ML (8MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription

RELISTOR family patents

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).
US6559158	SALIX	Use of methylnaltrexone and related compounds to treat chronic opioid use side affects	Nov, 2017 (6 years ago)
US8420663	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9724343	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9180125	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9492445	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8524276	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)
US10307417	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)
US8956651	SALIX	Oral formulations and lipophilic salts of methylnal trexone	Mar, 2031 (6 years from now)
US9314461	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)
US10376505	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)

Relistor is owned by Salix.

Relistor contains Methylnaltrexone Bromide.

Relistor has a total of 10 drug patents out of which 1 drug patent has expired.

Expired drug patents of Relistor are:

Relistor was authorised for market use on 19 July, 2016.

Relistor is available in tablet;oral dosage forms.

Relistor can be used as treatment of opioid-induced constipation.

The generics of Relistor are possible to be released after 10 March, 2031.

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jul 19, 2019

Market Authorisation Date: 19 July, 2016

Treatment: Treatment of opioid-induced constipation

Dosage: TABLET;ORAL