Follitropin beta - Biologic Drug Details

Summary for follitropin beta

Tradenames:	3
High Confidence Patents:	4
Applicants:	2
BLAs:	3
Suppliers: see list	2

Pharmacology for follitropin beta

Established Pharmacologic Class	Gonadotropin
Chemical Structure	Gonadotropins

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for follitropin beta Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for follitropin beta Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2015-06-16	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2017-01-15	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2018-07-23	Company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2018-07-23	Company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2017-01-15	Company disclosures

3) Low Certainty: US Patents for follitropin beta Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2033-03-11	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2024-12-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2029-05-13	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2029-01-29	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2037-01-05	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2038-07-09	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582			Patent claims search

International Patents for follitropin beta

Country	Patent Number	Estimated Expiration
Australia	5205998
Canada	2226803
Netherlands	960004
Hungary	9800056
Hong Kong	1026615
Germany	3485869
Japan	2559196

Supplementary Protection Certificates for follitropin beta

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122010000011	Germany		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
SZ 17/2001	Austria		PRODUCT NAME: CHORIOGONADOTROPHIN ALFA
SPC/GB01/030	United Kingdom		PRODUCT NAME: RECOMBINANT CHORIOGONADOTROPIN ALFA; REGISTERED: UK EU/1/00/165/001-006 20010202
SZ 6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA
C960004	Netherlands		PRODUCT NAME: RECOMBINANT HUMAAN FOLLIKELSTIMULEREND HORMOON; REGISTRATION NO/DATE: EU/1/95/001/001 - EU/1/95/001/016 19951020
SZ 5/1996	Austria		PRODUCT NAME: REKOMBINANTES HUMANES FOLLIKELSTIMULIERENDES HORMON
6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125