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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 2017

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Actelion Pharms Ltd Company Profile

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What is the competitive landscape for ACTELION PHARMS LTD, and what generic alternatives to ACTELION PHARMS LTD drugs are available?

ACTELION PHARMS LTD has seven approved drugs.

There are sixteen US patents protecting ACTELION PHARMS LTD drugs.

There are one hundred and eighty-seven patent family members on ACTELION PHARMS LTD drugs in thirty-seven countries.

Summary for Applicant: Actelion Pharms Ltd

Patents:16
Tradenames:7
Ingredients:7
NDAs:7
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-008Dec 21, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-002Nov 20, 2001RXYesYes► Subscribe► Subscribe► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-002Dec 21, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-002Dec 21, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-008Dec 21, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-007Dec 21, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Actelion Pharms Ltd
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL202317-001Aug 23, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-005Dec 21, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Actelion Pharms Ltd
OPSUMIT
macitentan
TABLET;ORAL204410-001Oct 18, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-003Dec 21, 2015RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Actelion Pharms Ltd

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd
ZAVESCA
miglustat
CAPSULE;ORAL021348-001Jul 31, 2003► Subscribe► Subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-002Nov 20, 2001► Subscribe► Subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-001Nov 20, 2001► Subscribe► Subscribe
Actelion Pharms Ltd
ZAVESCA
miglustat
CAPSULE;ORAL021348-001Jul 31, 2003► Subscribe► Subscribe
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Non-Orange Book Patents for Actelion Pharms Ltd

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,597,331Therapeutic compositions containing macitentan► Subscribe
7,285,549Sulfamides and their use as endothelin receptor antagonists► Subscribe
2,013,210,830► Subscribe
8,664,278Stabilized compositions of volatile alkylating agents and methods of using thereof► Subscribe
9,440,931Form-III crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and use thereof► Subscribe
8,501,817Stabilized compositions of alkylating agents and methods of using same► Subscribe
8,809,334Therapeutic compositions containing macitentan► Subscribe
2,010,029,783► Subscribe
9,340,516Form-II crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl) acetamide, method for producing the same, and use thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Actelion Pharms Ltd Drugs

Country Document Number Estimated Expiration
South Korea20120109457► Subscribe
Russian Federation2283835► Subscribe
South Korea101351668► Subscribe
Cyprus1113305► Subscribe
Mexico2009002057► Subscribe
Australia2006290309► Subscribe
SloveniaEP1858864► Subscribe
Portugal1928409► Subscribe
Japan2004517855► Subscribe
Slovenia1993557► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Actelion Pharms Ltd Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0042France► SubscribePRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
C0017France► SubscribePRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
0672Netherlands► SubscribePRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
00097Netherlands► SubscribePRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
266Luxembourg► SubscribePRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
2016 00048Denmark► SubscribePRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
0836Netherlands► SubscribePRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
C0042France► SubscribePRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2016000077Germany► SubscribePRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512
2017026Lithuania► SubscribePRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

Covington
Mallinckrodt
US Army
Colorcon
Medtronic
Cantor Fitzgerald
US Department of Justice
Citi
QuintilesIMS
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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