ACTELION Company Profile
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What is the competitive landscape for ACTELION, and when can generic versions of ACTELION drugs launch?
ACTELION has nine approved drugs.
There are fifteen US patents protecting ACTELION drugs.
There are two hundred and fifty patent family members on ACTELION drugs in thirty-nine countries and thirty-four supplementary protection certificates in seventeen countries.
Summary for ACTELION
| International Patents: | 250 |
| US Patents: | 15 |
| Tradenames: | 7 |
| Ingredients: | 7 |
| NDAs: | 9 |
| PTAB Cases with ACTELION as petitioner: | See PTAB cases with ACTELION as petitioner |
Drugs and US Patents for ACTELION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion | UPTRAVI | selexipag | TABLET;ORAL | 207947-006 | Dec 21, 2015 | RX | Yes | No | 9,284,280 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actelion | UPTRAVI | selexipag | TABLET;ORAL | 207947-008 | Dec 21, 2015 | AB | RX | Yes | No | 10,828,298 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Actelion | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | 9,265,762 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-002 | Mar 22, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ACTELION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | 5,472,969 | ⤷ Sign Up |
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | 5,292,740 | ⤷ Sign Up |
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | 5,292,740 | ⤷ Sign Up |
| Actelion | ZAVESCA | miglustat | CAPSULE;ORAL | 021348-001 | Jul 31, 2003 | 5,525,616 | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for ACTELION drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | 2017-10-18 |
| ➤ Subscribe | for Oral Suspension | 32 mg | ➤ Subscribe | 2019-02-08 |
International Patents for ACTELION Drugs
Supplementary Protection Certificates for ACTELION Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1400518 | 16C0042 | France | ⤷ Sign Up | PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519 |
| 1345920 | 132014902244514 | Italy | ⤷ Sign Up | PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220 |
| 1400518 | 1690044-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519 |
| 0526708 | 02C0042 | France | ⤷ Sign Up | PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
