COVIS Company Profile
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What is the competitive landscape for COVIS, and when can generic versions of COVIS drugs launch?
COVIS has eleven approved drugs.
There are five US patents protecting COVIS drugs.
There are one hundred and forty-four patent family members on COVIS drugs in forty-six countries and twenty-seven supplementary protection certificates in fourteen countries.
Summary for COVIS
| International Patents: | 144 |
| US Patents: | 5 |
| Tradenames: | 12 |
| Ingredients: | 9 |
| NDAs: | 11 |
Drugs and US Patents for COVIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-001 | Feb 2, 1995 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-008 | Jan 2, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | Yes | Yes | RE46417 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Covis | LANOXIN | digoxin | INJECTABLE;INJECTION | 009330-002 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-007 | Jan 2, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | 11,000,517 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 COVIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | 5,695,743 | ⤷ Try a Trial |
| Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | 5,775,321 | ⤷ Try a Trial |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | 6,428,810 | ⤷ Try a Trial |
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | 8,129,405 | ⤷ Try a Trial |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-001 | Feb 2, 1995 | 4,703,038 | ⤷ Try a Trial |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | 6,681,768 | ⤷ Try a Trial |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | 5,900,424 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for COVIS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Nasal Spray | 250 mcg | ➤ Subscribe | 2012-02-13 |
| ➤ Subscribe | Extended-release Tablets | 25.5 mg and 34 mg | ➤ Subscribe | 2008-11-28 |
| ➤ Subscribe | Extended-release Tablets | 8.5 mg and 17 mg | ➤ Subscribe | 2009-03-02 |
| ➤ Subscribe | Injection | 30 mg/mL, 17 mL single-use vials | ➤ Subscribe | 2015-12-04 |
| ➤ Subscribe | Extended-release Tablets | 20 mg and 30 mg | ➤ Subscribe | 2007-11-07 |
| ➤ Subscribe | Extended-release Tablets | 40 mg | ➤ Subscribe | 2007-06-11 |
International Patents for COVIS Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2010008235 | ⤷ Try a Trial |
| Egypt | 24066 | ⤷ Try a Trial |
| Czech Republic | 2002121 | ⤷ Try a Trial |
| Cyprus | 1117371 | ⤷ Try a Trial |
| Slovakia | 432002 | ⤷ Try a Trial |
| Uruguay | 26244 | ⤷ Try a Trial |
| Poland | 1670482 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for COVIS Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1200431 | SPC/GB13/006 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720 |
| 1200431 | 2013C/001 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT EN PARTICULIER LE BROMURE D'ACLIDINIUM; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725 |
| 1200431 | PA2013001,C1200431 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720 |
| 1200431 | 2013/002 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 20120720 |
| 1200431 | PA2013001 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720 |
| 1169062 | 2012C/052 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
| 1169062 | C01169062/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
