SALIX Company Profile
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What is the competitive landscape for SALIX, and when can generic versions of SALIX drugs launch?
SALIX has eighteen approved drugs.
There are seventy-five US patents protecting SALIX drugs.
There are six hundred and forty-seven patent family members on SALIX drugs in fifty-five countries and ninety-seven supplementary protection certificates in twelve countries.
Summary for SALIX
| International Patents: | 647 |
| US Patents: | 75 |
| Tradenames: | 15 |
| Ingredients: | 13 |
| NDAs: | 18 |
| Patent Litigation for SALIX: | See patent lawsuits for SALIX |
| PTAB Cases with SALIX as patent owner: | See PTAB cases with SALIX as patent owner |
Drugs and US Patents for SALIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | RX | Yes | Yes | 8,552,025 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | RX | Yes | Yes | 9,180,125 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 8,835,452 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | 9,616,097 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | RX | Yes | Yes | 10,376,584 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | AB | RX | Yes | Yes | 10,660,858 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Salix | PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381-001 | May 4, 2018 | RX | Yes | Yes | 9,707,297 | ⤷ 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 SALIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | 8,552,025 | ⤷ Try a Trial |
| Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | 8,337,886 | ⤷ Try a Trial |
| Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | 8,496,965 | ⤷ Try a Trial |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | 6,645,988 | ⤷ Try a Trial |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | 9,669,096 | ⤷ Try a Trial |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | 9,669,096 | ⤷ Try a Trial |
| Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | 8,911,778 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for SALIX drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | For Oral Solution | 100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch | ➤ Subscribe | 2007-11-27 |
| ➤ Subscribe | Tablets | 1.102 g and 0.398 g | ➤ Subscribe | 2008-04-09 |
| ➤ Subscribe | Tablets | 200 mg | ➤ Subscribe | 2019-01-28 |
| ➤ Subscribe | Extended-release Capsules | 0.375 g | ➤ Subscribe | 2012-04-03 |
| ➤ Subscribe | Powder for Oral Suspension | 40 mg/1680 mg per packet | ➤ Subscribe | 2007-08-24 |
| ➤ Subscribe | For Oral Solution | 140 g, 5.2 g, 2.2.g, 48.11 g, 9g and 7.54 g per pouch | ➤ Subscribe | 2018-12-06 |
| ➤ Subscribe | Injection | 12 mg/0.6 mL | ➤ Subscribe | 2015-07-22 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2016-09-06 |
| ➤ Subscribe | Orally Disintegrating Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-08-24 |
| ➤ Subscribe | Tablets | 550 mg | ➤ Subscribe | 2015-12-18 |
| ➤ Subscribe | Extended-release Tablets | 9 mg | ➤ Subscribe | 2013-03-11 |
| ➤ Subscribe | Capsules | 20 mg/1100 mg and 40 mg/1100 mg | ➤ Subscribe | 2007-04-30 |
| ➤ Subscribe | Powder for Oral Suspension | 20mg/1680mg per packet | ➤ Subscribe | 2007-11-13 |
| ➤ Subscribe | Tablets | 40 mg and 120 mg | ➤ Subscribe | 2010-03-17 |
| ➤ Subscribe | Injection | 8 mg/0.4 mL | ➤ Subscribe | 2015-09-08 |
International Patents for SALIX Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5279851 | ⤷ Try a Trial |
| Portugal | 2350096 | ⤷ Try a Trial |
| Denmark | 1567193 | ⤷ Try a Trial |
| Japan | 2014177500 | ⤷ Try a Trial |
| Morocco | 29345 | ⤷ Try a Trial |
| Norway | 334950 | ⤷ Try a Trial |
| Spain | 2244364 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SALIX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2822954 | 1890030-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
| 2673237 | 1990016-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326 |
| 2203431 | CR 2015 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 2673237 | LUC00111 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326 |
| 0806968 | SPC/GB07/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 |
| 0186405 | SPC/GB00/021 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316 |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >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.
