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-nine patent family members on SALIX drugs in fifty-five countries and ninety-seven supplementary protection certificates in twelve countries.
Summary for SALIX
| International Patents: | 649 |
| 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 | MOVIPREP | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 021881-001 | Aug 2, 2006 | AA | RX | Yes | Yes | 7,658,914 | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | AB | RX | Yes | Yes | 8,865,688 | ⤷ Sign Up | ⤷ Sign Up | |||
| Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 8,420,663 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | RX | Yes | Yes | 9,492,445 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 9,724,343 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 8,158,644 | ⤷ Sign Up | Y | ⤷ 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 SALIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-002 | Feb 27, 2006 | 6,489,346 | ⤷ Sign Up |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | 8,784,888 | ⤷ Sign Up |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | 6,780,882 | ⤷ Sign Up |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | 9,669,096 | ⤷ Sign Up |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | 10,064,878 | ⤷ Sign Up |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | 9,532,954 | ⤷ Sign Up |
| >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 | 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 |
| ➤ 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 |
International Patents for SALIX Drugs
Supplementary Protection Certificates for SALIX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 0957929 | 06C0021 | France | ⤷ Sign Up | PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131 |
| 0454511 | SPC/GB99/008 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 |
| 1856135 | CR 2020 00018 | Denmark | ⤷ Sign Up | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
| 1499331 | 13C0055 | France | ⤷ Sign Up | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220 |
| 2822954 | 1890030-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
| >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.
