Sandostatin is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 19, 2015. Details of Sandostatin's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US5753618 (Pediatric) | Somatostatin analogue composition and use in treating breast cancer |
Nov, 2015
(9 years ago) |
Expired
|
| US5753618 | Somatostatin analogue composition and use in treating breast cancer |
May, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Sandostatin is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Sandostatin's family patents as well as insights into ongoing legal events on those patents.
Sandostatin's Family Patents
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Generic Launch
Generic Release Date:
Sandostatin's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 19, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sandostatin Generic API suppliers:
Octreotide Acetate is the generic name for the brand Sandostatin. 11 different companies have already filed for the generic of Sandostatin, with Sun Pharm Inds having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sandostatin's generic
How can I launch a generic of Sandostatin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sandostatin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sandostatin's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Sandostatin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 mg /mL, 0.1 mg /mL and 0.5 mg/mL, 1 mL vials | |||||
| 0.2 mg/mL and 1 mg /mL, 5 mL vials | |||||
| 0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative-free) | 17 Jan, 2008 | 1 | 10 Feb, 2011 | 19 May, 2015 | Extinguished Eligible |
Alternative Brands for Sandostatin
There are several other brand drugs using the same active ingredient (Octreotide Acetate) as Sandostatin. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Chiesi |
| |
| Novartis |
| |
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Octreotide Acetate, Sandostatin's active ingredient. Check the complete list of approved generic manufacturers for Sandostatin
About Sandostatin
Sandostatin is a drug owned by Novartis Pharmaceuticals Corp. Sandostatin uses Octreotide Acetate as an active ingredient. Sandostatin was launched by Novartis in 1988.
Approval Date:
Sandostatin was approved by FDA for market use on 21 October, 1988.
Active Ingredient:
Sandostatin uses Octreotide Acetate as the active ingredient. Check out other Drugs and Companies using Octreotide Acetate ingredient
Dosage:
Sandostatin is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.05MG BASE/ML | INJECTABLE | Prescription | INJECTION |
| EQ 0.5MG BASE/ML | INJECTABLE | Prescription | INJECTION |
| EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| EQ 0.1MG BASE/ML | INJECTABLE | Prescription | INJECTION |