Tybost is a drug owned by Gilead Sciences Inc. It is protected by 4 US drug patents filed from 2014 to 2021 out of which none have expired yet. Tybost's patents have been open to challenges since 27 August, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2033. Details of Tybost's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8148374 | Modulators of pharmacokinetic properties of therapeutics |
Sep, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10039718 (Pediatric) | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Apr, 2033
(8 years from now) | Active |
| US10039718 | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Oct, 2032
(7 years from now) | Active |
|
US8148374 (Pediatric) | Modulators of pharmacokinetic properties of therapeutics |
Mar, 2030
(5 years from now) | Active |
FDA has granted several exclusivities to Tybost. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tybost, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tybost.
Exclusivity Information
Tybost holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Tybost's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2017 |
| New Product(NP) | Sep 24, 2017 |
| New Patient Population(NPP) | Aug 22, 2022 |
| Orphan Drug Exclusivity(ODE-260) | Aug 22, 2026 |
Several oppositions have been filed on Tybost's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tybost's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tybost patents.
Tybost's Oppositions Filed in EPO
Tybost has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 16, 2016, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP07836007A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16180589A | Oct, 2020 | Cooke, Richard | Granted and Under Opposition |
| EP16180589A | Oct, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP16180589A | Jan, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP12167591A | May, 2017 | Cooke, Richard | Revoked |
| EP12167590A | May, 2017 | Cooke, Richard | Revoked |
| EP12167590A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167591A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167589A | May, 2017 | Cooke, Richard | Granted and Under Opposition |
| EP12167589A | May, 2017 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP12167596A | Apr, 2017 | Cooke, Richard | Revoked |
| EP12167596A | Apr, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP09739981A | Jun, 2016 | Cooke, Richard | Revoked |
| EP09739981A | Jun, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP10703766A | Apr, 2016 | Cooke, Richard | Revoked |
| EP10703766A | Apr, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP07836007A | Mar, 2016 | Trösch, Dominique | Granted and Under Opposition |
| EP07836007A | Mar, 2016 | Georg Kalhammer/Stephan Teipel | Granted and Under Opposition |
| EP07836007A | Mar, 2016 | Teva Pharmaceutical Industries LTD. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tybost 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 Tybost's family patents as well as insights into ongoing legal events on those patents.
Tybost's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tybost's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tybost Generic API suppliers:
Cobicistat is the generic name for the brand Tybost. 1 company has already filed for the generic of Tybost. Check out the entire list of companies who have already received approval for Tybost's generic
How can I launch a generic of Tybost before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tybost's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tybost'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 Tybost -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg | 14 Nov, 2016 | 1 | 03 Sep, 2029 |
Alternative Brands for Tybost
Tybost which is used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase., has several other brand drugs in the same treatment category and using the same active ingredient (Cobicistat). 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 | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Bristol |
| |||||
| Gilead Sciences Inc |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Cobicistat. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Cobicistat, Tybost's active ingredient. Check the complete list of approved generic manufacturers for Tybost
About Tybost
Tybost is a drug owned by Gilead Sciences Inc. It is used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase. Tybost uses Cobicistat as an active ingredient. Tybost was launched by Gilead Sciences Inc in 2014.
Approval Date:
Tybost was approved by FDA for market use on 24 September, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tybost is 24 September, 2014, its NCE-1 date is estimated to be 27 August, 2016.
Active Ingredient:
Tybost uses Cobicistat as the active ingredient. Check out other Drugs and Companies using Cobicistat ingredient
Treatment:
Tybost is used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
Dosage:
Tybost is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |