Givlaari is a drug owned by Alnylam Pharmaceuticals Inc. It is protected by 14 US drug patents filed from 2019 to 2022. Out of these, 9 drug patents are active and 5 have expired. Givlaari's patents have been open to challenges since 21 November, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 03, 2034. Details of Givlaari's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8546143 | Compositions and methods for inhibiting expression of a target gene |
Jan, 2022
(2 years ago) |
Expired
|
| US9708610 | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Jan, 2024
(8 months ago) |
Expired
|
| US10273477 | Therapeutic compositions |
Mar, 2024
(6 months ago) |
Expired
|
| US9708615 | Therapeutic compositions |
Mar, 2024
(6 months ago) |
Expired
|
| US11530408 | Therapeutic compositions |
May, 2024
(3 months ago) |
Expired
|
| US9150605 | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Aug, 2025
(11 months from now) | Active |
| US10131907 | Glycoconjugates of RNA interference agents |
Aug, 2028
(3 years from now) | Active |
| US8828956 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(4 years from now) | Active |
| US8106022 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(5 years from now) | Active |
| US10125364 | Compositions and methods for inhibiting expression of the ALAS1 gene |
Mar, 2033
(8 years from now) | Active |
| US9133461 | Compositions and methods for inhibiting expression of the ALAS1 gene |
Nov, 2033
(9 years from now) | Active |
| US10119143 | Compositions and methods for inhibiting expression of the ALAS1 gene |
Oct, 2034
(10 years from now) | Active |
| US11028392 | Compositions and methods for inhibiting expression of the ALAS1 gene |
Oct, 2034
(10 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9631193 | Compositions and methods for inhibiting expression of the ALAS1 gene |
Mar, 2033
(8 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Givlaari's patents.
Latest Legal Activities on Givlaari's Patents
Given below is the list of recent legal activities going on the following patents of Givlaari.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8828956 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8828956 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US8106022 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 31 Jul, 2023 | US8106022 |
| Second letter to regulating agency to determine regulatory review period | 13 Jun, 2023 | US8828956 |
| Patent Term Extension Certificate Critical | 25 May, 2023 | US9133461 |
| Email Notification Critical | 22 Mar, 2023 | US11530408 |
| Mail Certificate of Correction Memo | 21 Mar, 2023 | US11530408 |
| Certificate of Correction Memo | 20 Mar, 2023 | US11530408 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Mar, 2023 | US9133461 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Givlaari and ongoing litigations to help you estimate the early arrival of Givlaari generic.
Givlaari's Litigations
Givlaari has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 22, 2010, against patent number US9150605. The petitioner , challenged the validity of this patent, with Charles Allerson et al as the respondent. Click below to track the latest information on how companies are challenging Givlaari's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9150605 | November, 2010 |
Decision
(27 Feb, 2013) | Charles Allerson et al | |
FDA has granted some exclusivities to Givlaari. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Givlaari, 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 Givlaari.
Exclusivity Information
Givlaari holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Givlaari's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 20, 2024 |
| Orphan Drug Exclusivity(ODE-273) | Nov 20, 2026 |
Several oppositions have been filed on Givlaari'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 Givlaari's generic, the next section provides detailed information on ongoing and past EP oppositions related to Givlaari patents.
Givlaari's Oppositions Filed in EPO
Givlaari has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 20, 2003, by Sirna Therapeutics, Inc.. This opposition was filed on patent number EP00910510A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06025389A | Dec, 2017 | Silence Therapeutics GmbH | Revoked |
| EP10011217A | Apr, 2017 | Silence Therapeutics GmbH | Opposition rejected |
| EP02702247A | Dec, 2010 | Silence Therapeutics AG | Revoked |
| EP02702247A | Dec, 2010 | Sirna Therapeutics | Revoked |
| EP05002454A | Sep, 2009 | ROQUES, Sarah Elizabeth | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | Silence Therapeutics AG | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | PFIZER LIMITED | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | Sanofi-Aventis Deutschland GmbH | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | Sirna Therapeutics | Granted and Under Opposition |
| EP02710786A | Feb, 2007 | Sirna Therapeutics | Opposition rejected |
| EP02003683A | Mar, 2006 | atugen AG | Patent maintained as amended |
| EP02003683A | Mar, 2006 | Abbott Laboratories | Patent maintained as amended |
| EP02003683A | Mar, 2006 | Sirna Therapeutics, Inc. | Patent maintained as amended |
| EP02003683A | Mar, 2006 | Quark Biotech, Inc. | Patent maintained as amended |
| EP00910510A | May, 2003 | atugen AG | Revoked |
| EP00910510A | May, 2003 | Aventis Pharma Deutschland GmbH | Revoked |
| EP00910510A | May, 2003 | Grund, Martin, Dr. | Revoked |
| EP00910510A | May, 2003 | JANSSEN PHARMACEUTICA N.V. | Revoked |
| EP00910510A | May, 2003 | AstraZeneca AB | Revoked |
| EP00910510A | May, 2003 | Novartis AG | Revoked |
| EP00910510A | May, 2003 | Isis Pharmaceuticals, Inc. | Revoked |
| EP00910510A | May, 2003 | Sirna Therapeutics, Inc. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Givlaari 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 Givlaari's family patents as well as insights into ongoing legal events on those patents.
Givlaari's Family Patents
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Generic Launch
Generic Release Date:
Givlaari's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 03, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Givlaari Generics:
There are no approved generic versions for Givlaari as of now.
About Givlaari
Givlaari is a drug owned by Alnylam Pharmaceuticals Inc. It is used for treating acute hepatic porphyria. Givlaari uses Givosiran Sodium as an active ingredient. Givlaari was launched by Alnylam Pharms Inc in 2019.
Can you believe Givlaari received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Givlaari was approved by FDA for market use on 20 November, 2019.
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 Givlaari is 20 November, 2019, its NCE-1 date is estimated to be 21 November, 2023.
Active Ingredient:
Givlaari uses Givosiran Sodium as the active ingredient. Check out other Drugs and Companies using Givosiran Sodium ingredient
Treatment:
Givlaari is used for treating acute hepatic porphyria.
Dosage:
Givlaari is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 189MG BASE/ML (EQ 189MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |