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Generic Onpattro Availability

Onpattro is a brand name of patisiran, approved by the FDA in the following formulation(s):

ONPATTRO (patisiran sodium - solution;intravenous)

  • Manufacturer: ALNYLAM PHARMS INC
    Approval date: August 10, 2018
    Strength(s): EQ 10MG BASE/5ML (EQ 2MG BASE/ML) [RLD]

Has a generic version of Onpattro been approved?

No. There is currently no therapeutically equivalent version of Onpattro available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Onpattro. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Lipid formulations for nucleic acid delivery
    Patent 8,058,069
    Issued: November 15, 2011
    Inventor(s): Yaworski; Edward & Lam; Kieu & Jeffs; Lloyd & Palmer; Lorne & MacLachlan; Ian
    Assignee(s): Protiva Biotherapeutics, Inc.

    The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.

    Patent expiration dates:

    • April 15, 2029
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      Drug product
  • Lipid formulation
    Patent 8,158,601
    Issued: April 17, 2012
    Inventor(s): Chen; Jianxin & Ansell; Steven & Akinc; Akin & Dorkin; Joseph Robert & Qin; Xiaojun & Cantley; William & Manoharan; Muthiah & Rajeev; Kallanthottathil G. & Narayanannair; Jayaprakash K. & Jayaraman; Muthusamy
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention features a cationic lipid of formula I, an improved lipid formulation comprising a cationic lipid of formula I and corresponding methods of use. Also disclosed are targeting lipids, and specific lipid formulations comprising such targeting lipids.

    Patent expiration dates:

    • November 10, 2030
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      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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      Drug product
  • Compositions and methods for inhibiting expression of transthyretin
    Patent 8,168,775
    Issued: May 1, 2012
    Inventor(s): Sah; Dinah Wen-Yee & Hinkle; Gregory & Alvarez; Rene & Milstein; Stuart & Chen; Qingmin
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.

    Patent expiration dates:

    • October 20, 2029
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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      Drug substance
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      Drug product
  • Nuclease resistant double-stranded ribonucleic acid
    Patent 8,334,373
    Issued: December 18, 2012
    Inventor(s): Vornlocher; Hans-Peter & Roehl; Ingo & Hadwiger; Philipp & Zimmermann; Tracy Stage & Manoharan; Muthiah & Rajeev; Kallanthottathil G. & Akinc; Akin
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    This invention relates to modified double-stranded oligoribonucleic acid (dsRNA) having improved stability in cells and biological fluids, and methods of making and identifying dsRNA having improved stability, and of using the dsRNA to inhibit the expression or function of a target gene.

    Patent expiration dates:

    • May 27, 2025
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      Drug substance
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      Drug product
  • RNA interference mediating small RNA molecules
    Patent 8,362,231
    Issued: January 29, 2013
    Assignee(s): Max-Planck-Gesellschaft zur Föderung der Wissenschaften E.V. Massachusetts Institute of Technology Whitehead Institute for Biomedical Research University of Massachusetts

    Double-stranded RNA (dsRNA) induces sequence-specific post-transcriptional gene silencing in many organisms by a process known as RNA interference (RNAi). Using a Drosophila in vitro system, we demonstrate that 19-23 nt short RNA fragments are the sequence-specific mediators of RNAi. The short interfering RNAs (siRNAs) are generated by an RNase III-like processing reaction from long dsRNA. Chemically synthesized siRNA duplexes with overhanging 3′ ends mediate efficient target RNA cleavage in the lysate, and the cleavage site is located near the center of the region spanned by the guiding siRNA. Furthermore, we provide evidence that the direction of dsRNA processing determines whether sense or antisense target RNA can be cleaved by the produced siRNP complex.

    Patent expiration dates:

    • March 30, 2021
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      Drug substance
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      Drug product
  • RNA interference mediating small RNA molecules
    Patent 8,372,968
    Issued: February 12, 2013
    Assignee(s): Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. Massachusetts Institute of Technology Whitehead Institute for Biomedical Research University of Massachusetts

    Double-stranded RNA (dsRNA) induces sequence-specific post-transcriptional gene silencing in many organisms by a process known as RNA interference (RNAi). Using a Drosophila in vitro system, we demonstrate that 19-23 nt short RNA fragments are the sequence-specific mediators of RNAi. The short interfering RNAs (siRNAs) are generated by an RNase III-like processing reaction from long dsRNA. Chemically synthesized siRNA duplexes with overhanging 3′ ends mediate efficient target RNA cleavage in the lysate, and the cleavage site is located near the center of the region spanned by the guiding siRNA. Furthermore, we provide evidence that the direction of dsRNA processing determines whether sense or antisense target RNA can be cleaved by the produced siRNP complex.

    Patent expiration dates:

    • March 30, 2021
      ✓ 
      Drug substance
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      Drug product
  • Lipid formulations for nucleic acid delivery
    Patent 8,492,359
    Issued: July 23, 2013
    Assignee(s): Protiva Biotherapeutics, Inc.

    The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.

    Patent expiration dates:

    • April 15, 2029
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      Drug product
  • RNA sequence-specific mediators of RNA interference
    Patent 8,552,171
    Issued: October 8, 2013
    Assignee(s): University of Massachusetts Whitehead Insititute for Biomedical Research Massachusetts Institute of Technology Max-Planck-Gesellschaft zur Föderung der Wissenschaften E.V.

    The present invention relates to a Drosophila in vitro system which was used to demonstrate that dsRNA is processed to RNA segments 21-23 nucleotides (nt) in length. Furthermore, when these 21-23 nt fragments are purified and added back to Drosophila extracts, they mediate RNA interference in the absence of long dsRNA. Thus, these 21-23 nt fragments are the sequence-specific mediators of RNA degradation. A molecular signal, which may be their specific length, must be present in these 21-23 nt fragments to recruit cellular factors involved in RNAi. This present invention encompasses these 21-23 nt fragments and their use for specifically inactivating gene function. The use of these fragments (or chemically synthesized oligonucleotides of the same or similar nature) enables the targeting of specific mRNAs for degradation in mammalian cells, where the use of long dsRNAs to elicit RNAi is usually not practical, presumably because of the deleterious effects of the interferon response. This specific targeting of a particular gene function is useful in functional genomic and therapeutic applications.

    Patent expiration dates:

    • March 30, 2021
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Lipid containing formulations
    Patent 8,642,076
    Issued: February 4, 2014
    Assignee(s): Tekmira Pharmaceuticals Corporation

    Compositions and methods useful in administering nucleic acid based therapies, for example association complexes such as liposomes and lipoplexes are described.

    Patent expiration dates:

    • October 3, 2027
      ✓ 
      Drug product
  • Compositions and methods for inhibiting expression of transthyretin
    Patent 8,741,866
    Issued: June 3, 2014
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.

    Patent expiration dates:

    • October 20, 2029
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
  • RNA interference mediating small RNA molecules
    Patent 8,778,902
    Issued: July 15, 2014
    Assignee(s): Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. Massachusetts Intitute of Technology Whitehead Institute for Biomedical Research University of Massachusetts

    Double-stranded RNA (dsRNA) induces sequence-specific post-transcriptional gene silencing in many organisms by a process known as RNA interference (RNAi). Using a Drosophila in vitro system, we demonstrate that 19-23 nt short RNA fragments are the sequence-specific mediators of RNAi. The short interfering RNAs (siRNAs) are generated by an RNase III-like processing reaction from long dsRNA. Chemically synthesized siRNA duplexes with overhanging 3′ ends mediate efficient target RNA cleavage in the lysate, and the cleavage site is located near the center of the region spanned by the guiding siRNA. Furthermore, we provide evidence that the direction of dsRNA processing determines whether sense or antisense target RNA can be cleaved by the produced siRNP complex.

    Patent expiration dates:

    • March 30, 2021
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
  • Lipid formulation
    Patent 8,802,644
    Issued: August 12, 2014
    Assignee(s): Tekmira Pharmaceuticals Corporation

    The invention features a cationic lipid of formula I, an improved lipid formulation comprising a cationic lipid of formula I and corresponding methods of use. Also disclosed are targeting lipids, and specific lipid formulations comprising such targeting lipids.

    Patent expiration dates:

    • October 21, 2030
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
      ✓ 
      Drug product
  • Lipid formulations for nucleic acid delivery
    Patent 8,822,668
    Issued: September 2, 2014
    Assignee(s): Protiva Biotherapeutics, Inc.

    The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.

    Patent expiration dates:

    • April 15, 2029
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
      ✓ 
      Drug product
  • RNA interference mediating small RNA molecules
    Patent 8,895,718
    Issued: November 25, 2014
    Assignee(s): Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. Massachusetts Institute of Technology Whitehead Institute for Biomedical Research University of Massachusetts

    Double-stranded RNA (dsRNA) induces sequence-specific post-transcriptional gene silencing in many organisms by a process known as RNA interference (RNAi). Using a Drosophila in vitro system, we demonstrate that 19-23 nt short RNA fragments are the sequence-specific mediators of RNAi. The short interfering RNAs (siRNAs) are generated by an RNase III-like processing reaction from long dsRNA. Chemically synthesized siRNA duplexes with overhanging 3′ ends mediate efficient target RNA cleavage in the lysate, and the cleavage site is located near the center of the region spanned by the guiding siRNA. Furthermore, we provide evidence that the direction of dsRNA processing determines whether sense or antisense target RNA can be cleaved by the produced siRNP complex.

    Patent expiration dates:

    • March 30, 2021
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • RNA interference mediating small RNA molecules
    Patent 8,895,721
    Issued: November 25, 2014
    Assignee(s): Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. Massachusetts Institute of Technology Whitehead Institute for Biomedical Research University of Massachusetts

    Double-stranded RNA (dsRNA) induces sequence-specific post-transcriptional gene silencing in many organisms by a process known as RNA interference (RNAi). Using a Drosophila in vitro system, we demonstrate that 19-23 nt short RNA fragments are the sequence-specific mediators of RNAi. The short interfering RNAs (siRNAs) are generated by an RNase III-like processing reaction from long dsRNA. Chemically synthesized siRNA duplexes with overhanging 3′ ends mediate efficient target RNA cleavage in the lysate, and the cleavage site is located near the center of the region spanned by the guiding siRNA. Furthermore, we provide evidence that the direction of dsRNA processing determines whether sense or antisense target RNA can be cleaved by the produced siRNP complex.

    Patent expiration dates:

    • March 30, 2021
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • RNA sequence-specific mediators of RNA interference
    Patent 9,193,753
    Issued: November 24, 2015
    Assignee(s): University of Massachusetts Whitehead Institute for Biomedical Research Massachusetts Institute of Technology Max-Planck-Gesellschaft Zur Förderung Der Wissenschaften E.V.

    The present invention relates to a Drosophila in vitro system which was used to demonstrate that dsRNA is processed to RNA segments 21-23 nucleotides (nt) in length. Furthermore, when these 21-23 nt fragments are purified and added back to Drosophila extracts, they mediate RNA interference in the absence of long dsRNA. Thus, these 21-23 nt fragments are the sequence-specific mediators of RNA degradation. A molecular signal, which may be their specific length, must be present in these 21-23 nt fragments to recruit cellular factors involved in RNAi. This present invention encompasses these 21-23 nt fragments and their use for specifically inactivating gene function. The use of these fragments (or chemically synthesized oligonucleotides of the same or similar nature) enables the targeting of specific mRNAs for degradation in mammalian cells, where the use of long dsRNAs to elicit RNAi is usually not practical, presumably because of the deleterious effects of the interferon response. This specific targeting of a particular gene function is useful in functional genomic and therapeutic applications.

    Patent expiration dates:

    • March 30, 2021
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
  • Compositions and methods for inhibiting expression of transthyretin
    Patent 9,234,196
    Issued: January 12, 2016
    Assignee(s): Alnylam Pharmaceuticals, Inc.

    The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.

    Patent expiration dates:

    • October 20, 2029
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
      ✓ 
      Drug product
  • Lipid formulations for nucleic acid delivery
    Patent 9,364,435
    Issued: June 14, 2016
    Assignee(s): PROTIVA BIOTHERAPEUTICS, INC.

    The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.

    Patent expiration dates:

    • April 15, 2029
      ✓ 
      Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
      ✓ 
      Drug product
  • RNA interference mediating small RNA molecules
    Patent 9,567,582
    Issued: February 14, 2017
    Assignee(s): MAX-PLANCK-GESELLSCHAFT ZUR FÖRDERUNG DER WISSENSCHAFTEN E.V. MASSACHUSETTS INSTITUTE OF TECHNOLOGY WHITEHEAD INSTITUTE OF BIOMEDICAL TECHNOLOGY UNIVERSITY OF MASSACHUSETTS

    Double-stranded RNA (dsRNA) induces sequence-specific post-transcriptional gene silencing in many organisms by a process known as RNA interference (RNAi). Using a Drosophila in vitro system, we demonstrate that 19-23 nt short RNA fragments are the sequence-specific mediators of RNAi. The short interfering RNAs (siRNAs) are generated by an RNase III-like processing reaction from long dsRNA. Chemically synthesized siRNA duplexes with overhanging 3′ ends mediate efficient target RNA cleavage in the lysate, and the cleavage site is located near the center of the region spanned by the guiding siRNA. Furthermore, we provide evidence that the direction of dsRNA processing determines whether sense or antisense target RNA can be cleaved by the produced siRNP complex.

    Patent expiration dates:

    • March 30, 2021
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      Drug substance
      ✓ 
      Drug product
  • 2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations
    Patent 9,943,538
    Issued: April 17, 2018
    Assignee(s): Ionis Pharmaceuticals, Inc.

    Compositions comprising first and second oligomers are provided wherein at least a portion of the first oligomer is capable of hybridizing with at least a portion of the second oligomer, at least a portion of the first oligomer is complementary to and capable of hybridizing to a selected target nucleic acid, and at least one of the first or second oligomers includes a modified sugar and/or backbone modification. In some embodiments the modification is a 2′-OCH3 substituent group on a sugar moiety. Oligomer/protein compositions are also provided comprising an oligomer complementary to and capable of hybridizing to a selected target nucleic acid and at least one protein comprising at least a portion of an RNA-induced silencing complex (RISC), wherein at least one nucleotide of the oligomer has a modified sugar and/or backbone modification.

    Patent expiration dates:

    • November 4, 2023
      ✓ 
      Drug product
  • 2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations
    Patent 9,943,539
    Issued: April 17, 2018
    Assignee(s): Ionis Pharmaceuticals, Inc.

    Compositions comprising first and second oligomers are provided wherein at least a portion of the first oligomer is capable of hybridizing with at least a portion of the second oligomer, at least a portion of the first oligomer is complementary to and capable of hybridizing to a selected target nucleic acid, and at least one of the first or second oligomers includes a modified sugar and/or backbone modification. In some embodiments the modification is a 2′-OCH3 substituent group on a sugar moiety. Oligomer/protein compositions are also provided comprising an oligomer complementary to and capable of hybridizing to a selected target nucleic acid and at least one protein comprising at least a portion of an RNA-induced silencing complex (RISC), wherein at least one nucleotide of the oligomer has a modified sugar and/or backbone modification.

    Patent expiration dates:

    • November 4, 2023
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • August 10, 2023 - NEW CHEMICAL ENTITY
    • August 10, 2025 -

Further information

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Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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